Pharma Blog
Formulation of the Pharmaceutical Enzymes
Formulating enzymes products presents unique challenges in maintaining stability, activity, and functionality. Here are the key areas to consider: Enzyme Stability Enzyme Activity Formulation Compatibility Preparation and Mixing Compression (for Tablets) Storage Stability Regulatory and Quality Assurance Successfully formulating enzyme products involves strategic formulation, strict process controls, and comprehensive testing ... Read More
TIP Speed Calculation for RMG Process Scale-Up
Scaling up in pharmaceutical manufacturing, especially with Rapid Mixer Granulators (RMG), requires careful attention to “Motion similarity between lab RMG and production Large RMG “, particularly in maintaining consistent “tip speed”. Here’s why this is crucial:Tip speed—the speed at the edge of the rotating impeller directly affects mixing efficiency and ... Read More
Deviation Management and Root Cause Analysis
In the life sciences industry, maintaining the highest quality standards is non-negotiable. Deviations, or departures from established procedures, are inevitable, but how we manage them makes all the difference. Here’s why Deviation Management and Root Cause Analysis (RCA) are pivotal: Ensuring Compliance and Safety: Systematic Investigation: Preventative Measures: Continuous Improvement: ... Read More
Surfactants in Dissolution
We have many factors to consider when making a dissolution method. What apparatus, speed, filter choice, etc. Of these factors, the one I get the most questions about is media selection – especially surfactants in media selection. So, what is a surfactant and why do we use them? What do ... Read More
How Do Regulated Companies Balance Quality and Compliance
First of all quality and compliance are related but distinct concepts. Quality refers to the degree to which a product or service meets or exceeds customer expectations. It’s about delivering value and ensuring satisfaction. Compliance, on the other hand, involves adhering to laws, regulations, standards, and guidelines set by external ... Read More
FDA Queries Related to Drug Substances in the CMC
There are few common queries related to drug substances in the CMC (Chemistry, Manufacturing, and Controls) section. Here’s an example: 3.2. S DRUG SUBSTANCE3.2. S.1 General Information 3.2. S.1.1: Nomenclature SectionQueries: 1. USAN, BAN, IUPAC, names, CAS not provided until. 3.2. S.1.2: Structure Section Queries:Stereochemistry, Isomerism structure and discussion on ... Read More
Types of Drug Antagonism
The several types of antagonism can be classified as follows: Chemical Antagonism Chemical antagonism involves a direct chemical interaction between the agonist and antagonist in such a way as to render the agonist pharmacologically inactive. A good example is the use of chelating agents to assist in the biological inactivation ... Read More
Factors Affecting Rate of Gastrointestinal Absorption
In addition to the lipid–water partition coefficient of drugs, local blood flow, and intestinal surface area, other factors may affect absorption from the gastrointestinal tract. Gastric Emptying Time The rate of gastric emptying markedly influences the rate at which drugs are absorbed, whether they are acids, bases, or neutral substances. ... Read More
Absorption of Drugs from Alimentary Tract
Oral Cavity and Sublingual Absorption In contrast to absorption from the stomach and intestine, drugs absorbed from the oral cavity enter the general circulation directly. Although the surface area of the oral cavity is small, absorption can be rapid if the drug has a high lipid–water partition coefficient and therefore ... Read More
Types of Drug Receptor Binding
Biological receptors are capable of combining with drugs in a number of ways, and the forces that attract the drug to its receptor must be sufficiently strong and long-lasting to permit the initiation of the sequence of events that ends with the biological response. Those forces are chemical bonds, and ... Read More
Prednisolone | Drug Digest
Prednisolone is a synthetic glucocorticoid, which works by mimicking the effects of cortisol, a naturally occurring hormone produced by the adrenal glands. It acts on the glucocorticoid receptor, affecting various cellular processes, including: Reducing inflammation by inhibiting the release of inflammatory mediators such as prostaglandins and leukotrienes. Suppressing the immune ... Read More