Solubility, Dissolution and Bioavailability
Solubility, Dissolution and Bioavailability: Three Distinct Concepts in Oral Solid Dosage Form Development A significant proportion of new drug candidates present limited aqueous solubility. This is a well-documented formulation challenge, particularly for oral solid dosage forms, where the performance of the final product depends not only on the API itself, but also on the way […]
Pharmaceutical Lactose in Oral Solid Dosage Forms
Pharmaceutical Lactose in Oral Solid Dosage Forms: Grade Selection, Functional Contribution and Development Considerations In oral solid dosage forms, lactose is often described as a filler. This description is accurate, but it can be incomplete. Depending on its grade, particle size distribution and physicochemical characteristics, pharmaceutical lactose can contribute to several formulation parameters, including blend […]
Nitrites & Nitrosamines in Pharmaceutical Excipient
Since the Valsartan crisis in 2018, attention has shifted to an impurity that had long remained under the radar: nitrosamines. These potent genotoxic impurities, classified as probable human carcinogens, are not the result of isolated external contamination but a byproduct of specific chemical conditions during the manufacturing process. [1] Following global recall and media coverage, […]
Are Endotoxins a Hidden Risk in Pharmaceutical-Grade Lactose?
Pharmaceutical Excipient Safety: Exploring Endotoxin Risks in Lactose : A Perspective from Lactalis Ingredients Pharma At Lactalis Ingredients Pharma, we specialize in milled and sieved pharmaceutical lactose, intended for oral solid dosage forms pharmaceutical applications. While we do not produce lactose for inhalation, the topic of endotoxin risks in pharmaceutical lactose remains highly relevant for […]
Why is lactose still a useful excipient in formulations?
Contrary to popular belief, it is not generally necessary to remove lactose from formulations. The quantities added are extremely small and have no impact on consumers. In pharmaceuticals, lactose is considered as a safe excipient, with limited negative interactions with drugs. A medicine, tablet or capsule, contains between 0,1 g to 0,2 g of lactose, […]
Nitrosamines Contamination in Pharmaceutical Excipients: Risks & Prevention
Nitrosamines, probable human carcinogens, have raised concerns in the pharmaceutical industry. While regulations focus on active ingredients, excipients can also be a source of contamination. Discover the latest detection methods, regulatory updates, and how Lactalis Ingredients Pharma ensures compliance. The Rising Challenge of Nitrosamines Contamination in Excipients Could pharmaceutical excipients be a hidden source of […]
Lactose intolerance in pharmaceuticals: is it really a matter to consider?
Lactose, a disaccharide composed of galactose and glucose, is the main sugar derived from milk. Lactose is present in a wide range of food products but is also used in the pharmaceutical industry as an excipient. Once ingested, the digestion of the lactose normally consists in 3 majors steps: The inability of the body to […]
