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Redasani, Vivekkumar
- A Compendious Review on Biodegradable Polymeric Nanoparticles
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1 Yashoda Shikshan Prasarak Mandal, Yashoda Technical Campus, Faculty of Pharmacy, Wadhe NH4, Satara. 415011, Maharashtra, IN
1 Yashoda Shikshan Prasarak Mandal, Yashoda Technical Campus, Faculty of Pharmacy, Wadhe NH4, Satara. 415011, Maharashtra, IN
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Asian Journal of Pharmacy and Technology, Vol 12, No 4 (2022), Pagination: 371-381Abstract
Polymeric nanoparticles (NPs) are among the eminently designed organic nanomedicine. There is a lot of elation about polymeric NPs' potential to revolutionize modern medicine. Particle size, morphology, material selection, and processing methods are all being studied to synthesize the perfect nanosystem for effectual and precisely target bioactive. PNPs have the ability to significantly elevate the potency of therapeutic medication by allowing for targeted distribution to a specific location. Drug delivery techniques such as conjugation and trapping of medicines, prodrugs, stimuli-responsive systems, imaging modalities, and theranostics all use polymeric NPs. The review focuses on the array of existing approaches for the producing of polymeric nanoparticles. We want to draw attention to several natural and synthetic biodegradable polymers. Polymers' physiochemical properties can be tweaked to provide distribution through several biological barriers in order to reach distinct organs or cells. The use of biodegradable polymers as nanocarriers is particularly appealing since these materials can be tailored to degrade in physiological system. Additionally, in the next part, the characterization methods for this type of nanoparticles are discussed.Keywords
Targeted Delivery, Controlled Manner, Biodegradable Polymer, Nanocarrier, Polymeric Nanoparticles
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- Quality by Design (QbD) concept Review in Pharmaceuticals
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1 YSPM'S, Yashoda Technical Campus, Faculty Of Pharmacy, Wadhe, Satara., IN
1 YSPM'S, Yashoda Technical Campus, Faculty Of Pharmacy, Wadhe, Satara., IN
Source
Asian Journal of Research in Chemistry, Vol 15, No 4 (2022), Pagination: 303 - 307Abstract
Quality by Design (QbD) refers to a holistic approach towards drug development. Quality by design is a vital part of the modern approach to pharmaceutical quality. The purpose of this practice school topic is to discuss the pharmaceutical Quality by Design (QbD) and illustrate how it can be used to ensure pharmaceutical quality. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining Quality target product profile, identifying critical quality attributes, link the drug excipients attributes, establishing design space, control strategy, critical process parameters and product life cycle management. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. A new approach to drug development could increase efficiencies, provide regulatory support and flexibility, and offer important business benefits throughout the product’s life cycle. This PS topic explores the processes used in developing a market formulation and required supportive data, particularly in light of the industry’s current movement toward submissions based on QbD. The work also facilitates the adoption and implementation of QbD. Principles in the development of pharmaceutical industries. Successful implementation of QbD concepts requires cooperation across a multitude of company teams, from R&D to manufacturing to quality control and regulatory affairs. This is necessary to ensure that QbD concepts are incorporated not only when the first activities are initiated around a product’s design but also during the design of the process used to make the product and other activities associated with a product’s life cycle. The application of the concept of quality by design (QbD) presented in this paper aligns with the principles of ICH Q8, Q9 and Q10 guidelines.Keywords
Control strategy, Critical material attributes, Critical process parameters, Design space, Quality by design.References
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- Cleaning Validation in Pharmaceutical Industry
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1 YSPM’s Yashoda Technical Campus, Faculty of Pharmacy, Satara, 415003., IN
1 YSPM’s Yashoda Technical Campus, Faculty of Pharmacy, Satara, 415003., IN
Source
Asian Journal of Research in Chemistry, Vol 15, No 5 (2022), Pagination: 386 - 390Abstract
In pharmaceutical industries there is possibilities of contamination, cross contamination, microbial contamination, adulteration of drug with other active ingredient or contamination with other material like raw material, dust, lubricant, intermediates and air born particle.1 Cleaning validation validate the effectiveness of cleaning procedure for removal of excipient, product residue, degradation product and cleaning agent. Cleaning validation improves the potency and reliability of cleaning in given pharmaceutical production and equipment. The cleaning validation is essential part of the quality assurance. As a result, validating cleaning procedures is critical in the pharmaceutical sector to ensure the safety, efficacy, and quality of drug batches. The purpose of this review is to provide information about cleaning validation in pharmaceutical industry to provide better customer care and quality of product. This article will discuss the relevance of cleaning validation in the pharmaceutical sector, and it will do so in accordance with regulatory guidelines.2,3Keywords
Cleaning validation, Cleaning method, contamination, Sampling techniques, levels of cleaningReferences
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