Manufacturing, Topical Drugs

Topical Formulations in Pharma–Balancing Form and Function

May 03, 2022

Ongoing advances in technology and modeling techniques are helping to align all the objectives of both drug manufacturers and patients.

MedPharm Opens Manufacturing Facility for Topical and Transdermal Drug Products

June 04, 2021

MedPharm’s new facility for process development and small-scale manufacturing is in North Carolina, near its existing R&D center.

Identifying the Structure of an Unknown Impurity in a Topical Gel

April 06, 2020

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.

Challenges in Clinical Manufacturing for Topical Drugs

March 02, 2020

Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.

FDA Accepts MC2 Therapeutics’ NDA for Topical Plaque Psoriasis Treatment

November 26, 2019

The new treatment is the first cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis.

Getting in Touch with New Guidance on Topical Products

October 02, 2019

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

Process Development Best Practices for Topical Drug Products

February 02, 2019

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.

Developing and Manufacturing Transdermal Patches

December 02, 2018

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.

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

September 01, 2018

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

FDA Approves First Drug for Rare Eye Disease

August 24, 2018

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.