Manufacturing

Articles

The Transform hydrate-able film from Lubrizol LifeSciences is compatible with a range of APIs.

Lubrizol Introduces Topical Film

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Katherine Ulman is a Global Regulatory Compliance Manager at Dow Corning.

Phyllis Walsh is a senior compendial manager at Schering-Plough Corporation in Kenilworth, New Jersey.

EHS specialist at Dow Corning Corporation, Auburn, MI

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Establishing Limits for Dermal Absorption of Elemental Impurities

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Advanced drug delivery technologies can increase efficacy and safety, extend patent lives, and provide competitive differentiation for biopharmaceuticals.

Drug Delivery Technologies Provide Growth Opportunities for Biopharmaceuticals

Consider these tools and strategies for optimizing the manufacturing process.

Challenges in Topical Drug Manufacturing

Kim Gaspar, PhD, is manager of quality assurance at Helix BioPharma.

Jinghui Shen, B. Eng., is an analytical chemist at Helix BioPharma.

John Docherty, M. Sc., is president and chief operating officer at Helix BioPharma.

Ravinderjit Batta, M. Pharm., is group leader of formulation development at Helix BioPharma.

Geriene LaBine, M. Sc., is head of quality control at Helix BioPharma.

Praveen Kumar, M. Pharm. and PhD, is vice-president of topical drug product development at Helix BioPharma, 301â111 Research Drive, Innovation Place, Saskatoon, Saskatchewan, Canada S7N 3R2, tel. 306.934.7471 ext 230, fax 306.934.7453.

Marianna Foldvari, D. Pharm. Sci. and PhD, is Canada research chair in bionanotechnology and nanomedicine and associate director of research and graduate studies at the School of Pharmacy, University of Waterloo, Ontario, Canada.

The authors describe a proprietary process for producing a stable, topical interferon alpha-2b formulation that can deliver large drug molecules into the skin or mucosa.

Stabilization of Interferon alpha-2b in a Topical Cream

David W. Osborne, PhD, is Chief Scientific Officer and Founder, Independent Derm Solutions, LLC, 4215 Creekside Court, Fort Collins, CO 80525.

This article summarizes the classification systems for topical liquid and semisolid dosage forms used for dermatological application and notes some differences between FDA and USP classification.

Manufacturing, Topical Drugs