June 19, 2022
Standard Operating Procedure for Perforated Coating Pan System / Automatic Tablet Coater
Standard Operating Procedure for Perforated Coating Pan System / Automatic Tablet Coater The purpose of this SOP is to establish a standard procedure for operating the coating pan system. This will be applicable for the tablet coater in the coating area of the production section. A standard operating procedure (SOP) is a document that provides…
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June 19, 2022
Dosage Forms
Dosage Forms Unit doses, likewise called dosage forms, are pharmaceutical drug products in the form in which they are advertised for use. Dosage forms are composed of a specific mixture of both active and inactive excipients in a capsule shell (for example) and apportioned into a specific dose. For instance, two items may both be…
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June 19, 2022
Tablet Coating
Tablet Coating Tablet coating deformations or issues seen during tablet coating are a fundamental subject, and in this article, we will look at tablet remaining and picking, which are perhaps the most commonly perceived defects seen during tablet coating. Tablet sticking and picking are two looking like deformities during the tablet coating processes, in which…
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June 19, 2022
Enteric Coated Tablets
Add Your Heading Text Here Enteric coating is a process wherein a layer of polymer is applied to the oral solid dosage forms to safeguard the medication discharge in the acidic environment of the stomach and to deliver the medication at an alkaline pH in the small intestine. The word enteric is connected with the…
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June 19, 2022
Detailing of Tablet Coating
Detailing of Tablet Coating Detailing of Tablet Coating Tablet coating is a cycle where a thin layer of polymer is applied over a centre tablet, and the weight gain of the film might fluctuate from 1-5 % for film coating to 10-12% for enteric coating. Sugarcoating is likewise a kind of coating, yet in sugar…
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May 30, 2022
Active Pharmaceutical Ingredient
Active Pharmaceutical Ingredient The active pharmaceutical ingredient, also known as API, is the main element that is a biologically active part of medicines or pesticides, which plays a big role in providing a therapeutic effect. A dosage form is a finalised form of a finished product, which is composed mainly of two components, namely, the…
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May 26, 2022
Disintegration Test
Disintegration Test Disintegration is the separation of tablets or capsules into small parts. It is a cycle wherein tablets or capsules are changed over into little particles while coming into contact with liquid, which goes through sieve number 10 or a 2.0±0.2 mm sifter, leaving no hard mass. A disintegration test is performed to guarantee…
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March 24, 2022
The Mutual Recognition Procedure
The Mutual Recognition Procedure As the necessities for this methodology are nitty-gritty in mandates, as opposed to guidelines, every EU Member State has public regulation that gives effect to these requirements. The MRP permits the dynamic augmentation of MAs from one Member State to another. The technique depends on the standard of common acknowledgement of…
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March 10, 2022
The Centralised Procedure – Assessment Procedure
The Centralized Procedure – Assessment Procedure Accelerated Assessment If the product is considered to be of major public health interest and is innovative, the accelerated assessment may be requested under Article 14(9). A request for accelerated assessment should be submitted as early as possible, but this must be at least 10 days before the CHMP…
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March 9, 2022
Application Routes in the EU – The Centralized Procedure
Application Routes in the EU – The Centralized Procedure Legislation and Eligibility A current framework of legislation that details the centralised procedure is as follows: Regulation No 726/2004 Regulation No 726/2004 replaced Regulation No 2309/93 as of 20 April 200. However, only Title IV was implemented at this date. Other Titles were implemented on 20…
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