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What Is the FDA Orange Book, and Why Should Every Formulation Scientist Understand It?
For anyone working in pharmaceutical R&D, regulatory affairs, or generic drug development, the FDA Orange Book is not just a regulatory reference—it’s a strategic tool that can significantly influence the success of your product development. Officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is published by ... Read More
Determination of Dissolved CO2 in Soft Drinks
A Hands-On Experiment with Dissolved CO2 I’ve always wondered about the science behind the things we do every day. I recently set out to measure the ‘fizz’ in soft drinks by finding out how much CO2 is dissolved. This was a wonderful experiment of titration with sodium hydroxide. It wasn’t ... Read More
The Science Behind the Drug Potency
The science behind drug potency is far more complex than you think. If you’re in pharmaceuticals or biotechnology, you’ll frequently hear the term “potency.” But what exactly does it mean, and why is it important? What is Drug Potency? Potency refers to the amount (dose or concentration) of a drug ... Read More
Why Are Phosphate Buffers So Popular in HPLC?
If you work with HPLC chances are you’ve used phosphate buffers. But why phosphate? What makes them so widely trusted? Let’s find out why? 1. Excellent pH Control Phosphate has three dissociation constants (pKa) values: This allows effective buffering across a broad pH spectrum. This is essential for controlling the ... Read More
Incisions of Abdominal Surgery
1. Midline Incision 2. Paramedian Incision 3. Transverse Incision 4. Kocher Incision 5. McBurney Incision 6. Lanz Incision 7. Pfannenstiel Incision 8. Battle’s Incision 9. Rutherford-Morrison Incision These incisions are selected based on factors such as: Read also: Resource Person: Akmal K. Ishak
The Secrets of Good Peak Shape in HPLC
Achieving good peak shape in HPLC is essential for accurate quantitation, improved resolution, and extended column lifetime. A well-shaped peak is symmetrical, with a tailing factor of ~1.0, high efficiency, and narrow peak width. Key Factors Influencing Peak Shape Column Selection & Chemistry Silica Purity & Acidity: Specialized Phases: Mobile ... Read More
Fumigation in Pharmaceutical Industry
Fumigation is an important process in maintaining sterile conditions in pharmaceutical manufacturing areas. Here’s an overview of fumigation in sterile areas within the pharmaceutical industry: Purpose of Fumigation Common Fumigants Fumigation Process Steps Preparation: Sealing the Area: Application: Exposure Time: Ventilation: Safety Considerations Regulatory Compliance Documentation and Validation Read also: ... Read More
Critical Processing Parameters in the Fabrication of PLGA Microparticles
Introduction Poly(lactic-co-glycolic) acid (PLGA) microparticles have gained significant attention as controlled drug delivery systems. Despite their potential, the translation of these systems from research to FDA-approved products remains limited. A major challenge lies in understanding the critical processing parameters (CPPs) that influence their fabrication and scale-up. A recent study by ... Read More
Critical Material Attributes (CMAs) of Excipients
When focusing solely CMAs of excipients, the same principles of API apply. These attributes influence the performance and manufacturability of the final drug product and are critical for achieving consistency in pharmaceutical formulations. Critical Material Attributes of Excipients Physical Properties Particle Size Distribution (PSD): Bulk Density and Tap Density: Specific ... Read More
Alcohol Dose Dumping | A Critical Pharmaceutical Challenge
Introduction Alcohol dose dumping occurs when controlled-release formulations release their active ingredient rapidly in the presence of alcohol. This unintended release can lead to elevated drug levels, increasing risks of toxicity, side effects, or overdose. Mechanisms of Alcohol Dose Dumping Drugs at Risk Clinical Implications Preventive Measures Patient Strategies Regulatory ... Read More
CAS (Chemical Abstracts Service)
What is the CAS chemical number? A CAS Registry Number is a unique and unambiguous identifier for a specific substance that allows clear communication and, with the help of CAS scientists, links together all available data and research about that substance. Purpose of CAS Number 01) Uniqueness CAS numbers are ... Read More