Pharmaceutical Formulation Technology Research Papers (original) (raw)

3D printing (3DP) technologies have been attracting much recent interest as new methods of fabricating medicines and medical devices. Of the many types of 3DP available, stereolithographic (SLA) printing offers the unique advantage of being able to fabricate objects by cross-linking resins to form networked polymer matrices. Because water can be entrapped in these matrices, it is possible in principle to fabricate pre-wetted, drug-loaded hydrogels and devices. Here, SLA printing was used to prepare ibuprofen-loaded hydrogels of cross-linked polyethylene glycol diacrylate. Hydrogels containing up to 30% w/w water, and 10% w/w ibuprofen, were successfully printed. Dissolution profiles showed that drug release rates were dependent on water content, with higher water content hydrogels releasing drug faster. The conclusion is that SLA 3DP offers a new manufacturing route to pharmaceutical hydrogels.

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- Hydrogels, Pharmaceutics, Drug Delivery Systems, Ibuprofen

In this note, a novel probe fitted to a texture analyzer was described. This probe has the ability to simultaneously measure, in real-time, dimensional changes in the swollen layer and the glassy core of hydrophilic matrices when exposed to aqueous dissolution media. The utility of this probe was demonstrated on directly compressed tablets containing polymer blends, a water soluble additive, and theophylline as a model drug. Both the erosion and swelling fronts were measured for the same tablet every hour for 12 h. The probe provided accurate thickness data of the swollen region and the glassy core, and was able to demonstrate the swelling and subsequent erosion of the tablet with time. With this method, it is possible to simultaneously measure the swelling rate of the rubbery region and the erosion rate of the glassy core without operator intervention, which provides many advantages over the conventional approaches frequently reported in the literature.

- by Munier Nazzal
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- Materials Science, Nanotechnology, Medicine, Quantitative analysis

Vial ''Fogging'' is a phenomenon observed after lyophilization due to drug product creeping upwards along the inner vial surface. After the freeze-drying process, a haze of dried powder is visible inside the drug product vial, making it barely acceptable for commercial distribution from a cosmetic point of view. Development studies were performed to identify the root cause for fogging during manufacturing of a lyophilized monoclonal antibody drug product. The results of the studies indicate that drug product creeping occurs during the filling process, leading to vial fogging after lyophilization. Glass quality/ inner surface, glass conversion/vial processing (vial ''history'') and formulation excipients, e.g., surfactants (three different surfactants were tested), all affect glass fogging to a certain degree. Results showed that the main factor to control fogging is primarily the inner vial surface hydrophilicity/hydrophobicity. While Duran vials were not capable of reliably improving the level of fogging, hydrophobic containers provided reliable means to improve the cosmetic appearance due to reduction in fogging. Varying vial depyrogenation treatment conditions did not lead to satisfying results in removal of the fogging effect. Processing conditions of the vial after filling with drug product had a strong impact on reducing but not eliminating fogging.

Outer membrane vesicles (OMV) are used as a vaccine against Neisseria meningitidis serogroup B and are traditionally produced with detergent-extraction to remove toxic lipopolysaccharide. Engineered strains with attenuated lipopolysaccharide allowed the use of native vesicles (NOMV) with improved stability and immunogenicity. In the NOMV production process detergents are omitted and vesicle release is stimulated with EDTA extraction (a chelating agent) to enable a higher yield. Many process parameters may change the EDTA extraction efficiency, but it is unknown what the optimal ranges for these parameters are in terms of quality. The present study systematically optimized EDTA extraction and was representative for production at large-scale. Two critical process parameters were identified, harvest point of the cultivation (harvest) and pH of the extraction buffer (pH), which significantly affected yield (7-fold) and bacterial lysis (35-fold). The other quality attributes remained unchanged. Optimization of harvest and pH revealed that the desired low bacterial lysis coincided with intermediate but sufficient yield. High functional immunogenicity and low toxicity of the optimized vaccine were also confirmed. The EDTA extraction is therefore a robust process step which produces high quality OMV if harvest and pH are controlled accurately.

- by Michel Eppink
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- Biotechnology, Optimization, Biological Sciences, Lipopolysaccharide

The moderate heat treatment of amphotericin B (AmB) in its micellar form (M-AmB) results in superaggregates (H-AmB) that present a substantially lower toxicity and similar activity. The aim of this work was to evaluate the H-AmB behavior after a freeze-drying process. H-AmB and M-AmB micelles were evaluated before and after freeze-drying concerning their physicochemical and biological properties by spectrophotometry and activity/toxicity assay, respectively. Four concentrations of M-AmB and H-AmB were studied aiming to correlate their aggregation state and the respective biological behavior: 50 mg L −1 , 5 mg L −1 , 0.5 mg L −1 , and 0.05 mg L −1. Then, potassium leakage and hemoglobin leakage from red blood cells were used to evaluate the acute and chronic toxicity, respectively. The efficacy of M-AmB and H-AmB formulations was assessed by potassium leakage from Candida albicans and by the broth microdilution method. After heating, in addition to an evident turbidity, a slight blueshift from 327 to 323 nm was also observed at the concentrations of 50 and 5 mg L −1 for H-AmB. Additionally, an increase in the absorbance at 323 nm at the concentration of 0.5 mg L −1 was detected. Concerning the toxicity, H-AmB caused significantly lower hemoglobin leakage than M-AmB. These results were observed for H-AmB before and after freeze-drying. However, there was no difference between H-AmB and M-AmB concerning their activity. Accordingly, the freeze-drying cycle did not show any influence on the behavior of heated formulations, highlighting the suitability of such a method to produce a new AmB product with a long shelf life and with both greater efficiency and less toxicity.

