Formulation and Process Development Articles

Purpose: The main aim of the present work was to prepare matrix sustained release pellets of poorly soluble drugs with satisfactory dissolution profiles. Methods: Nimodipine (NMD) was selected as a model drug.

Purpose: Irinotecan hydrochloride (CPT-11) frequently develops early diarrhea, together with late diarrhea in patients. The present study was designed to determine whether glutamine (Gln) or alkaline ionized water (Alkali) could prevent and/or relieve late diarrhea induced by CPT-11 in Gunn rats, which lack the hepatic glucuronyltransferase activity.

Purpose: To prepare chitosan-modified paclitaxel-loaded PLGA nanoparticles and evaluate their cytotoxicity in vitro. Method: The parameters of the emulsion solvent diffusion process were optimized.

Purpose:To investigate the effect of various vehicles and skin permeation enhancers on the in vitro skin permeation and in vivo skin absorption of ondansetron hydrochloride (OND) and to investigate the possible mechanism of this enhancement. Method: OND solutions were prepared by dissolving OND in isopropyl alcohol or propylene glycol and various permeation enhancers.

The National Institute for Pharmaceutical Technology and Education (NIPTE) was formed in June 2007 as an independent nonprofit organization by 11 major US universities.

Driven by greater global competition and the growing impact of information technology, the pharmaceutical industry faces a need to improve its performance. Speed to market, product quality, regulatory compliance, cost reduction, waste, and cycle time are among the concerns that must be addressed in a systematic, focused, and sustainable manner.

The Office of Generic Drugs (OGD) fully implemented Question-based Review (QbR) in 2007 with the broad goal of encouraging sponsors to include quality-by-design (QbD) principles in their product and process development and to communicate this knowledge in their submissions.

The US Food and Drug Administration's Office of Generic Drugs (OGD) and the Generic Pharmaceutical Association (GPhA) held a two-day workshop in June 2009 in Maryland, on pharmaceutical quality by design (QbD) for generic-drug products.

In August 2002, the US Food and Drug Administration issued a pronouncement on pharmaceutical manufacturing called Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (1). The initiative encouraged the pharmaceutical industry to adopt concepts related to modern quality techniques and state-of-the art processing and paved the way for new thinking about pharmaceutical manufacturing.

In the United States, drug products are deemed therapeutically equivalent if they meet the regulatory criteria of pharmaceutical equivalence and bioequivalence (1). Designation of therapeutic equivalence dictates interchangeability between a generic drug and its reference-listed drug (pioneer) product.