ABSTRACT

The quality of any pharmaceutical product is always considered to be an important concern from the time when the pharmaceutical field came into existence. When a product is being developed by a pharmaceutical manufacturer, the testing and evaluation process of that product turns out to be very expensive as well as it is quite a time taking process also. The assurance and belief that the pharmaceutical product manufactured is of the requisite quality and efficacy in terms of its final output can be brought up with the implementation of Quality by Design (QbD) methodology. The topical formulations have been used from many decades which possess a semisolid character and comprises of gel, ointments, creams etc. The topical drug delivery in an optimum manner requires an important prerequisite of maintaining the therapeutic level of the drug throughout the time period of treatment. The requirement of QbD technique in a process development is encouraged by many pharmaceutical manufacturers in the present time as this could be used efficiently in identifying the parameters which generally affect the quality as well as efficacy of a pharmaceutical product. The primary QbD elements such as quality target product profile, critical quality attributes, critical material attributes, critical process parameters have been used during the manufacturing of the product so that the required profile of the product could be achieved. Keywords: Quality by Design (QbD), Topical drug delivery, Semisolid dosage form, QbD tools, Advantages, Quality target product profile, Critical quality attributes, Critical material attributes, Critical process parameter
Publication date: 01/03/2024

https://ijbpas.com/pdf/2024/March/MS_IJBPAS_2024_7623.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.3.7623