Pharma Digests
Pharmaceutical Disintegrants and It’s Mechanism of Action
Croscarmellose Sodium(CCS) Crospovidone Sodium Starch Glycolate Microcrystalline Cellulose(MCC) Pre-Gelatinized Starch Low-Substituted Hydroxypropyl Cellulose(L-HPC) Ion Exchange Resins (e.g., Polacrilin Potassium) Read also:
Key Challenges in Bioequivalence (BE) Studies
Bioequivalence (BE) studies are the foundation of generic drug approvals, ensuring that alternative formulations provide the same therapeutic effect as the reference product. However, regulatory expectations and methodologies are evolving rapidly to address complex formulations and emerging technologies. Key Challenges in BE Studies Complex Generics & Locally Acting Drugs Highly ... Read More
Novel Polymers in Drug Delivery
From the precision of controlled drug release with Hydroxypropyl Methylcellulose (HPMC) to the sophistication of targeted delivery systems using Polyethylene Glycol (PEG), novel polymers are reshaping the landscape of drug development. Let’s dive into the realms of innovation and unlock the possibilities! Advantages of PLGA (Poly(lactic-co-glycolic acid)) Real-time Examples of ... Read More
One Product Development for Multiple Markets
Developing a single product for multiple markets requires careful planning to meet the regulatory requirements of each target region. Identify Target Markets & Regulatory Authorities Each country or region has its own regulatory body that sets guidelines for pharmaceutical products. Key regulatory agencies include: Each authority has different requirements for ... Read More
Permeability and Biowaivers | A Key Factor in Regulatory Justification
For obtaining a biowaiver based on permeability, regulatory authorities like USFDA, EMA, and WHO require a justification report that classifies the drug according to the Biopharmaceutics Classification System (BCS). This classification determines whether a drug is eligible for a biowaiver based on high solubility and high permeability (BCS Class I) ... Read More
Level III Biorelevant Media
At Level III of biorelevant media simulation, a comprehensive replication of the gastrointestinal (GI) tract environment includes factors such as luminal osmolality, pH range, buffer capacity using specific buffer ingredients, bile components, dietary lipid components, dietary proteins, increased viscosity (notably in the fed stomach and lower intestine), and the replication ... Read More
Level II Biorelevant Media
Developing accurate models of the gastrointestinal (GI) tract is paramount in pharmaceutical research to predict how drugs interact with the human body. Level II biorelevant media emerges as a sophisticated tool to mirror the intricate conditions within the GI system, playing a pivotal role in enhancing drug formulation and assessment. ... Read More
Level I Biorelevant Media
When studying drug dissolution in the gastrointestinal (GI) tract, simulating realistic physiological conditions is crucial for accurate results. Enter Level I biorelevant media – a novel approach to create in vitro environments that closely mimic luminal pH and buffer capacity in different regions of the GI tract. At Level I, ... Read More
Level 0 Biorelevant Media
Biorelevant media were initially proposed in 1998 to study the dissolution of poorly soluble drugs in the gastrointestinal (GI) tract. Over time, different media have been developed to mimic various parts of the GI tract in both fasted and fed states. For the fasted state, there are specific biorelevant media ... Read More
Teriparatide Injection’s Generic Approval and FDA Quality-Related Review
Introduction to Teriparatide and its Generic Approval Teriparatide, a peptide-based drug consisting of 34 amino acids with a molecular weight of 4117.8 daltons, is primarily indicated for treating osteoporosis. Its formulation comes as a clear solution in a multi-dose injector pen for subcutaneous injection. Teriparatide is administered daily in a ... Read More