Pharma Digests
Why Vape Laced with Etomidate is Dangerous?
In brain, etomidate binds to and activate gamma-alpha butyric acid (GABA) receptor. This causes amnesia (forgetfulness), ataxia (unstable movement) and confusion. It further affects ‘wiring’ of a small part of the brain (hippocampus) and may retard brain development of young vapers. It also suppresses hormone and affects kidney and lung ... Read More
Alfentanil Interaction with Rifampin
Alfentanil is a potent, short-acting analgesic drug used for anesthesia in surgery. When alfentanil is administered to patients who were pre-treated with rifampin, an anti-tuberculosis drug, its level in our body (i.e. systemic exposure), was reduced 2- to 3-fold! A question arises: What are the rationales behind this interaction? Another ... Read More
Factors Affecting on Clearance of Apixaban
As we develop drugs to be more stable in our body (i.e. less prone to be broken down by liver), guess what is another route that the drugs are being eliminated from our body? It is intestinal excretion of drugs from the blood circulation to the intestinal lumen and out ... Read More
Removal of Drugs from Kidneys
There are three processes that contribute to the removal of drugs in our kidneys. A question arises: How can we easily predict the relative contributions of these 3 processes? Simple solution: Compare renal clearance (CLR) and filtration clearance (CLf)! We may further ask: how do we calculate CLR and CLf? ... Read More
Is f₂ in Multimedia a True Indicator of Bioequivalence?
The f₂ similarity factor is a commonly used mathematical tool in pharmaceutical development to compare the dissolution profiles of a test product and its reference listed drug (RLD). When the calculated f₂ value is ≥ 50, it indicates that the two profiles are similar under the tested conditions. Regulatory agencies ... Read More
Anatomy of an FDA Inspection | Part 2 of 2
Winning the Inspection Game – The Habits of Inspection-Ready Companies LIVE THE CULTURE: The entire organization, from top management to line operators, knows that quality isn’t a department—it’s a mindset. It’s part of the air you breathe, the decisions you make. Follow SOPs consistently, encourage employees to report and fix ... Read More
Anatomy of an FDA Inspection | Part 1 of 2
Inspections are how the FDA checks that what’s promised is real: FDA inspections can occur for various reasons – a routine schedule, a follow-up to a prior issue, a pre-approval for a new product, or “for-cause” in response to a specific problem. What Happens During an FDA Inspection? (And What ... Read More
How Are Nitrosamine Impurities Generated in Pharmaceuticals?
Nitrosamines are formed through specific chemical reactions during drug manufacturing or storage. These impurities have become a major focus for regulatory bodies due to their potential health risks. Here’s how they are generated: 1. Reaction Between Nitrites and Amines: 2. Use of Nitrosating Agents in Manufacturing: 3. API Degradation: 4. ... Read More
Can You Crush a Tablet Before Taking It?
Whether it’s for your grandma who can’t swallow, or your child who hates medicine… many of us have crushed tablets thinking it’s harmless. But did you know? Not every tablet is made for that. Let’s break it down simply: Tablets You Should NEVER Crush: 1. Enteric-Coated Tablets (EC) 2. Extended-Release ... Read More
Can You Store Tablets in the Fridge?
Short Answer: No, unless the label or pharmacist says so. Why You Shouldn’t Refrigerate Tablets? 1. Condensation = Killer 2. Not Designed for Cold 3. Packaging Breakdown When Fridge Is Okay for Medicines? Only store in the fridge if the label or pharmacist clearly says: “Store at 2–8°C” Examples: Insulin, ... Read More
Blister Pack vs. Bottle | The Real Reason Behind Packaging Choices
Ever wondered why some medicines come in blisters while others are in bottles? It’s not just about cost or convenience—there’s a lot more behind these decisions! 1. RLD (Reference Listed Drug) – The Hidden Decision Maker When a generic drug is developed, it must match the Reference Listed Drug (RLD), ... Read More