In pharmaceutical tablet manufacturing granule size plays a critical role in ensuring smooth processing, uniformity, flowability, and compressibility. The optimal granule size depends on multiple factors, including the tablet weight, dosage form type, API properties, and manufacturing method. While there is no strict one-size-fits-all rule, certain guidelines are generally followed based on tablet weight ranges….
When we think of blending APIs and excipients, we think of uniformity, efficiency, and harmony. But what if I told you there’s an invisible force that can ruin your blend even before compression? Yes — Static Electricity. And it’s not just a physics problem. It’s a formulation nightmare. Let’s go deeper Why static charge forms…
At first glance, most people assume capsules always contain powder — but have you ever wondered why some are filled with liquid? Let’s break it down! Capsules generally come in two types: But why use liquid at all? Enhanced Absorption: Some drugs dissolve better in oil or other liquids, making them more bioavailable (faster and…
For a direct compression (DC)-based formulation to succeed, it demands strategic selection of excipients, API characterization, and continuous optimization based on product performance data. Below is a stepwise, flowchart-based approach to Direct Compression development 1. Evaluate the API These properties directly affect blend selection and performance. Example: If the API constitutes 30% w/w of the…
A Dirty Hold Time Study is conducted to determine the maximum allowable time that equipment can remain uncleaned after use without exceeding acceptable microbial contamination limits. This study ensures compliance with Good Manufacturing Practices (GMP) and helps establish cleaning validation parameters. Objective Equipment Selection Includes process equipment like: Focus on surfaces and areas prone to…
CIP is the process of cleaning equipment, tanks and production lines without dismantling them, by pumping detergents and water while they are in place, to save time and ensure the stability of cleanliness. Basic steps of CIP Common challenges in CIP Monitor performance and ensure efficiency Periodic maintenance and best practices Guidelines In order to…
Is there a requirement to run a leak test of lyophilizer after every cycle in GMP pharmaceutical production? GMP regulations do not mandate leak testing after every lyophilization cycle, but periodic testing is required to ensure equipment integrity and product quality. The frequency is determined by risk assessment, internal procedures, and process criticality. 1.1 European…
Persistent Challenges in Tablet Production If sticking or overlubrication is a permanent problem during tablet production, a useful alternative can be the external lubrication of the punches and dies. It is a standard add-on for modern rotary tablet presses. How Does External Lubrication Work? A nozzle sprays dry lubricant just before the feeder onto punches…