- by Christian Silva
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- Chemistry, Pharmaceutical Technology, Pharmaceutical Chemistry, Medicine

Characteristics on admission of children on standardised protocol (n=334) and non-protocol children (n=293) were similar except that more children on standardised protocol had oedema, acidosis, and Vibrio cholerae isolated from stools.... more

- by Md. Golam Rabbani
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- Treatment Outcome, Bangladesh, Diarrhea, Diet Therapy

The use of medicines is an irreplaceable necessity in healthcare delivery. Application of advancing technology, especially the oral film techniques in pharmaceutical production has resulted in medicine availability in a trendy, readily acceptable and usable form, oral films. Although many literature abound on oral film delivery systems, there is paucity of work on recent incorporation of nanotechnology concepts and the potentials of this delivery system in improving medication adherence. Thus this work focuses on bridging this obvious gap. It reviews published works on the oral film technology, profiling recent advances in the nanoparticles incorporated into films, and necessary considerations in such formulations. It also explores oral films as a delivery system for improved adherence. Online search for articles on oral films production, marketed nanoparticle-based oral films, and the extensiveness of medication non-adherence was carried out using websites of researchgate, google search, film manufacturer's websites, google scholar and pubmed. Search terms used were 'marketed oral films', 'available medicines as oral films', 'nanotechnology in oral film production', 'oral film techniques', 'oral films manufacture + disease condition' and 'medicine adherence'. Articles were sorted on the basis of currency and practicality of information. The market space of oral film is growing steadily. Present use of oral film technology in delivering antipsychotics, antihistamines and analgesics is well received. Many drugs are currently incorporated into films in nano-sized forms to improve dissolution, bioavailability and effectiveness as revealed by the search. More can be achieved if this technology is extended to cover other classes of drugs such as antihypertensives, antiulcers and agents indicated for other chronic conditions. Fully exploring the unique features of the conventional oral films dosage forms and those embedded with nanoparticulate drug forms, therein lies the potentials to contribute to significant improvement in medication adherence even in chronic conditions.

- by Daniel Effiong
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- Pharmacy, Pharmaceutical Technology, Public Health, Drug Delivery System

Microbubbles system is a newly invented non-invasive technique in which, in the presence of ultrasound waves or harmonic sounds
micropores shrinks and agitated to produce micro bubbles within the applied area. These bubbles have the capability to target any perfused
tissues within our body. Recently it was postulated that due to its narrow size range (1 to 10μm vesicular diameter) it can get easily engulf
by phagocytic blood cells which can be very effective on lymphocytic cancer. Micro bubbles are prepared by using mechanical agitation,
ultrasonication, pressurized gas-liquid mixing system etc. Micro bubbles are made up of a monolayer of protein shells, lipid shells, surfactant
shells, polymer shells, Polyelectrolyte multilayer shells. Initially, microbubbles are used as diagnostic tools but due to its versatility of uses and properties of surface conjugation of proteins, genes, micro molecular nutrients, drugs slowly it’s becoming a therapeutic delivery tool. ALBUNEX® (GE Healthcare) was the first albumin conjugated micro bubble which was been approved by US-FDA. Recently importance is been given for brain targeting using Micro bubble carrier system. It was observed that using passive and active transport micro streamed bubbles can able to transport through Blood Brain Barrier (BBB). It is very important to give more importance to its stability and canonization of globules for more industrial acceptability.

The aim of the present study was to formulate and evaluate Metformin HCl microspheres to produce a drug delivery system with better pharmaceutical and therapeutic properties. Metformin HCl microspheres were prepared by using ethyl cellulose as a release retardant polymer by solvent evaporation method .Formulations F1, F2 and F3 were prepared using ethyl cellulose in the drug polymer ratio of 1:1, 1:2 and 1:3. A plasticizer (N-dibutyl phthalate) was added in formulations F4,F5 and F6 .The prepared microspheres were evaluated for the parameters like Percentage yield, Particle size analysis, Micromeritic properties like angle of repose, bulk density, tapped density, compressibility index, Hausner’s ratio, melting point determination, drug content estimation, microencapsulation efficiency and in vitro drug release studies. The in vitro release of Metformin HCl was slow and extended over longer period of time. As the concentration of polymer was increased, the drug release was decreased. The drug release was found to be slow in formulations F4, F5 and F6 when compared to F1, F2 and F3. Thus the study clearly indicated a promising potential of sustained release Metformin HCl microspheres containing ethyl cellulose as rate controlling polymer for effectively treating diabetes mellitus.

Abstract: Mesalamine is an anti-inflammatory drug used in the treatment of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. In contrast to the immediate-release oral solid dosage forms, mesalamine should exhibit delayed release achieved through an enteric coating intended to resist gastric fluid and release the drug into the colon region. The lack of application of the coating as well as the guarantee of the quality of the coating may result in aggravation of the disease due to the lack of desired therapeutic effect, since the drug may undergo dilutions prior to reaching the target. The objective of this study was to evaluate qualitatively the essential basic properties of oral solid dosage forms containing 800 mg of mesalamine produced in compounding pharmacies, identified as M1, M2 and M3, comparing them with the following pharmaceutical products: reference medicine (R) and generic (G). Samples were submitted to visual analysis and weight variation and disintegration tests. The results obtained in relation to the visual aspect and the tests related to weight were satisfactory for all the samples. On the other hand, the evaluation of the enteric performance was unsatisfactory for the samples M1 and M2, while the samples M3, R and G were approved in the acid and basic stages of the disintegration test. Thus, it may be inferred that compounding pharmaceutical establishments in Brazil have found difficulties in fulfilling the specifications necessary for mesalamine to reach the colon region, indispensable for its pharmacological effect.

