Pharmacopoeial Standards and Specifications for Pharmaceutical Aerosols: In-Process and Finished Products Quality Control Tests (original) (raw)
Related papers
Quality control and testing evaluation of pharmaceutical aerosols
2020
12.8 Stability testing of aerosol products: International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guideline 606 12.9 Pharmacokinetic assessment and biological fate of aerosol delivered drugs 607 12.10 Bioavailability and bioequivalence studies of aerosol: Food and Drug Administration perspective 608
EXCIPIENTS AND ITS VARIATION IN PHARMACEUTICAL AEROSOL FORMULATION: A REVIEW
Innovat International Journal of Medical & Pharmaceutical Sciences, 2016
An aerosol can have variations in formulation as per the area of application and intention of use. In short aerosol formulations are the best NDDS for dispensing Active Pharmaceutical Ingredients (API's) to the systemic circulation as well as faster local action as compared to OSD. As this dosage form is applied topically, it does not affect the major organs of the body. It has been concluded that it does not show or shows minimum hypersensitivity to locally applied area. It shows best bioavailability as compared to the OSD & desired pharmacological effect. Now a days, new excipients are being used to used get the better formulation efficacy and for batter patient's compliance. According to the formulation to be processed, we should use specific excipients as conformed by the assay procedure in respective furmularary or pharmacopoeia. From various excipients like colorants, disintigrants, antiadherants, lubricants, sweeteners, binders, flavourin agents, glidants, sorbents, preservatives and vehicles, various dosage forms were formulated as per target and bioavailability. The present review is based on the excipients used in topical pharmaceutical aerosols and its variations.
Modification of Apremilast from Pills to Aerosol a Future Concept
International Journal of Environmental Research and Public Health, 2021
Background: Inhaled drugs have been available in the market for several years and for several diseases. Drugs for chronic obstructive pulmonary disease, cystic fibrosis, and diabetes have been used for several years. In the field of drug modification, these drugs range from tablets to aerosol. Methods: Milling as used to break down the tablets to powder and nebulisers are used to produce aerosol droplets. A mastersizer was used to measure the mass median aerodynamic diameter of the aerosol droplets. Results: Apremilast produced mmad diameters (2.43 μm) without any statistical difference between the different jet-nebulizers. The residual cup B contributed to greater mmad diameters as the 95% interval of mean values, based on those the ANOVA mean square clearly indicated, followed by cups C and F. The previous interval plot is much better clarified when the interaction means between drug and residual cap are plotted. The residual cups B, C and F produce mmad between (2.0–3.2). Conclus...
Aerosol drug delivery: developments in device design and clinical use
The Lancet, 2011
Aerosolised drugs are prescribed for use in a range of inhaler devices and systems. Delivering drugs by inhalation requires a formulation that can be successfully aerosolised and a delivery system that produces a useful aerosol of the drug; the particles or droplets need to be of suffi cient size and mass to be carried to the distal lung or deposited on proximal airways to give rise to a therapeutic eff ect. Patients and caregivers must use and maintain these aerosol drug delivery devices correctly. In recent years, several technical innovations have led to aerosol drug delivery devices with effi cient drug delivery and with novel features that take into account factors such as dose tracking, portability, materials of manufacture, breath actuation, the interface with the patient, combination therapies, and systemic delivery. These changes have improved performance in all four categories of devices: metered dose inhalers, spacers and holding chambers, dry powder inhalers, and nebulisers. Additionally, several therapies usually given by injection are now prescribed as aerosols for use in a range of drug delivery devices. In this Review, we discuss recent developments in the design and clinical use of aerosol devices over the past 10-15 years with an emphasis on the treatment of respiratory disorders.
Aerosols for systemic treatment
Lung, 1990
The development of a new group of drugs (polypeptides) have recently increased the interest of alternative administration to the enteral route because of its proteolytic activity and the catabolism of the "first-pass effect." Aside from the "needle," the administration in the respiratory tract via aerosol is the method with the best efficiency. But several problems prohibited its spreading: (1) the accuracy and the reproducibility of the inhaled dose (range ca. 1:4); (2) the small amount of inhaled drug in relation to the dose in the aerosol delivery system (range ca. 1%-10%); (3) the fear of allergic reactions of the respiratory system; (4) the variability of the drug transport into the systemic circulation. New approaches and data raise hopes in reducing the problems: (1) aerosol delivery systems with defined particle spectrum and storage systems; slow vital capacity inhaling maneuver; (2) delivery systems that nebulizes nearly the total amount of drug; (3) all studies with the inhalation application of insulin, heparin, ergotamin, ribavirin, aminoglycosides, and "cigarette smoke" do not reveal any relevant allergic reaction; (4) many studies were performed in the last 10 years on the influence of substances and especially of diseases on the transport of molecules through the respiratory tract. Only a few of them are relevant (exogen allergic alveolitis, active sarcoidosis, active smoking). Aerosols for systemic drug treatment seems to be a gained alternative to the "syringe."
