Dosage Forms

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

Articles

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

Impact of Quality by Design on Topical Product Excipient Suppliers, Part I: A Drug Manufacturer's Perspective

Alex Slowey is Formulation Specialist at 3M Drug Delivery Systems Division, UK. Morley Street Loughborough Leicestershire LE11 1EP Tel. +44 (0)1509 613913 aslowey1@mmm.com

Understanding the components of a reference marketed pMDI is needed to develop a generic pMDI.

Reverse Engineering a Pressurized Metered Dose Inhaler

3M™ Intelligent Control Inhaler

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.

Aptar Pharma Forms Pact with BD to Develop Novel Autoinjector

Agnes Shanley is senior editor of Pharmaceutical Technology.

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.

Topical Formulation: Moving From Art to Science

Characterizing Microstructural Differences of Semisolid Topical Dosage Forms

Topical semi-solids, like creams, lotions and ointments are comprised of a complex mixture of microstructures or colloidal phases, frequently referred to as the Q3. These microstructures may include micelles, lamellar phases, polymer matrices, liquid crystalline and crystalline states of wax excipients, as well as the solid states of active pharmaceutical ingredients. Different topical medicated semi-solid formulations, spanning a range of treatment indications, reveal a variety of different microstructures.

Understanding the Role of Excipients in Topical Semi-Solid Microstructure and Critical Performance Parameters

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

FDA Adjusts Review Timeline to Keep Up with Orphan Drug Demand

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

Ibrutinib Receives Orphan Drug and Breakthrough Therapy Designation for cGVHD

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

Specialty Dosage Drugs