Sacubitril/valsartan, traded under the brand name Entresto between others, is a fixed-dose combination medication for use heart failure. Sacubitril is a neprilysin inhibitor (A prodrug) and is used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure. It is anti-hypertensive drug. Valsartan is an Angiotensin Receptor Blocker (ARB) that may be used to treat a variety of cardiac conditions including hypertension, diabetic nephropathy and heart failure. Two UV-spectrophotometric methods have been developed and validated for simultaneous estimation of Sacubitril and Valsartan in a tablet dosage form. The first method employed solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 226.0 nm and 254.0 nm, max for Sacubitril and Valsartan, respectively. The second method was absorbance ratio method, which involves formation of Q-absorbance equation at 240 nm (isoabsorptive point) and also at 254 nm (max of Valsartan). The methods were found to be linear between the range of 4-12 g/mL for Sacubitril and 2-10 g/mL for Valsartan using Methanol as solvent. The mean percentage recovery was found to be 96.68%and 101.89% for the simultaneous equation method and 100.2% and 104.53% for the absorbance ratio method, for sacubitril and valsartan respectively. It could be concluded from the results obtained in the present investigation that the two methods for simultaneous estimation of sacubitril and valsartan in tablet dosage form are simple, rapid, accurate, precise and economical and can be used, successfully, in the quality control of pharmaceutical formulations and other routine laboratory analysis. The reviewed highlights various analytical techniques such as high-performance liquid chromatography (HPLC), ultraperformance liquid chromatography (UPLC), UV Spectroscopy, high performance thin layer chromatography (HPTLC), liquid chromatography coupled to tandem mass spectrometry (LC-MS), RP-HPLC and other chromatographic method used. The combination of these drugs with different method was examine and the commonly use of the drugs in hypertensive.

- by IJPSM Journal
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- Pharmacy, Clinical Pharmacology, Pharmacognosy, Pharmaceutical Chemistry
- by Jessica Josefsberg
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- Manufacturing, Vaccines, Biotechnology, Medicine

The chromatographic separation was Analytical method Development and validation plays an important role in the discovery, Development and manufacture of pharmaceuticals. The methods used ensure the identity, purity, potency, and performance of drug products. There are many factors to consider when developing methods. The majority of the analytical development effort goes into validating a stability indicating HPLC Method. The goal of the HPLC Method is try and separate quantify the main active drugs, any reaction impurities, all available synthetic intermediates and degradants. A new, simple, precise, rapid and accurate RP-HPLC (Reverse Phase-High Performance Liquid Chromatography) method has been developed for the simultaneous estimation of Atenolol (AT) and Amlodipine Besylate (AB) in tablet formulations. The chromatographic separation was achieved on Water's 717 Plus Autosampler HPLC using octadecysilane bonded C 18 , 5 µm, 250 cm x 4.6 mm column maintained at ambient temperature with mobile phase, Buffer: Acetonitrile: Methanol, Mobile phase-mix volume of acetonitrile 45 volume or methanole 35 volume a 5 ml Tetrabutyl ammonium hydroxide in 1000 ml with makeup HPLC water of a mixture 20 volume, flow rate 1.5 ml/min, load volume 2 l and a run time of 1 min he detection was performed at 225 nm. Buffer was prepared with Tetrabutyl ammonium hydroxide and adjusted pH to 3.0 with Ortho-Phosphoric Acid.

- by IJPSM Journal
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- Pharmacology, Chemistry, Pharmacy, Pharmaceutical Technology

Inflammation is a normal protective response to tissue damage mediated by Cyclooxygenase-2 (COX-2) enzyme. Cyclooxygenase enzymes are responsible for the production of prostaglandins. Increasing incidence and impact of inflammatory diseases have encouraged the search for new pharmacological strategies to face them. Pomegranate (Punica granatum L.) has been traditionally used as an anti-inflammatory and antioxidant, thus giving scope for anti-inflammatory studies. The aim of the present investigation to determine the anti-inflammatory activity and inhibitory effect on COX-2 enzyme of the ethanol extract of pomegranate rind (EEPR). The animals used in this study were male white rats which were divided into six groups, dose 20 mg/kg BW, dose 40 mg/kg BW, dose 80 mg/kg BW, positive control, negative control, and normal control. Determining of anti-inflammatory activity was carried out by inducing the soles of the rats with carrageenan and then measuring the edema volume using a plethysmometer and COX-2 inhibition is determined spectrophotometrically in a Microplate Reader. The results showed that EEPR (20 mg/kg BW and 40 mg/kg BW, and 80 mg/kg BW) had an inhibitory effect against prostaglandin synthesis by COX-2 and anti-inflammatory activity. These findings suggest that EEPR possesses promising anti-inflammatory activity, which is possibly mediated through inhibition COX-2 enzymes.

- by IJPSM Journal and +1
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- Pharmacology, Chemistry, Pharmacy, Indonesia

Social network is a group of individuals with diverse social interactions amongst them. The network large scale and distributed due to Quantitative analysis of networks is need of and in turn the society. Clustering helps us to group people with similar characteristics dense social networks. We have considered similarity measures for statistical When a social network is represented as a graph with members as nodes and their relation as edges, graph mining would be suitable for statistical analysis. We have chosen academic social network nodesto simplify network analysis. similaritybetween unstructured data elements extracted from social network.

