Nishith Patel - Academia.edu (original) (raw)
Papers by Nishith Patel
Atorvastatin calcium is the drug used for treating hypercholesterolemia. Microemulsions are used ... more Atorvastatin calcium is the drug used for treating hypercholesterolemia. Microemulsions are used as edge as potential drug delivery vehicles because of their thermodynamic stability, reversibility, simple manufacturing, and scale up feasibility, and do not require any special equipment. Microemulsion based tablet of atorvastatin calcium was formulated using avicel 101 as career and aerosil as coating material. A32 full factorial design was carried out to optimise oil: smix ratio and % SSG for the formulation of tablet. Regression analysis was carried out for dependent variable and full and reduced polynomial equations ware generated for each variable. The response plot and counter plot were prepared for each response to check effect of each variable on response. Using check point batch the polynomial equations were validated and optimised batch were formulated using extensive grid search on overlay counter plot and polynomial equation. The optimised formulation was evaluated for flo...
The present study was aimed towards the formulation and development of fast disintegrating tablet... more The present study was aimed towards the formulation and development of fast disintegrating tablets by direct compression technology using Ranitidine HCl as a model drug. Fast disintegrating tablet of Ranitidine HCl was formulated using three Superdisintegrates in different concentrations i.e. 10 mg, 20 mg and 30 mg, and one disintegrates having concentration i.e. 10 mg, 20 mg and 30 mg like Croscarmellose sodium, Crospovidone, Sodium Starch Glycolate. All the batches were prepared by direct compression method using the Cadmach Single punch tablet compression machine using 14X32 mm flat punch. Disintegration time and drug release were taken as the basis to optimize the immediate release tablet. Prepared tablets were evaluated for thickness, hardness, friability, uniformity of weight, disintegration time and dissolution study. Tablets containing 10 mg Croscarmellose sodium and 10 mg Crospovidone showed the faster disintegration time (22-25 Secs) and % drug release (100.8 % in 15mins) ...
Pharmacokinetics and Pharmacodynamics of Nanoparticulate Drug Delivery Systems
Sustainable Nanotechnology
Liquisolid technique is a novel approach for the concept of dosage formulation to improve the bio... more Liquisolid technique is a novel approach for the concept of dosage formulation to improve the bioavailability, dissolution rates and rapid disintegration of water insoluble drugs via oral route of administration. In this technique of formulation involves drugs dissolved in suitable non-volatile liquid vehicles, and converted in to powdered forms of liquid medications compact, they are compressible and acceptably industrial applicable by combination with selective powder excipients. The liquisolid technique allows the formulation transformation into solid drug delivery systems. With this technique as compare to commercial conventional tablet it shows confirmed increasing dissolution rates in addition to improved bioavailability. Approach has been successfully applied for poorly soluble drugs in release of low dose enhancement. However, for the high dose drugs one of the limitations for the formulation because of more liquid/vehicle required for the drug dissolution procedure as well ...
Based on the literature review, it was found that a number of studies involving method developmen... more Based on the literature review, it was found that a number of studies involving method development for estimation of GABAPENTIN and NORTRIPTYLINE have been carried out in formulations/biological fluid. Thus, a number of analytical methods have been developed for estimation of both drugs individually and in combination with other drugs. Review of literature reveals that no chromatographic and Spectroscopic methods have been reported for simultaneous estimation of Gabapentin and Nortriptyline. In the Bulk drug and Pharmaceutical dosage form. Therefore it is found that there is a need to develop an analytical method for simultaneous estimation of Gabapentin and Nortriptyline. in formulations. So the present work is aimed for Development of simple and reproducible chromatographic (RP-HPLC) and spectrophotometric (UV Spectroscopic method) method for simultaneous estimation of Gabapentin and Nortriptyline. Validation of the developed chromatographic and spectroscopic method as per ICH gui...
In current study formulation of self emulsifying drug delivery system of Fenofibrate was carried ... more In current study formulation of self emulsifying drug delivery system of Fenofibrate was carried out using Lipd phase, emulsifier and co emulsifier flax seed oil, tween 20 and polyethylene glycol 600 respectively. various oil, emulsifier and co emulsifiers were selected based on their solubility. Using water titration method ternary phase diagram ware prepared for SEDDS and emulsification region were analysed visually. All prepared formulations were evaluated for dilution studies, self emulsification time, drug content, in-vitro dissolution, droplet size determination, zeta potential measurement, viscosity determination and thermodynamic stability study. Based on stability study results, viscosity and usage of less emulsifier the final formulation were prepared. The comparison of invitro dissolution study of final formulation shows 5.4 fold and 1.8 fold increases in dissolution at 60 min with pure drug and marketed formulation respectively.
Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In preformulat... more Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In preformulation study solid dispersions by solvent evaporation technique were prepared to enhance solubility. Different ratios of PEG 6000 to Glimperide were taken for solid dispersion. The Films of Glimepiride solid dispersion equivalent to 2mg Glimiperide , were developed by solvent casting method using different Polymers, HPMC K4M, Sodium CMC, carbopol 971P and polyox. The prepared mucoadhesive buccal patches were evaluated for Swelling index, Residence time, Folding endurance, Tensile strength and Mucoadhesive strength. In vitro release was carried out in simulated saliva solution using modified USP type II apparatus at 50 rpm. Ex vivo release studies were performed with few selected batches and its results along with evaluation parameter were taken in to account to select optimized batch. The release of Glimepiride from developed formulations was found to be fickian diffusion controlled. A Shor...
A new, simple, accurate and sensitive UV-spectrophotometric absorption correction method has been... more A new, simple, accurate and sensitive UV-spectrophotometric absorption correction method has been developed for simultaneous determination of Metformin HCl and Repaglinide in bilayer tablet dosage form utilizing concept of standard addition. The method is based upon determination of Repaglinide at 299 nm where Metformin HCl shows zero absorbance & Metformin HCl at 208 nm in 0.1N HCl as a solvent & in phosphate buffer pH 6.8 Repaglinide at 283 nm where Metformin HCl shows zero absorbance & Metformin HCl at 232.4 nm. Linearity was observed in range of 10-60 μg/ml and 1-6 μg/ml for Metformin HCl and Repaglinide respectively. The correlation coefficient value was found to be 0.989-0.9998. All methods were statistically validated as per ICH guidelines and can be successively applied for analysis of tablets formulation.
The objective of this present study was to design bilayer tablet of two different drugs for separ... more The objective of this present study was to design bilayer tablet of two different drugs for separate release, evaluation of the same and comparison dry granulation formulation with minor changes in components. Both layer of bilayer tablets comprised control release. In wet granulation different type and amount of polymer were used for each layer. The formulated bilayer tablets were evaluated for pre compression as well as post compression parameters including invitro_dissolution_study were carried out. The results showed that wet granulation of formulated bilayer tablet carried out with different polymers viz. Gum acacia, Guar gum, Acrypol -971, HPMC_ K100M, eudragit_RSPO was carried out and based on its release retarding properties. Based on drug release and release kinetics study final formulation was selected that was further analysed for stability study. The accelerated stability study for 6 month showed affirmative results
In the pharmaceutical research and development the novel drug delivery system (NDDS) plays remark... more In the pharmaceutical research and development the novel drug delivery system (NDDS) plays remarkable performance. A milestone in oral NDDS is innovative and highly versatile drug delivery system. ODDS use the principle of osmotic pressure, as an energy source, for the delivery of drugs. Oral osmotic drug delivery systems with their versatile and their highly predictable drug release rates offer various biomedical advantages. Osmosis is one type of aristocrat phenomenon that seizes the attention for its exploitation in zero-order drug delivery systems. The drug delivered from these systems is not reliable of pH and the physiological conditions. Optimizing semipermeable membrane and the osmotic agents can modulate drug release from the system. In this article, a detailed description of various oral osmotically driven systems along with their formulation aspects, therapeutic applications and evaluation techniques are described.
Amongst various carrier systems, liposomes have generated a great interest because of their versa... more Amongst various carrier systems, liposomes have generated a great interest because of their versatility. Liposomes not only deliver both hydrophilic and lipophilic medicaments for cancer, immunomodulation, diagnostics, antibiotics, antifungal, opthalmics, aniashamatic, vaccines, enzyme and genetic modification, but also gives wide choice of delivery like pulmonary, oral, vaginal, brain, transdermal, systemic, vaccine and antigen delivery with advantage of low cost, greater stability, purity of raw material, ease of storage. Although there are certain factors and hurdles that affect the development of liposome drug delivery system. About 40 years has been passed but still the delivery system is on R & D scale and only few countable liposome products have been reached to market. Here in this review some of these possible reasons and hurdles in the liposome drug delivery system are being discussed.
