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 sticking 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 process, in which…
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June 19, 2022
Enteric Coated Tablets
Enteric Coated Tablets Enteric coating is a process wherein a layer of polymer is applied to 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 digestive tract, and…
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June 19, 2022
Detailing of Tablet Coating
Detailing of Tablet Coating 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 coating, rather…
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May 30, 2022
Active Pharmaceutical Ingredient
Active Pharmaceutical Ingredient 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,…
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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 Recognition Procedure As the requirements for this methodology are nitty-gritty 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…
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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 on this date. Other Titles were implemented on 20…
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February 28, 2022
Application Routes in the EU – National Procedures
Application Routes in the EU – National Procedures National Procedures In the European Union (EU), the application routes for obtaining marketing authorisation for medicinal products can be categorised into two main procedures: the centralised procedure and the national procedures. The centralised procedure is applicable for certain types of medicinal products, such as biotechnology-derived products, orphan…
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February 28, 2022
Application Routes in the EU
Application Routes in the EU Application Routes National systems are accessible only for items that are limited to the market of one Member State. To make a public application, the candidate presents the application for enlistment to the specialists of the Member State in which marketing is desired. Relevant prerequisites should be followed, e.g., installation…
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