Context: Colon cancer is a serious disease that can be hereditary or arise from exposure to carcinogens in unhealthy food. Current chemotherapy treatment has serious cardiovascular adverse effects, is not always effective, and there may be resistance to treatment. Recently, studies have found an optimal anticancer activity of modified pectins on colon cancer. Aims: To systematically review the scientific literature, with PRISMA guidelines, of the articles found in the last 11 years, on the potential anticancer effects of pectins on colon cancer. Methods: PRISMA and Rayyan were used for the selection of studies and a standardized search was followed in four databases with the terms: modified pectins, cancer, therapy. Data extraction was performed using Excel and relevant information on anticancer activity was collected. Results: In total, 16 articles were included, finding seven in vitro, three mixed and six in vivo studies. The anticancer activity and optimization of the formulation, encapsulation, release of pectin-based drugs were evaluated by different methods in 12 and six articles, respectively. Most of the studies were classified as high quality with the AXIS tool. Furthermore, 11 out of 12 articles showed positive effects of modified pectins on colon cancer both in vivo and in vitro and six out of six articles found positive effects on pectin-based formulations. Conclusions: The evidence found suggests a beneficial effect of modified pectins on colon cancer, however, more in vivo studies are required.

- by Gabino Garrido
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- Cancer, Meta-Analysis and Systematic Review, Schema therapy, Cancer Research

The pharmacologic preparation of the endometrium before hysteroscopy may be achieved with the use of various drugs. This systematic review aims to summarize the available evidence regarding the use of desogestrel for endometrial preparation before hysteroscopic procedures. A literature search for suitable articles published in English language from inception of the database until August 2019 was performed using the following databases: PubMed/MEDLINE, EMBASE, the Cochrane Library, and Google Scholar. All original articles concerning desogestrel-only pretreatment before hysteroscopic surgery were considered eligible. Reviews, case reports/series, conference papers, studies including the use of combined hormonal preparation, and articles in languages other than English were excluded from the analysis. The literature search retrieved 3 studies that met all the inclusion criteria. The data demonstrated that desogestrel may be considered as a hormonal pretreatment drug before hysteroscopic procedures. The drug was distinctly effective and assessed as helpful by the operating surgeon in numerous patients who were administered the pretreatment of 75 μg daily. Oral desogestrel is a cheap, easily available, safe, and quite efficient alternative for endometrial preparation before hysteroscopic procedures.

- by Antonio Simone Laganà
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- Surgery, Pharmacy, Medicine, Pharmaceutics

Propolis is a natural product with a plethora of biological effects, utilized by traditional medicine since antiquity. However, its application as a pharmaceutical is hindered by its variable composition and difficult standardization. CAPE has been shown to be a major component of propolis, with a large contribution to its pharmacological effects, among which the anti-inflammatory, antioxidant and antineoplastic have been attracting most attention. The current review article aims to present the cornerstone pharmacological studies of CAPE throughout the years, following its discovery, which confirmed its primary importance among propolis constituents and opened the path to its intensive research as a potential pharmaceutical. We present the diversity of drug delivery systems of CAPE, which have been developed to improve its efficacy in in vitro and in vivo disease models and discuss their primary promises and weaknesses. The increased interest in recent years over more practical approaches of CAPE research such as its pharmaceutical formulation comes to show that it has a potential to become commercialized as a pharmaceutical.

- by Yordan Yordanov
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- Pharmacology, Medical Sciences, Pharmacy, Natural Products

In an effort to enhance the assurance of product uniformity and to provide potential relief from blend sampling requirements, the Blend Uniformity Working Group (BUWG) of the Product Quality Research Institute (PQRI) has drafted a recommendation that describes an alternative approach for the assessment of the content uniformity of powder mixtures and the resulting dosage units. Although the sample sizes and acceptance criteria stated in this proposal have been derived through computer simulations, the BUWG called upon pharmaceutical companies to submit content uniformity data for blends, in-process dosage unit samples, and finished dosage forms to challenge the performance of the acceptance criteria stated in the recommendation. The data were also used to test the hypothesis; “blend uniformity testing in routine manufacture is not predictive of the uniformity of dosage units.”

- by Garth Boehm
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- Chemistry, Research, Medicine, Quality Control

The use of fused-filament 3D printing (FF 3DP) to fabricate individual tablets is demonstrated. The technology permits the manufacture of tablets containing drug doses tailored to individual patients, or to fabrication of tablets with specific drug-release profiles. Commercially produced polyvinyl alcohol (PVA) filament was loaded with a model drug (fluorescein) by swelling of the polymer in ethanolic drug solution. A final drug-loading of 0.29% w/w was achieved. Tablets of PVA/fluorescein (10mm diameter) were printed using a 3D printer. It was found that changing the degree of infill percentage in the printer software varied the weight and volume of the printed tablets. The tablets were mechanically strong and no significant thermal degradation of the active occurred during printing. Dissolution tests were conducted in modified Hank's buffer. The results showed release profiles were dependent on the infill percentage used to print the tablet. The study indicates that FF 3DP has...