Melt in mouth tablets are oral solid dosage form which when placed on tongue disintegrates rapidl... more Melt in mouth tablets are oral solid dosage form which when placed on tongue disintegrates rapidly, releasing the drug, which dissolves or disperses in the saliva and then swallowed with or without heat of saliva. Melt in Mouth tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. It is very important drug delivery system in case where drug absorbed from buccal cavity. Rapid disintegration of tablet cause quick dissolution and thus fast onset of action. It provides good stability, accurate dosing, easy manufacturing, reduced packaging size; self administration is possible during travelling as water is not required and easy to handle by patients. It is easy to administer for pediatric, geriatric, and institutionalized patients especially for uncooperative patients.
ABSTRACT: Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In p... more ABSTRACT: Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In preformulation study solid dispersions by solvent evaporation technique were prepared to enhance solubility. Different ratios of PEG 6000 to Glimperide were taken for solid dispersion. The Films of Glimepiride solid dispersion equivalent to 2mg Glimiperide , were developed by solvent casting method using different Polymers, HPMC K4M, Sodium CMC, carbopol 971P and polyox. The prepared mucoadhesive buccal patches were evaluated for Swelling index, Residence time, Folding endurance, Tensile strength and Mucoadhesive strength. In vitro release was carried out in simulated saliva solution using modified USP type II apparatus at 50 rpm. Ex vivo release studies were performed with few selected batches and its results along with evaluation parameter were taken in to account to select optimized batch. The release of Glimepiride from developed formulations was found to be fickian diffusion controll...
Atorvastatin calcium is the drug used for treating hypercholesterolemia.Microemulsions are used a... more Atorvastatin calcium is the drug used for treating hypercholesterolemia.Microemulsions are used as edge as potential drug deliveryvehicles because of their thermodynamic stability, reversibility,simple manufacturing, and scale up feasibility, and do not requireany special equipment. Microemulsionbased tablet of atorvastatin calcium was formulated using avicel 101 as career and aerosil as coating material. A32 full factorial design was carried out to optimise oil: smix ratio and % SSG for the formulation of tablet. Regression analysis was carried out for dependent variable and full and reduced polynomial equations ware generated for each variable. The response plot and counter plot were prepared for each response to check effect of each variable on response. Using check point batch the polynomial equations were validated and optimised batch were formulated using extensive grid search on overlay counter plot and polynomial equation. The optimised formulation was evaluated for flow property, hardness, friability, disintegration time, emulsification time, and invitro drug release. Drug release kinetic of optimised batch showed fickian diffusion type drug release. A stability study and comparison study with marketed formulation was carried out on optimise formulation.
Atorvastatin calcium is the drug used for treating hypercholesterolemia. Microemulsions are used ... more Atorvastatin calcium is the drug used for treating hypercholesterolemia. Microemulsions are used as edge as potential drug delivery vehicles because of their thermodynamic stability, reversibility, simple manufacturing, and scale up feasibility, and do not require any special equipment. Microemulsion based tablet of atorvastatin calcium was formulated using avicel 101 as career and aerosil as coating material. A32 full factorial design was carried out to optimise oil: smix ratio and % SSG for the formulation of tablet. Regression analysis was carried out for dependent variable and full and reduced polynomial equations ware generated for each variable. The response plot and counter plot were prepared for each response to check effect of each variable on response. Using check point batch the polynomial equations were validated and optimised batch were formulated using extensive grid search on overlay counter plot and polynomial equation. The optimised formulation was evaluated for flo...
The present study was aimed towards the formulation and development of fast disintegrating tablet... more The present study was aimed towards the formulation and development of fast disintegrating tablets by direct compression technology using Ranitidine HCl as a model drug. Fast disintegrating tablet of Ranitidine HCl was formulated using three Superdisintegrates in different concentrations i.e. 10 mg, 20 mg and 30 mg, and one disintegrates having concentration i.e. 10 mg, 20 mg and 30 mg like Croscarmellose sodium, Crospovidone, Sodium Starch Glycolate. All the batches were prepared by direct compression method using the Cadmach Single punch tablet compression machine using 14X32 mm flat punch. Disintegration time and drug release were taken as the basis to optimize the immediate release tablet. Prepared tablets were evaluated for thickness, hardness, friability, uniformity of weight, disintegration time and dissolution study. Tablets containing 10 mg Croscarmellose sodium and 10 mg Crospovidone showed the faster disintegration time (22-25 Secs) and % drug release (100.8 % in 15mins) ...