International Journal of Pharmaceutics, 1995
Micellar solubilisation was used to enhance the solubility of salbutamol (SB) and triamcinolone acetonide (TAA) in chlorofluorocarbon solvents with the aim of formulating solution metered dose inhaler (MDI) products of these drugs. Stable, isotropic solutions of soya phosphatidylcholine (SPC) were obtained in trichlorotrifluoroethane (P113) and a 30:70 mixture of trichlorofluoromethane (Pll) and dichlorodifluoromethane (P12) containing water at a maximum level of R (tool water/mol SPC) = 4. The solubility of SB and TAA in both the non-pressurised solvent (Pl13) and the pressurised mixture (Pll/P12) increased proportionately with SPC concentration but was reduced on increasing values of R. The incorporation of a charged lipid, dicetyl phosphate, into the micellar structure promoted the solubilisation of SB in both solvent systems. In SPC solutions, the optimal solubility of either drug was achieved at R value of 0.9. Solution MDI formulations of SB and TAA gave reproducible shot potency throughout the pack-life, comparable to the performance of commercially available suspension products (SB, Ventolin; TAA, Azmacort). In contrast to suspension systems, however, there was no loss of potency in the first spray actuated after storage with SB solution MDIs. The respirable fraction (RF) of drug emitted from solution MDIs was significantly increased by altering the orifice diameter of the actuator. These studies confirmed that the highest RF values (in excess of those achieved with suspension products) were achieved when the MDIs were fired through an actuator with the smallest (0.25 ram) orifice.
International Journal of Research -GRANTHAALAYAH, 2020
Most of the inhalation products in the market use metered dose inhaler (MDI) technology or dry powder inhaler (DPI) technology. MDIs use propellant to deliver desired dose of liquid formulation in aerosol form. DPI contains active in fine particulate form embedded onto an inert carrier. In both cases, amount of drug dispensed from the device reaching the lungs is dependent upon drug product characteristics as well as formulation-device relationship. Hence, in addition to particle size, aerodynamic distribution of the drug upon delivery by the device plays an important role in determining amount of drug reaching the lungs. Therefore particle size characterization is an important tool in determining the extent of drug delivery from the metered dose inhaler. Aerodynamic particle size distribution is frequently determined by use of cascade impactors and data so generated is accepted by regulatory agencies as a tool for predicting efficacy of MDIs and DPIs. This review discusses principl...
Mixing and compatibility guide for commonly used aerosolized medications
American Journal of Health-System Pharmacy, 2010
Purpose. A mixing and compatibility guide for commonly used aerosolized medications was developed. Summary. Compatibility guides for injectable drugs are available as a reference for pharmacists, nurses, and medical personnel. These charts are commonly used in hospitals and other health care institutions and provide a quick, easy reference for compatibility of frequently used intravenous medications. Respiratory therapists are frequently directed to administer various aerosolized medications and are often faced with the challenge of uncertain compatibility of these drugs when mixed together. However, there appear to be limited data regarding the compatibility of these aerosolized admixtures. After a careful review of the literature, a compatibility chart was developed that should provide significant value to pharmacists, nurses,
Aerosolization Performance of Jet Nebulizers and Biopharmaceutical Aspects
Pharmaceutics
In this work, 13 jet nebulizers, some of which in different configurations, were investigated in order to identify the biopharmaceutical constraints related to the quality attributes of the medicinal products, which affect their safety, efficiency, compliance, and effectiveness. The aerosolization parameters, including the aerosol output, aerosol output rate, mass median aerodynamic diameter, and fine particle fraction, were determined according to the European Standard EN 13544-1, using sodium fluoride as a reference formulation. A comparison between the aerosol output nebulization time and the fine particle fraction displayed a correlation between the aerosol quality and the nebulization rate. Indeed, the quality of the nebulization significantly increased when the rate of aerosol emission was reduced. Moreover, the performance of the nebulizers was analyzed in terms of respirable delivered dose and respirable dose delivery rate, which characterize nebulization as the rate and amo...