- by abdul Basit
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- Materials Science, Pharmaceutical Technology, Medicine, Pharmaceutics

Background: Extraction is conducted to extract the important compounds in mangosteen peel using solvents at the different
time. Extraction time needs to be calculated so that the bioactive compound can be extracted optimally using the most
efficient solvent. The extraction of mangosteen peel was conducted by soaking in solvent at particular time (1-2 days in
general) without heating. Aim: This study aims to evaluate the effect of different solvents and maceration time on antioxidant
activity of mangosteen peel extract. Materials and Methods: The present research was conducted by extracting mangosteen
peel using ethanol (EtOH), acetone (Ace), ethyl acetate (EtOAc), methanol (MetOH), hexane (HX), acetic acid (AcetAc) and
aquadest (Aqua) at 24, 36 and 48h. Antioxidant activity was examined using visible UV spectrophotometer at the particular
wavelength. Result and Discussion: The result showed that the type of solvent and extraction time significantly (P<0.01)
affected antioxidant activity. Acetone extract of mangosteen peel is the most optimal solvent for antioxidant activity in
extraction time for 24 hours (IC50 = 9,468 + 0,324 ppm). A further test was required to obtain a better result using HPLC
method. Conclusion: It was evidenced that the properties of solvents, particularly polarity index and time, significantly
affected antioxidant activity.

- by Andri Kusmayadi
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- Pharmacology, Pharmacy, Drug Discovery, Pharmaceutical Sciences

abStract Gelatine is used as an excipient for various pharmaceutical dosage forms, such as capsule shells (both hard and soft), tablets, suspensions, emulsions and injections (e.g. plasma expanders). It is also broadly used in various industries such as food and cosmetics. Gelatine is a biopolymer obtained from discarded or unused materials of bovine, porcine, ovine, poultry and marine industrial farms. The discarded materials can be the skin, tendons, cartilages, bones and connective tissues. Gelatine sourced from animals is relatively easy and inexpensive to produce. The potential needs of gelatine cannot be overemphasised. Rising demands, health concerns and religious issues have heightened the need for alternative sources of gelatine. This review presents the various industrial uses of gelatine and the latest developments in producing gelatine from various sources. abStrak Gelatin diguna sebagai eksipien (bahan tambahan) dalam pelbagai bentuk dos farmaseutik seperti kelongsong kapsul (keras dan lembut), tablet, ampaian (suspensi), emulsi dan suntikan (contoh: pengembang plasma). Ia juga diguna dalam pelbagai industri lain seperti industri makanan dan kosmetik. Gelatin adalah biopolimer yang diperoleh daripada bahan-bahan terbuang atau yang tidak diguna daripada haiwan ternakan termasuk lembu, porsin, ovin, unggas dan ikan. Bahan-bahan terbuang ini adalah seperti kulit, tendon, rawan, tulang dan tisu penghubung. Gelatin daripada sumber haiwan adalah agak mudah dan murah untuk dihasilkan. Potensi gelatin tidak dapat dinafikan. Permintaan yang semakin meningkat, masalah kesihatan dan isu-isu agama telah meningkatkan keperluan untuk sumber alternatif gelatin. Tinjauan ini membentangkan pelbagai kegunaan gelatin dalam industri dan perkembangan terkini dalam penghasilan gelatin daripada pelbagai sumber.

- by Mohd Shakrie Palan Abdullah and +1
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- Pharmaceutical Technology, Pharmaceutical Formulation Technology, Pharmacy Law

A novel is ligand namely 5,5'-(6-(4-methoxyphenoxy)-1,3,5-triazine-2,4-diyl)bis (azanediyl)diquinolin-8-ol (PBDQ-6) has been prepared and characterized. This ligand was characterized by IR, 1H-NMR, and elemental analysis. Coordination polymers of this bis-ligand (NBDQ) were prepared with Cu(II), Ni(II), Co(II), Mn(II), and Zn(II) metal ions. All of these coordination polymers were characterized by elemental analyses, IR spectral and diffuse reflectance spectral studies. The thermal stability was evaluated by thermo gravimetric analyses (TGA). In addition, all of the coordination polymers have been characterized by their magnetic susceptibilities. All the novel synthesized compounds were screened for their antibacterial and antifungal activities.

Typhoid fever is a systemic infection caused by the bacterium Salmonella enterica subspecies enterica serotype typhi, a foremost public health predicament in developing countries. This study investigated hepatotoxicological changes associated with Salmonella typhi infection in Wistar rats and the potential of ethanol root extract of Millettia aboensis (EREMA) to reverse these changes. 51 animals were divided into six groups: group 1 was normal control with no treatment but were given feed and water ad libitum, group 2 was infected with Salmonella typhi without treatment (negative control), group 3, 4 and 5 were Salmonella typhi infected and treated with 100mg/kg, 200mg/kg and 400mg/kg of the extract respectively, and group 6 was infected and treated with 7.14mg/kg of ciprofloxacin. The animals were inoculated with a single infectious dose of Salmonella typhi bacterium (2.0 x 10 8 cfu/ml) and were subsequently treated with the graded doses of the extract and 7.14mg/kg of ciprofloxacin for a period of fifteen days. The rats were humanely sacrificed using diethyl ether anesthesia and blood samples taken for liver function investigation including [aspartate aminotransferase (AST) alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), Albumin, conjugate bilirubin (CB) and total protein (TP)] and liver harvested and processed for histological assessment. Inoculation with S. typhi caused significant increase in all the liver function parameters and different degrees of damages to the liver cells. These were all reversed on treatment with ethanol root extract of Millettia aboensis. Thus the extract exhibited both anti-Salmonella typhi as well as hepato-curative potentials on the Kuffer cells.