Pharmacokinetics and Pharmacodynamics of Nanoparticulate Drug Delivery Systems
Sustainable Nanotechnology
Liquisolid technique is a novel approach for the concept of dosage formulation to improve the bio... more Liquisolid technique is a novel approach for the concept of dosage formulation to improve the bioavailability, dissolution rates and rapid disintegration of water insoluble drugs via oral route of administration. In this technique of formulation involves drugs dissolved in suitable non-volatile liquid vehicles, and converted in to powdered forms of liquid medications compact, they are compressible and acceptably industrial applicable by combination with selective powder excipients. The liquisolid technique allows the formulation transformation into solid drug delivery systems. With this technique as compare to commercial conventional tablet it shows confirmed increasing dissolution rates in addition to improved bioavailability. Approach has been successfully applied for poorly soluble drugs in release of low dose enhancement. However, for the high dose drugs one of the limitations for the formulation because of more liquid/vehicle required for the drug dissolution procedure as well ...
Based on the literature review, it was found that a number of studies involving method developmen... more Based on the literature review, it was found that a number of studies involving method development for estimation of GABAPENTIN and NORTRIPTYLINE have been carried out in formulations/biological fluid. Thus, a number of analytical methods have been developed for estimation of both drugs individually and in combination with other drugs. Review of literature reveals that no chromatographic and Spectroscopic methods have been reported for simultaneous estimation of Gabapentin and Nortriptyline. In the Bulk drug and Pharmaceutical dosage form. Therefore it is found that there is a need to develop an analytical method for simultaneous estimation of Gabapentin and Nortriptyline. in formulations. So the present work is aimed for Development of simple and reproducible chromatographic (RP-HPLC) and spectrophotometric (UV Spectroscopic method) method for simultaneous estimation of Gabapentin and Nortriptyline. Validation of the developed chromatographic and spectroscopic method as per ICH gui...
In current study formulation of self emulsifying drug delivery system of Fenofibrate was carried ... more In current study formulation of self emulsifying drug delivery system of Fenofibrate was carried out using Lipd phase, emulsifier and co emulsifier flax seed oil, tween 20 and polyethylene glycol 600 respectively. various oil, emulsifier and co emulsifiers were selected based on their solubility. Using water titration method ternary phase diagram ware prepared for SEDDS and emulsification region were analysed visually. All prepared formulations were evaluated for dilution studies, self emulsification time, drug content, in-vitro dissolution, droplet size determination, zeta potential measurement, viscosity determination and thermodynamic stability study. Based on stability study results, viscosity and usage of less emulsifier the final formulation were prepared. The comparison of invitro dissolution study of final formulation shows 5.4 fold and 1.8 fold increases in dissolution at 60 min with pure drug and marketed formulation respectively.
Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In preformulat... more Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In preformulation study solid dispersions by solvent evaporation technique were prepared to enhance solubility. Different ratios of PEG 6000 to Glimperide were taken for solid dispersion. The Films of Glimepiride solid dispersion equivalent to 2mg Glimiperide , were developed by solvent casting method using different Polymers, HPMC K4M, Sodium CMC, carbopol 971P and polyox. The prepared mucoadhesive buccal patches were evaluated for Swelling index, Residence time, Folding endurance, Tensile strength and Mucoadhesive strength. In vitro release was carried out in simulated saliva solution using modified USP type II apparatus at 50 rpm. Ex vivo release studies were performed with few selected batches and its results along with evaluation parameter were taken in to account to select optimized batch. The release of Glimepiride from developed formulations was found to be fickian diffusion controlled. A Shor...
A new, simple, accurate and sensitive UV-spectrophotometric absorption correction method has been... more A new, simple, accurate and sensitive UV-spectrophotometric absorption correction method has been developed for simultaneous determination of Metformin HCl and Repaglinide in bilayer tablet dosage form utilizing concept of standard addition. The method is based upon determination of Repaglinide at 299 nm where Metformin HCl shows zero absorbance & Metformin HCl at 208 nm in 0.1N HCl as a solvent & in phosphate buffer pH 6.8 Repaglinide at 283 nm where Metformin HCl shows zero absorbance & Metformin HCl at 232.4 nm. Linearity was observed in range of 10-60 μg/ml and 1-6 μg/ml for Metformin HCl and Repaglinide respectively. The correlation coefficient value was found to be 0.989-0.9998. All methods were statistically validated as per ICH guidelines and can be successively applied for analysis of tablets formulation.
