Drug Stability

A special issue of Pharmaceutics (ISSN 1999-4923).

Deadline for manuscript submissions: closed (31 May 2017) | Viewed by 14386

Special Issue Editor

PHARMACY, College of Medicine and Dentistry, James Cook University, Douglas, Townsville, QLD 4811, Australia
Interests: photo-stability; in-use drug stability; drug regulation and quality; falsified medicines, formulation and excipients
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Stability is a term widely used to designate the chemical and physical integrity of a drug dosage form and its ability to maintain protection against exposure to environmental conditions, such as light, air (oxygen) and heat throughout its shelf-life. However, this field of research has expanded over recent years to include the effects on stability of storage and transport, repackaging and importantly the potential clinical outcomes for patients who may be exposed to toxic effects of drug degradants, with an example including photosensitivity reactions as a result of exposure to light after taking a drug susceptible to photo degradation. Drug stability has also become an important area of research for analytical chemists in the development of stability-indicating methods of analysis, and is critical in drug regulation and quality as regulators especially in developing countries focus their attention on counterfeit medicines. The aim of compiling this Special Issue of Pharmaceutics on the topic of “Drug Stability” is to draw together experts with knowledge in the field across this widely diverse area including chemists, pharmaceutical scientists and clinicians, who are engaged in contemporary pure and applied research to solve the challenges of delivering stable and quality drug dosage forms to all populations. Submissions (original papers and reviews) that contribute to understanding and applications of relevance for Drug Stability are welcomed for this Special Issue.

Prof. Dr. Beverley D. Glass
Guest Editor

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Keywords

  • Drug stability
  • Photo stability
  • Drug degradation
  • In-use stability
  • Drug stabilization

Published Papers (2 papers)

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Research

4780 KiB  
Article
Stability Study of Sunscreens with Free and Encapsulated UV Filters Contained in Plastic Packaging
by Benedetta Briasco, Priscilla Capra, Barbara Mannucci and Paola Perugini
Pharmaceutics 2017, 9(2), 19; https://doi.org/10.3390/pharmaceutics9020019 - 31 May 2017
Cited by 13 | Viewed by 6414
Abstract
Sunscreens play a fundamental role in skin cancer prevention and in protection against photo-aging. UV filters are often photo-unstable, especially in relation to their vehicles and, being lipophilic substances, they are able to interact with plastic packaging. Finally, UV filter stability can be [...] Read more.
Sunscreens play a fundamental role in skin cancer prevention and in protection against photo-aging. UV filters are often photo-unstable, especially in relation to their vehicles and, being lipophilic substances, they are able to interact with plastic packaging. Finally, UV filter stability can be significantly affected by the routine use of the product at high temperatures. This work aims to study the stability of sunscreen formulations in polyethylene packaging. Butyl methoxydibenzoylmethane and octocrylene, both in a free form and as encapsulated filters were chosen as UV filters. Stability evaluations were performed both in the packaging and on the formulations. Moreover, a further two non-destructive techniques, near-infrared (NIR) spectroscopy and a multiple light scattering technique, were also used to evaluate the stability of the formulation. Results demonstrated clearly that all of the pack underwent significant changes in its elastic/plastic behavior and in external color after solar irradiation. From the evaluation of the extractable profile of untreated and treated packaging material an absorption of 2-phenoxyethanol and octocrylene were shown. In conclusion, the results highlighted clearly that a reduction of the UV filter in the formulation packed in high-density polyethylene/low-density polyethylene (HDPE/LDPE) material can occur over time, reducing the protective effect of the product when applied to the skin. Full article
(This article belongs to the Special Issue Drug Stability)
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Article
A Robust Liquid Chromatographic Method for Confirmation of Drug Stability of Azithromycin in Bulk Samples, Tablets and Suspensions
by Alex O. Okaru, Kennedy O. Abuga, Franco N. Kamau, Stanley N. Ndwigah and Dirk W. Lachenmeier
Pharmaceutics 2017, 9(1), 11; https://doi.org/10.3390/pharmaceutics9010011 - 24 Feb 2017
Cited by 3 | Viewed by 6598
Abstract
A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The optimum chromatographic conditions for separation were established as a mobile phase comprised of acetonitrile-0.1 M KH [...] Read more.
A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The optimum chromatographic conditions for separation were established as a mobile phase comprised of acetonitrile-0.1 M KH2PO4 pH 6.5–0.1 M tetrabutyl ammonium hydroxide pH 6.5-water (25:15:1:59 v/v/v/v) delivered at a flow rate of 1.0 mL/min. The stationary phase consisted of reverse-phase XTerra® (250 mm × 4.6 mm i.d., 5 µm particle size) maintained at a temperature of 43 °C with a UV detection at 215 nm. The method was found to be linear in the range 50%–150% (r2 = 0.997). The limits of detection and quantification were found to be 0.02% (20 µg) and 0.078% (78 µg), respectively, with a 100.7% recovery of azithromycin. Degradation products of azithromycin in acidic and oxidative environments at 37 °C were resolved from the active pharmaceutical ingredient and thus the method is fit for the purpose of drug stability confirmation. Full article
(This article belongs to the Special Issue Drug Stability)
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