- by IJPSM Journal
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- Pharmacology, Pharmacy, Pharmaceutical Technology, Clinical Pharmacology

This study was performed to elucidate the influences of process and formulation design using power consumption and temperature measurements during granulation. Power consumption was recorded "in process" using a previously introduced computer program for optimal end-point detection at an early stage. The temperature increase (T) during granulation was recorded using a temperature sensor. The temperature increase in the wet powder bed expresses the friction forces at interparticle contacts occurring during granulation. The maxima of temperature profile occurred at 130% saturation, whereas the maxima of power consumption were determined at 100% saturation. The ratio of temperature and power consumption (TPR factor) is introduced as a signature of formulation design. TPR factor was found to be dependent on particle size, particle surface, water absorption capacity and solubility of the excipient and model drug, respectively. However, TPR factor was found to be independent of process design, such as the filling level of the mixer. Understanding and controlling the granulation process is a key factor in robust dosage form design. The "in process" control fits ideally the prerequisites of a drug quality system for the 21st century and FDA's Process Analytical Technology (PAT) initiative. The results of previous and present works of our research group will be used in a following step to develop an artificial neural network for granulation "in process" control.

- by Hans Leuenberger
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- Water, Starch, Pharmaceutics, Electricity

5G Network Architecture-A High Level View
5G Network Architecture A High-Level Perspective

- by David Vanderper
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- Health Sciences, Technology, Mobile Technology, Science
- by Varaporn Junyaprasert
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- Confocal Microscopy, Pharmaceutical Chemistry, Pharmaceutics, Antioxidants

Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance.

- by Christopher Holliman
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- Pharmaceutical Technology, Benchmarking, Quality Control, Consensus

Marine biological system could be a source of one of kind normal items which are primarily gathered in living life form and serves as valuable pharmacologically dynamic substances. Marine Medication could be a science of mending, keeping up and re-establishing wellbeing by anticipation and treatment in connection to sea subsidiaries. It has a related corollary field called Plunge. Pharmaceutical Marine Sponges, Molluscans, Green growth, Corals, Ascidians, Bryozoans and Vertebrates are major sources of biomedical compounds. The current situation in India is in an early stage, but steps are being taken within the right course to create a potential source of unused drugs. The most accentuation of marine sedate revelation is given in look of remedy for dangerous malady. Jumpers are uncovered to a number of physiological dangers as a result of introduction to profound ocean. Application of antihistamine drugs, pharmacotherapy and hyperbaric oxygen are thought of.

- by IJPSM Journal and +3
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- Pharmacology, Pharmacy, Medicinal Chemistry, Targeted Drug Delivery

This paper aims to provide the view for a single data management in pharmaceutical industry with cross application consistency. There are varied sources that contribute to data in any industry. The proper organization, easy flow and better connectivity of this data is essential for functioning in a suitable manner. Master data management is the basis on which the business processes can be developed and handled. Like any other industry, pharmaceutical as well incorporates several areas from which data can be gathered or manipulated. Also, there are diverse challenges that can act as a roadblock to smooth distribution of data. The article presents a detailed study of hierarchies in a pharma-based industry and the nature of problems faced by them at different levels. There are companies that face resistance while implementing Master Data Management. The manifold cause for this, when considering a pharmaceutical industry, have been outlined. This further encompasses the requirement of data governance and use of technology to strengthen the data management procedure. Finally, the article brings out possible approaches and vendor systems that can potentially create singularity in a pharmaceutical company, where data ranges from being ambiguous to highly specific. I. INTRODUCTION Master Data Management (MDM) organizations intend first to develop and then ensure the efficiency, integrity and accuracy of master data. It includes both operational structures and the monitoring of internal procedures. Both are challenging, but in the last mentioned, there are more difficulties. It seems that, in many organizations, no one is responsible for master data or lacks the resources to carry out such a task. Technical structures and operational processes are assisted by MDM initiatives, such as master data creation, master data quality improvement and knowledge architecture. Weak master data management results in a lack of market and efficiency goals, insufficiently concurred data control, fragmented data collection systems and a lack of effective data quality assurance. Master data is an organization's data center that is closely related to its operations and capabilities. In addition to the technical methods of dealing with MDM, it is often used as a set of strategies for dealing with each of the master data angles. It shows the support for company needs. Master Data Management (MDM) can be characterized as something that includes procedures, regulations, policies, standards and resources that reliably identify and maintain the organization's essential data to include a single point of reference, and that single point of reference is often referred to as golden record. MDM is also a rather far-reaching term, one that has the ability to be underestimated and misinterpreted, whether it is viewed as something too broad and complex to be applied successfully, or as something that can address virtually any data management challenge it poses. Review of each aspect of MDM will make a major difference to understanding what MDM should and should do and what it does not do.

- by Golam Mostofa Santo
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- Pharmaceutical Formulation Technology

The active pharmaceutical ingredient (API) of a dosage form is affected by number of mechanical and environmental factors which have a tendency to alter its crystalline state. Polymorphic transitions have been observed to occur during various unit operations like granulation, milling and compression. Forces of pressure, shear and temperature have an ability to induce alterations in crystal habit. A conversion in polymorphic form during a unit operation is very likely to affect the handling of API in the subsequent unit operation. Transitions have also been observed during storage of formulations where the relative humidity and temperature play a major role. An increase in temperature during storage can dehydrate or desolvate the crystal and hence produce crystal defects, whilst, high humidity conditions produce higher molecular mobility leading to either crystallization of API or alteration of its crystalline form.

- by Bharti Sapra
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- Water, Crystallization, Pharmaceutical Chemistry, Temperature

The solubility enhancement process of hydrophobic drugs is crucial in formulation development to achieve the bioavailability and therapeutic action of the drug at the target site. About 40% of the new chemical entities that have been identified by pharmaceutical industry screening programs face numerous problems in the formulation and development stage due to the poor water solubility and low bioavailability. Drug solubility and bioavailability enhancement are the important challenges in the field of formulation of pharmaceuticals. The Bio pharmaceutics Classification System depicts that Class II and IV drugs have a low water solubility, poor dissolution, and low bioavailability. This review highlights on the importance, advantages, disadvantages, techniques of solubility enhancement.

