A Rapid Method for the determination of Dehydrated alcohol (Ethanol) content in Clobetasol propionate foam by Non-polar Capillary Gas chromatography

Clobeatsol propionate foam is a topical class 1 corticosteroid used to treat itching and inflammatory arthritis on the skin occurred by allergic reactions, psoriasis and eczema. In the pharmaceutical aerosol products, Dehydrated alcohol (Ethanol) is the primary ingredient and its concentration level in the formulation composition plays a significant role in the regulation of aerosol rate, droplet shape and particle size. It can also act as solubilizer for active pharmaceutical ingredient, topical disinfectant and skin permeation enhancer. Hence accurate assay of Ethanol is a crucial quality control component. A simple and rapid gas chromatography method was developed to quantify Ethanol content in Clobetasol propionate foam drug product using fused silica glass tube non-polar capillary column (HP-5, 30 m, 0.53 mm, 1.5 µm). Ethanol in the sample was diluted with methanol after adding suitable amount of internal standard, the isopropyl alcohol solution.The developed method is precise, linear and accurate in the range of 5 mg/mL to 15 mg/mL of nominal concentration of ethanol i.e. 10 mg/mL . The presented method has an advantage of a very quick gas chromatographic separation (less than 16 min) and therefore is highly suitable for in-process and stability analysis of Ethanol content in Clobetasol propionate foam drug product.

A Concise Overview on Recent Advances in Pharmaceutical Aerosols and Their Commercial Applications

Background: Localized drug delivery to the respiratory system has become an increasingly successful and essential treatment strategy for several pulmonary diseases, including asthma, chronic abstractive disease, pneumonia, bronchitis, and cystic fibrosis. The rising incidence of respiratory diseases is a significant factor driving the worldwide market for respiratory inhaler devices. Objective: The objective of this article is to present various aspects of pharmaceutical aerosols, including their types, components, fundamentals, in-process and finished product quality control tests based on pharmacopeial standards and specifications, and commercial utility considering the pharmaceutical aerosol dosage forms that have been patented from 2000 to 2020, along with a list of marketed pharmaceutical products. Method: Aerosol, collectively referred to as a pressurized device, operates by triggering an appropriate valve system with a continuous or metered dosage of tiny mist spray. It is used not only in the treatment of asthma and chronic obstructive pulmonary disease but also in the treatment of cancer, diabetes, migraine, angina pectoris, acute lung injury, bone disorders, tuberculosis, and many more. A multitude of different variables, including types and properties of propellants, active substances, containers, valves, actuators, spray patterns, valve crimping efficiency, and particle size of the aerosols, influence the therapeutic effectiveness of pharmaceutical aerosols. Conclusion: Based on the current findings, distinct characteristics such as the elimination of firstpass metabolism, quick drug absorption, ease of therapy termination, as well as a larger surface area have attributed to the success of pharmaceutical aerosols.

Nebulizer therapy for lung diseases

The article presents data on the use of nebulizer therapy for major respiratory diseases: chronic obstructive pulmonary disease (COPD), bronchial asthma. The conditions for using aerosol-producing devices for new COVID-19 coronavirus infection, in the hospital and at home are also given. Historical aspects of the creation and use of devices for nebulizer therapy are considered. A differentiated approach is given when choosing an inhaler depending on the clinical situation, taking into account the need to use devices with a high level of precipitated fine particle fraction of the pharmaceutical aerosol, external minimal losses, with a reduced inhalation time and an economical treatment regime with optimal medication consumption. These advantages are inherent to nebulizers of the company PARI: PARI BOY SX and VELOX®. In patients with COPD, options for using nebulizer therapy in a stable state and in exacerbation are considered. It is emphasized that the inhaled route of administration of drugs provides direct penetration of the drug into the respiratory tract and, thus, contributes to a more effective drug effect. In addition, the inhalation route of administration reduces the potential risk of side effects. In patients with bronchial asthma, priority is given to the appointment of inhaled corticosteroids and β2-agonists in exacerbation. Data on the main types of devices, their advantages and disadvantages are provided. In conclusion, it is concluded that nebulizer therapy is a modern way to deliver the drug to the respiratory tract. In a number of clinical situations, the use of nebulizers is the only way to deliver the drug to a pathological focus. The use of nebulizers significantly expands the treatment options for patients with COPD and BA, reduces the need for hospitalization, and prevents the development of severe exacerbations.