Manufacturing, Topical Drugs

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

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.

Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.

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

Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.

The contract development and manufacturing organization will discuss its capabilities in topical drug products at CPhI North America, taking place April 24–26, 2018 in Philadelphia, PA.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

Tapemark, a full-service CDMO specializing in transdermal, oral thin film, and topical drug-delivery technologies, is exhibiting at CPhI.

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

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

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

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

Consider these tools and strategies for optimizing the manufacturing process.

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.

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.