- by IJPSM Journal
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- Pharmacology, Chemistry, Pharmacy, Pharmaceutical Education

Verapamil hydrochloride (VCL) is a drug with narrow therapeutic index commonly used in the treatment of mild or moderate systemic arterial hypertension and myocardial ischemia. We have performed pharmaceutical equivalence and comparative dissolution profile studies between reference (R) and several generic (G) medications comprising immediate release coated tablets of VCL (80mg). The analyses were carried out according to the general methods and monograph provided by the Brazilian Pharmacopoeia. The generic medications G1, G2, G3 and G4 were pharmaceutical equivalents to the R, as they were approved in tests of average weight, hardness, friability, disintegration, drug content and uniformity of unit dose. The R, G1, G3 and G4 were all approved at the stage 1 of the dissolution test, while G2 was approved at stage 2. However, none of the G presented dissolution profile similar to the R (18.36 ≤ F2 ≤ 45.15), which may indirectly impair their therapeutical efficacy. Data arising from this study reinforce the necessity of more commitment from the companies producing generic medications in Brazil with the Good Manufacturing Practices and quality of such products, aiming at the promotion of health and overall wellness.

- by Jonathan Burbaum
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- Bioinformatics, Information Technology, Mass Spectrometry, Arsenic

A simple, fast and accurate method has been developed for the estimation of benzene content in Lovastatin by Gas Chromatography. The analysis was carried out on Perkin Elmer Clarus 600 GC-HS Chromatograph. The column used was DB-624 30m X 0.32 mm X 1.8 µm fused silica analytical column (6% cyanopropylphenyl 94 % dimethylpolysiloxane as a stationary phase).The detector used was FID detector.

The thermodynamic properties of phenacetin in solid state and in saturated conditions in neat and binary solvents were characterized based on differential scanning calorimetry and spectroscopic solubility measurements. The temperature-related heat capacity values measured for both the solid and melt states were provided and used for precise determination of the values for ideal solubility, fusion thermodynamic functions, and activity coefficients in the studied solutions. Factors affecting the accuracy of these values were discussed in terms of various models of specific heat capacity difference for phenacetin in crystal and super-cooled liquid states. It was concluded that different properties have varying sensitivity in relation to the accuracy of heat capacity values. The values of temperature-related excess solubility in aqueous binary mixtures were interpreted using the Jouyban-Acree solubility equation for aqueous binary mixtures of methanol, DMSO, DMF, 1,4-dioxane, and acetonitrile. All binary solvent systems studied exhibited strong positive non-ideal deviations from an algebraic rule of mixing. Additionally, an interesting co-solvency phenomenon was observed with phenacetin solubility in aqueous mixtures with acetonitrile or 1,4dioxane. The remaining three solvents acted as strong co-solvents.

The purpose of this work was to formulate and prepare fast dissolving
tablets of azilsartan kamedoxomil which is practically insoluble drug
for improving its poor oral bioavailability and with the aim of
alleviating administration to patients facing problems with
swallowing. Tablets were prepared adopting effervescent and
sublimation techniques. Ac-Di-Sol, explotab, crospovidone and
glycine were used as superdisintigrants along with blend of sodium
bicarbonate, citric acid (as effervescent mixture) and menthol and
ammonium carbonate (as sublimating agents). The mixture was
directly compressed using Avicel PH 102, Sorbitab and lactose fast
flow as diluent. Pre-compression parameters such as bulk density,
tapped density, bulkiness, compressibility (Carr's index), Hausner
ratio and angle of repose were evaluated. Post-compression
parameters such as weight variation, content uniformity, hardness,
friability, disintegration time, in-vitro dispersion time, wetting time,
water absorption ratio and in vitro dissolution were performed and
compared to commercially product Edarbi® 40mg tablets. Results
revealed that SD2, SD3, SD4, EF4 and EF6 could increase amount of
azilsartan kamedoxomil dissolved to more than 80% within 10min.
Stability studies were performed on the selected formulae namely;
SD2, SD3, SD4, EF4, EF6 and Edarbi® 40mg tablets. The
physicochemical properties of stored tablets were performed

- by Asmaa Bayoumi
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- Pharmaceutical Formulation Technology
- by Elijah Ngule
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- Pharmaceutical Formulation Technology

Carvedilol is an antihypertensive drug use for management of Hypertension. It has the half-life of 6 hr and oral bioavailability of 25% due to first pass metabolism. The total daily dose of Carvedilol is 25 mg, hence it required frequent dosing. Transdermal patches of Carvedilol were prepared for sustained release and improve bioavailability of drug and patient compliance. Different formulations were prepared by varying the amount of HPMC-K4M and Eudragit RS-100 by solvent casting method. The prepared formulations were evaluated for various parameters like thickness, tensile strength, folding endurance, % elongation, % moisture content, % moisture uptake, % drug content, In-vitro drug release, In-vitro permeation and skin irritation study. A 32 full factorial design was applied to check the effect of varying the amount of Eudragit-RS 100 (X1) and amount of HPMC-K4M (X2) on the responses i.e. tensile strength and percentage drug released in 20 hr (Q20) as dependent variables. Regression analysis and analysis of variance were performed for dependent variables. In-vitro release data were fitted to various models to ascertain kinetic of drug release. The best selected formulation is subjected to in-vitro skin permeation and skin irritation study. Batch F7 was considered optimum batch which contained 400 mg of Eudragit RS-100 and 600 mg of HPMC-K4M, showed release 95.73% up to 24 hr and was more similar to Zero order release kinetics (r2=0.982). Batch F7 showed flux of 125.8 μg/cm2/h, hence the patch area of 1.33 cm2 would be expected to deliver targeted flux of 83.72μg/cm2/h.

