Development

Editor of Pharmaceutical Technology Europe

Articles

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

Delivering the Goods

The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.

FDA Publishes Guidance on Transdermal and Topical Delivery Systems

Marc Brown, PhD, is chief scientific officer and co-founder of MedPharm.

Sarah Pratt is chief operating officer at MedPharm.

Christopher Harrison, is head of Process Development and Manufacture at MedPharm.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

Process Development Best Practices for Topical Drug Products

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Virpax’s Patch-in-a-Can technology delivers pain medication using a metered-dose spray film.

Spray Film Provides Alternative to Patches

Medherant has announced positive results from two Phase I trials evaluating its transdermal drug delivery patch loaded with ibuprofen.

Medherant Reveals Positive Phase I Results of Transdermal Patch

Funding from Innovate UK will be used by Medherant to support manufacture of transdermal patches for clinical trials.

Medherant Receives Grant from Innovate UK for Transdermal Patch Manufacturing

QbD Strategies to Secure the Scale-Up of Semi-Solid Topical Formulations

Paul Kippax is product manager at Malvern Instruments.

Jennifer Burt is applications specialist at Malvern Panalytical.

Carolyn O'Grady is UK applications manager at Malvern Panalytical.

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary. 

Testing Topicals: Analytical Strategies for the In-Vitro Demonstration of Bioequivalence

Jon Lenn, PhD, is senior vice-president for MedPharm’s US operations. 

The human skin protects the body from physical, mechanical, and chemical insults while preventing endogenous water loss. This function is predominantly achieved by a thin (10–30 µm) cornified outermost layer-the stratum corneum (SC)-generated through terminal differentiation of the basal epidermal keratinocytes. The stratum corneum protects the human body, but also severely limits drug delivery into and across the skin.

A Perspective on the Topical Delivery of Macromolecules

Birthe Herziger is a PhD student at Freie UniversitÃ¤t Berlin.

Fred Monsuur is excipient development manager at Grace Materials Technologies, Germany.

Sung Min Pyo is a post-doctoral research scientist, at Freie UniversitÃ¤t Berlin, Tel.: +49 30 838 507 03; pyo.sungmin@fu-berlin.de. 

Drugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.

Formulation and Drug Delivery, Topical Drugs