The objective of this present study was to design bilayer tablet of two different drugs for separ... more The objective of this present study was to design bilayer tablet of two different drugs for separate release, evaluation of the same and comparison dry granulation formulation with minor changes in components. Both layer of bilayer tablets comprised control release. In wet granulation different type and amount of polymer were used for each layer. The formulated bilayer tablets were evaluated for pre compression as well as post compression parameters including invitro_dissolution_study were carried out. The results showed that wet granulation of formulated bilayer tablet carried out with different polymers viz. Gum acacia, Guar gum, Acrypol -971, HPMC_ K100M, eudragit_RSPO was carried out and based on its release retarding properties. Based on drug release and release kinetics study final formulation was selected that was further analysed for stability study. The accelerated stability study for 6 month showed affirmative results
In the pharmaceutical research and development the novel drug delivery system (NDDS) plays remark... more In the pharmaceutical research and development the novel drug delivery system (NDDS) plays remarkable performance. A milestone in oral NDDS is innovative and highly versatile drug delivery system. ODDS use the principle of osmotic pressure, as an energy source, for the delivery of drugs. Oral osmotic drug delivery systems with their versatile and their highly predictable drug release rates offer various biomedical advantages. Osmosis is one type of aristocrat phenomenon that seizes the attention for its exploitation in zero-order drug delivery systems. The drug delivered from these systems is not reliable of pH and the physiological conditions. Optimizing semipermeable membrane and the osmotic agents can modulate drug release from the system. In this article, a detailed description of various oral osmotically driven systems along with their formulation aspects, therapeutic applications and evaluation techniques are described.
Amongst various carrier systems, liposomes have generated a great interest because of their versa... more Amongst various carrier systems, liposomes have generated a great interest because of their versatility. Liposomes not only deliver both hydrophilic and lipophilic medicaments for cancer, immunomodulation, diagnostics, antibiotics, antifungal, opthalmics, aniashamatic, vaccines, enzyme and genetic modification, but also gives wide choice of delivery like pulmonary, oral, vaginal, brain, transdermal, systemic, vaccine and antigen delivery with advantage of low cost, greater stability, purity of raw material, ease of storage. Although there are certain factors and hurdles that affect the development of liposome drug delivery system. About 40 years has been passed but still the delivery system is on R & D scale and only few countable liposome products have been reached to market. Here in this review some of these possible reasons and hurdles in the liposome drug delivery system are being discussed.
Melt in mouth tablets are oral solid dosage form which when placed on tongue disintegrates rapidl... more Melt in mouth tablets are oral solid dosage form which when placed on tongue disintegrates rapidly, releasing the drug, which dissolves or disperses in the saliva and then swallowed with or without heat of saliva. Melt in Mouth tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. It is very important drug delivery system in case where drug absorbed from buccal cavity. Rapid disintegration of tablet cause quick dissolution and thus fast onset of action. It provides good stability, accurate dosing, easy manufacturing, reduced packaging size; self administration is possible during travelling as water is not required and easy to handle by patients. It is easy to administer for pediatric, geriatric, and institutionalized patients especially for uncooperative patients.
ABSTRACT: Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In p... more ABSTRACT: Glimiperide, a third-generation sulfonylurea is poorly soluble anti-diabetic drug. In preformulation study solid dispersions by solvent evaporation technique were prepared to enhance solubility. Different ratios of PEG 6000 to Glimperide were taken for solid dispersion. The Films of Glimepiride solid dispersion equivalent to 2mg Glimiperide , were developed by solvent casting method using different Polymers, HPMC K4M, Sodium CMC, carbopol 971P and polyox. The prepared mucoadhesive buccal patches were evaluated for Swelling index, Residence time, Folding endurance, Tensile strength and Mucoadhesive strength. In vitro release was carried out in simulated saliva solution using modified USP type II apparatus at 50 rpm. Ex vivo release studies were performed with few selected batches and its results along with evaluation parameter were taken in to account to select optimized batch. The release of Glimepiride from developed formulations was found to be fickian diffusion controll...
Atorvastatin calcium is the drug used for treating hypercholesterolemia.Microemulsions are used a... more Atorvastatin calcium is the drug used for treating hypercholesterolemia.Microemulsions are used as edge as potential drug deliveryvehicles because of their thermodynamic stability, reversibility,simple manufacturing, and scale up feasibility, and do not requireany special equipment. Microemulsionbased tablet of atorvastatin calcium was formulated using avicel 101 as career and aerosil as coating material. A32 full factorial design was carried out to optimise oil: smix ratio and % SSG for the formulation of tablet. Regression analysis was carried out for dependent variable and full and reduced polynomial equations ware generated for each variable. The response plot and counter plot were prepared for each response to check effect of each variable on response. Using check point batch the polynomial equations were validated and optimised batch were formulated using extensive grid search on overlay counter plot and polynomial equation. The optimised formulation was evaluated for flow property, hardness, friability, disintegration time, emulsification time, and invitro drug release. Drug release kinetic of optimised batch showed fickian diffusion type drug release. A stability study and comparison study with marketed formulation was carried out on optimise formulation.