Objective: The main aim of this study was to design a drug carrier capable to control and enhance the release of poorly water soluble drugs. Methods: Three polymeric formulations, based on poly (2-hydroxyethyl methacrylate) and loaded with different Capmul ® MCM C8 concentrations (0, 10 and 20 % w/w), were prepared. Felodipine, which is a poorly soluble substance, was selected as a model drug. The effect of Capmul ® MCM C8 on swelling behavior and in vitro release profile of the prepared polymer was investigated in PBS. Results: The swelling profiles of all formulations were statistically similar, which indicated the non-significant effect of added Capmul ® MCM C8 on polymer's swelling behavior. All formulations showed a delayed drug release. Formulation-F3, which is loaded with 20% w/w Capmul ® MCM C8 displayed a significant higher release compared to the other formulations. Conclusion: Capmul ® MCM products, which are widely used in food industries, can be used to improve the oral delivery of poorly soluble substances. The optimized formulation exhibited the ability to control and enhance the release of the model drug.

- by Mohammad F. Bayan
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- Pharmacy, Pharmaceutical Technology, Pharmaceutics, Pharmaceuticals

The suspending properties of Dicerocaryum zanguebarium and Adansonia digitata gum were evaluated at concentrations of (2.5, 5.0 and7.5%w/v) and (1.25 and 5.0%w/v) in calamine lotion suspension respectively. The physicochemical properties of the gums evaluated were sedimentation volume (F), viscosity, flow rate and compared with those of the suspension that had no suspending agent
as a negative control. At all concentrations formulated, Dicerocaryum zanguebarium gum had the strongest suspending ability relative to the Adansonia digitata in calamine lotion. The viscosity of the suspension formulations ranged from 7.18-26.4 centipoise, which was a function of the concentration and type of suspending agent as well as the duration of storage of the suspension. Sedimentation
volume, ease of redispersion and the flow rate of the formulations were characteristic of the suspending agent used and were influenced by the concentration of the agent. The profiles of calamine lotion suspension formulations containing Dicerocaryum zanguebarium were better than those of Adansonia digitata irrespective of the concentration of the suspending agent. Dicerocaryum zanguebarium gum could be a potential suspending agent in formulation of pharmaceutical suspensions and help prevent caking in the formulation.

A simple UV-Visible spectrophotometric method has been
developed for the determination of Atorvastatin in its pure form as
well as pharmaceutical dosage form using Methyl Orange reagent.
The method is based on the measurement of absorbance of
Atorvastatin in methanol at 410 nm. The Beer’s law is obeyed
over the linear range 50-300μg /ml of Atorvastatin. All the
variables were studied to optimize the reaction conditions. No
interference was observed in the presence of common
pharmaceutical excipients. The validity of the method was tested
by analyzing the drug in its pharmaceutical preparations. Good
recoveries were also obtained. Assay for the tablet preparation was
performed using UV-Visible spectrophotometric method and the
results were found to be within acceptable limits.

Choosing the proper drug product is getting complicated for health professionals and patients due to the existence of abundant generic brands in local drug market. The study was intended to evaluate the different physical parameters of generic amlodipine besylate tablet from different manufacturers using in vitro tests in order to minimize health risk factors and maximize the safety of local people. Six brands (A, B, C, D, E and F) of amlodipine besylate tablets (5 mg) marketed in Bangladesh were evaluated for eight in vitro tests including both official and unofficial viz. diameter test, thickness test, hardness test, friability test, uniformity of weight, disintegration test, dissolution test and assay. Dissolution study revealed brand B (99.87%) was the fastest and brand D (87.19%) was the slowest in terms of drug release. Using a validated UV spectrophotometric method assay value was recorded within 92% to 98.70%. Such study serves as a good pointer for assessment of in vitro parameters of commercially available products which may be advantageous for future formulation development studies.

- by James Regun Karmoker and +2
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- Pharmacy, Pharmaceutical Technology, Bangladesh, Pharmaceutical Formulation Technology

One of the significant purposes of nanotechnology in the field of medical science is the utilization of
nanotechnology in drug delivery to target the tissue for the treatment of disease like diabetes. The biologically
compatible nanoparticles with biological, chemical, physical properties may be useful to enhance and overcome
the limitations which are caused in the use of traditional medicine system by boosting the rate of drug release
,enhancing drug solubility, and improving the diffusion and distribution of drugs. In this review, we have
highlighted on the term diabetes and its different types. Diabetes is becoming an epidemic, more than 366
millions of people around the world are affected. This, article also focuses on the role of nanoparticles in the
management of diabetes also its different types of as well as its applications and uses in the treatment of
diabetes.

- by IJPSM Journal
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- Pharmacology, Pharmacy, Diabetes, Pharmaceutical Technology

A new simple, accurate, precise and reproducible Ion chromatography method has been developed for the estimation of Methane sulfonic acid in Busulfan injectable dosage. The method which is developed is also validated in complete compliance with the current regulatory guidelines by using well developed analytical method validation techniques and tools which comprises with the analytical method validation parameters like Linearity, LOD and LOQ determination, Accuracy, Method precision, Specificity, System suitability, Robustness, Ruggedness etc. by adopting the current method the linearity obtained is near to 0.999 and thus this shows that the method is capable to give a good detector response, the recovery calculated was within the range of 85% to 115% of the specification limits.