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Topical Drug Manufacturing in Pharma - Short guide

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Mark William
Topical Drug Manufacturing in Pharma - Short guide

Most topical drug manufacturer produces a perfect formulation for the topical drugs implementing a flexible and easy process. Most of the topical formulations developed today are complicated and thus need tightly controlled parameters for processing. In this segment, we will have a close look at the additional strategies for optimizing the topical dosage drug manufacturing process. 

Implement the process controlling tools

Preserved topical drugs do not need the stringent processing controls that are associated with sterile manufacturing. Drug manufacturing organizations only have to control and understand that the procedure is crucial. Emulsions are a little difficult to process as they are thermodynamically and inherently unstable. The manufacturing vessel used with PLCs or Programming Logic Controllers is a tool that offers more precise and reliable control of the temperature or pressure and mixing time and speed. 

Protecting the API degradation

The manufacturing process of the leading topical drug manufacturer designs a system for protecting the API from physical degradation. Some API-like retinoic acid compounds are sensitive to both oxygen and UV light. The manufacturers protect the APIs by implementing amber and yellow light, free from the toxic lower wavelength UV rays by implementing argon, nitrogen, or other inert gas for purging the oxygen product. 

Constraints Identification related to the Equipment

The manufacturer should perform all the procedures implementing its recent equipment capacities. The scale path of the batch size of 1:10 from the clinical or pilot size to the commercial level must persist with exact equipment. 

Considering the regulatory necessities

The manufacturing organization faces satisfying regulatory necessities for the transfer, or the scale-up of the procedure is quite challenging. To enhance the method, the companies use the clinical bath or shift a commercial procedure to a new manufacturing site. The equipment needs to be of the same construction material and implement the same mixing type as mentioned in the guidance of SUPAC-SS. 

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