Placebo Manufacturing for Clinical Trials
A blinded, placebo-controlled clinical trial requires the development, manufacture, and packaging of the placebo formulation. For oral solid dosage forms such as tablets and capsules, this requires matching the size, shape, and color of the product and at least approximately matching the weight. For liquids, powders, chewable tablets, and orally disintegrating tablets (ODTs), this requires […]
Mutagenic Impurities in a 505(b)(2): Why a Known API Does Not Mean Known Impurities
Few issues can quietly derail a 505(b)(2) NDA like a mutagenic impurity question. It may begin as a QSAR flag, a structural alert on a degradant, or a late request for toxicological support. Because the work can involve method development, validation, testing, and sometimes an additional study, a question raised in month six can still […]
Analytical Methodology: Validation, Verification, or Qualification – Choosing the Right Approach
Validation, verification, and qualification are often used interchangeably in pharmaceutical testing, but each has their own distinct meanings and all serve different purposes. Getting the test right is just as important in pharmaceutical manufacturing as making the drug. If the analytical method you go with is flawed, every result that follows is questionable. Beyond those […]
Analytical Testing for Peptide Formulations
Peptides are commonly used to treat diabetes, obesity, and metabolic disorders. These days, they are also being explored for cancer therapy because they can target specific cells and pathways in the body. Many drugs, including GLP-1 receptor agonists like Semaglutide and Tirzepatide, are examples of peptide-based treatments that have really shown a lot of potential. With […]
What Is HPLC and Why Is It So Commonly Used for Pharmaceutical and Dietary Supplement QC Testing?
HPLC is an advanced sorting tool for QC testing; it allows manufacturers to verify the quality of their products with high precision. It also helps ensure that products comply with cGMP and meet the regulatory requirements set by agencies like the FDA. How Does HPLC Work? HPLC separates substances in a liquid sample based on […]
What is Content Uniformity and Why is it Important in Oral Solid Dose (OSD) Manufacturing?
Content uniformity (CU) is a quality control measure in pharmaceutical manufacturing that ensures the active pharmaceutical ingredient (API) is evenly distributed within each dosage unit. Content uniformity is a critical to quality attribute (CQA) of a pharmaceutical product that ensures patient safety and drug efficacy. This is particularly important for formulations with very low dosage […]
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 […]