Product Development, Manufacturing, and Packaging of Solid Dosage Forms Under QbD and PAT Paradigm: DOE Case Studies for Industrial Applications

Singh, Brahma N

doi:10.1208/s12249-019-1515-8

Cited by 10 publications

(3 citation statements)

References 61 publications

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“…Although the model is created for the process, the QbD control strategy as a whole is supported by the effectiveness of the analytical techniques and their findings. 23…”

Section: Applications Of Traditional Analytical Methods In Qbd Proces...mentioning

confidence: 99%

Overview: flexible and versatile approach of quality by design & process analytical technology in industries

Kutty,

Nikam,

Chaudhari

et al. 2024

JPBS

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Quality by Design (QbD) is crucial to the creation of contemporary in pharmaceuticals, microbiology, biotechnology, product management etc. In order to build proactive, scientific, and risk-based processes and products, QbD helps and supports both the industry and the FDA. Instead of waiting until the final quality check of the finished product, it is founded on the idea of establishing quality from the very beginning of the process. A successful plan that lowers batch failures and recalls is finally provided by an efficient QbD approach, which offers insights and crucial upstream information throughout the development process. The purpose of this review is to provide an overview of the implementation of Quality by Design (QbD), its tools, elements, and techniques, the relevancy with various guidelines, and the use in present-day pharmaceutical. The IQ Consortium provides information on the current situation of process analytical technology (PAT) as it relates to the creation of active pharmaceutical ingredients (API) in branded pharmaceutical firms. The article gives concrete examples of why and how the pharmaceutical industry uses PAT tools in API development by using an API process pipeline. PAT can reduce personnel risks involved with sampling dangerous compounds for in-process testing and increase R&D efficiency. Although not all chemical processes or stages are easily suited to applying the features of the PAT toolbox, PAT permits accurate and speedy (real or near time) evaluations of processes that might involve compounds that are highly dangerous, transitory, or heterogeneous when necessary. The major regulatory agencies and the biotech sector have worked hard to assist the application of the ideas of Quality by Design (QbD) and Process Analytical Technology (PAT) over the past ten years, with varying degrees of success. Despite the fact that just one biotech therapy has received approval under the QbD paradigm thus far, the tools and methods associated with these two ideas are deeply ingrained in the work procedures of the majority of international pharmaceutical firms. This overview is mainly focused on the QbD and PAT's development in the first place. Second, give an overview of QbD and PAT implementation and point out any places where more contributions are possible.

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“…Although the model is created for the process, the QbD control strategy as a whole is supported by the effectiveness of the analytical techniques and their findings. 23…”

Section: Applications Of Traditional Analytical Methods In Qbd Proces...mentioning

confidence: 99%

Overview: flexible and versatile approach of quality by design & process analytical technology in industries

Kutty,

Nikam,

Chaudhari

et al. 2024

JPBS

View full text Add to dashboard Cite

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“…For a disintegration profile to be thought of as comparative, the value of f2 ought to be somewhere in the range of 50 and 100. [9,18,19]…”

Section: Similarity Factormentioning

confidence: 99%

Quality by design approach for anti-hyperthyroid immediate release tablet of carbimazole

Ratnaparkhi¹,

Shinde²,

Ahire³

et al. 2022

ijhs

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The current study to formulate, evaluate and optimize carbimazole immediate release tablet by using quality by design approach. The look at of optimization formula and experimental design had been done with the aid of using design parameter primarily based totally on Box-Behnken design. Immediate release dosage form for rapid efficacy and inhibit the peroxidase enzymes and act as thyroid inhibitor. Method: Immediate release carbimazole tablets were manufactured by dry granulation using Quality by Design. The optimization of the formulation of tablets is done by examining the profile of the objective quality product. Microcrystalline cellulose, anhydrous lactose and magnesium stearate were all included in experiments designed using the Box-Behnken design. Their concentrations are influenced by the drug disintegration and release factor f2. Result: Optimized batch formulation shows immediate drug release with short disintegration time. In anova models are significant. Conclusion: The utilization of bound together quality by design approach for successful advancement of an IR carbimazole tablet. The effective tablet created with Box-Behnken designs.

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“…There are a large number of companies involved in the development and implementation of new technologies for packaging medicines on the market. Manufacturers are striving for the rational use of packaging materials to reduce production costs and improve product quality [48]. One of the most important requirements for packaging materials is the protection of the drug from exposure to light, atmospheric moisture, oxidation, microbial contamination [49,50] and what is also important the formation of drug compliance [51][52][53].…”

Section: Packaging Materialsmentioning

confidence: 99%

Approaches to the Search of the Optimum Packaging of Eye Drops

et al. 2022

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The purpose of this study is to find a unique ophthalmic packaging that takes into account modern requirements for both maintaining the quality and safety of the drug, compliance with therapy, and increasing the profitability and environmental friendliness of its production. Statistics from open international databases on drugs approved for ophthalmic therapy in 2022 are provided. The research criteria were a valid registration status, the type of packaging and the presence of a preservative in the composition of the eye drops. The results of statistical processing of databases of ministries of health of different countries have shown the relevance of monodose ophthalmic packaging, capable of long-term storage of the drug without preservatives. In many countries, particularly in Europe, many drugs in the form of a monodose containers are registered. On this basis, a unique aluminum-based monodose container design is proposed, eliminating the use of large quantities of plastic.

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Product Development, Manufacturing, and Packaging of Solid Dosage Forms Under QbD and PAT Paradigm: DOE Case Studies for Industrial Applications

Cited by 10 publications

References 61 publications

Overview: flexible and versatile approach of quality by design & process analytical technology in industries

Overview: flexible and versatile approach of quality by design & process analytical technology in industries

Quality by design approach for anti-hyperthyroid immediate release tablet of carbimazole

Approaches to the Search of the Optimum Packaging of Eye Drops

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