What is Freeze thaw (Thermal cycling) study?
A freeze-thaw study is a type of stress test performed on liquid formulations to evaluate how finished dosage forms react to repeated cycles of freezing and thawing. For example, when pharmaceutical suspensions formulations or emulsions freeze, they lose their structural characteristics that maintain their properties. Upon thawing, the drug substance may not redisperse properly or may […]
What is In-Use Stability?
An in-use stability study is performed to evaluate the chemical, physical, microbiological, and functional integrity of a pharmaceutical product after it has been opened or used but before it expires. This test is used to establish the shelf life and storage condition recommendations for pharmaceutical products after the primary packaging is opened. For example, oral […]
Does your dosage form need to be sterile? Key differences between sterile and non-sterile dosage forms
Whether a dosage form must be sterile prior to administration depends on its route of administration. Parenteral products such as injectable formulations, ophthalmic formulations, otic formulations, and aqueous inhalation products must be sterile prior to use. Oral solid dosage (OSD) and oral liquids, topical, vaginal and anal suppositories on the other hand need not be […]
Stability Testing for Pharmaceutical Drug Products
Establishing shelf life for medicines is a requirement prior to commercializing medicine or initiating clinical trials. Requirements vary for approved pharmaceutical products, compounded medicine, or dietary supplements. Stability testing is performed on pharmaceutical products during drug development and through the life of the product to establish and verify the shelf life of the product. Packaged […]
Frequently Asked Question: Dissolution testing
Dissolution testing of pharmaceutical drug products is one of the most important tools during drug development and for quality assurance during quality control (QC) release testing. This testing is mandatory for all oral solid dose, oral semi solid dose, and oral suspension products. It is not required for drugs that are already in solution such […]
From R&D to Quality Control (QC): Developing QC-Friendly Analytical Methods
Quality control is an integral part of the drug development process, and the quality of analysis can make a difference in a drug product’s safety and efficacy. QC-friendly analytical methods are simple to operate and require minimum sample preparation. They are robust, reliable, and efficient for routine analytical tests. Furthermore, the analytical tests run by […]
Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective Drug Development
Drug development is a complex and highly regulated process that necessitates ongoing validation to ensure drug product safety and efficacy. A phase appropriate method validation technique is applied at each step of drug development; with flexibility being provided in the initial stages where the methods can change. As the phases advance toward clinical use, strict […]