Carobomer Based Controlled Release Designs of Atorvastatin Calcium Tablets Evaluated Using Quality by Design (QbD) Approach

Nair, Arunkanth Krishnakumar; Ramana, P. Venkata; Rao, Prasada; Bapatu, Hanimi Reddy; Ganthi, Hari Kishan Reddy; Mallu, Useni Reddy

doi:10.4236/ajac.2017.83016

Cited by 4 publications

(3 citation statements)

References 16 publications

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“…Our research during the pharmaceutical development process concentrated on the CQAs that might be impacted by a practical modification to the manufacture or formulation of the drug product. Assay, homogeneity of dosage units (CU), dissolution, and related substances (organic impurities) were all considered CQAs [13,14].…”

Section: Compatibility Studiesmentioning

confidence: 99%

“…Studies on solubility and physical-chemical characteristics were carried out to help choose the API. The wet granulation procedure was suggested to enhance the final blend's flow characteristics and maintain uniform weight during compression [10][11][12][13][14][15]. The quality of the drug product and consistency of the outcomes were produced using the QBD approach.…”

Section: In Vitro Dissolution Study For Formulation and Process Varia...mentioning

confidence: 99%

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A QBD With the Fractional Factorial Design Was Used to Match the Similarity Between Ranolazine Extended-Release Tablets 500 Mg and 1000 Mg

et al. 2023

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Objective: Formulation and development of Ranolazine extended-release Tablets 500 mg and 1000 mg by using QBD with Fractional factorial design to match the similarity with Branded formulation (RANEXA®). Methods: Ranolazine extended-release tablets were developed by using various polymers, Polyquid PA100 and ETHOCEL TMstandard 7 premium and Hypromellose with a wet granulation process. QBD (Quality by Design) approach was used to identify the formulation and process variables that may affect the CQAs (critical quality attributes). Excipient compatibility studies were conducted to identify the interaction between API (active pharmaceutical ingredient) and selected excipients. Additionally, using a two-level, fractional factorial (22+3) design, the DOE (design of experiments) was employed to confirm the impacts of key process factors (fluid uptake and kneading time) on the formulation's ability to match the dissolution (f2) compared to RLD (reference listed drug) and establish a stable formulation. Results: Initial risk assessment was carried out to identify the various attributes such as API flow properties, solubility, PSD, Hygroscopicity, formulation, and process variables to impact the quality of the drug product. Flow properties of API indicate poor flow. Drug and excipients compatible study results indicate that excipients used in the compatibility study are considered compatible with the active ingredient. As per the saturation solubility studies and sink conditions, dissolution media was selected. Significant differences were found among the drug release profile by examining the various levels of polymers and binders. Using a two-level, fractional factorial (22+3) design, optimum process parameters were identified with selected formulation to match the dissolution (f2) similarity with the reference listed drug (RLD); finally, XRD (X-ray diffraction) studies confirm that the crystalline polymorphic forms (Form 1) peaks in optimum formulation (F07) comparable to the reference listed drug. Conclusion: Optimized formulation and process were established with QbD (quality by design) that provides the consistent drug release to match the f2 similarities with the extended-release tablets of RANEXA®(Ranolazine) 500 mg and 1000 mg.

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Section: Compatibility Studiesmentioning

confidence: 99%

Section: In Vitro Dissolution Study For Formulation and Process Varia...mentioning

confidence: 99%

A QBD With the Fractional Factorial Design Was Used to Match the Similarity Between Ranolazine Extended-Release Tablets 500 Mg and 1000 Mg

et al. 2023

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“…The medicine is released at a steady pace in a controlled release dose form, allowing therapeutic plasma levels to be maintained. It lowers the frequency of dose and lessens the risk of side effects [1].…”

Section: Introductionmentioning

confidence: 99%

Controlled Release Formulation of Tofacitinib Citrate Tablets Evaluated Using Quality by Design (QBD) Approach

Barik¹,

Soni²,

Kharia

2021

JPRI

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The goal of the project is to use the quality-by-design (QbD) method to create and optimise Tofacitinib citrate matrix tablets with controlled release excipients. The drug's physicochemical parameters, reference product characterisation, QTPP (Quality Target Product Profile), and CQAs were used to start product development (Critical Quality Attributes). Hypromellose (Methocel K100 premium LV CR), Polyethylene Oxide (SentryPolyox WSR N80 LEO), and Magnesium Stearate were used as formulation variables and were optimised together. The complete factorial design of experiment (DOE) with three centre points was used to investigate traditional monolithic controlled release matrix tablets. Using Design-expert12 programme, dissolution was assessed as CQA. At acidic pH, hypromellose with a higher viscosity grade provides a regulated release pattern by retaining the integrity of the medication and preventing rapid drug release. Due to the nonionic nature of the polymer, drug release from the polymer matrices is pH independent. Present monolithic controlled release matrix system the extensive degradation of Tofacitinib Citrate in the acidic condition can be avoided with desired in-vitro drug release.

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Utilizing Quality by Design to Develop and Evaluate Extended-Release Upadacitinib Tablets Incorporating a Biosynthesized Polymer

Sunil Chowdary,

Napoleon

2023

J Pharm Innov

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Carobomer Based Controlled Release Designs of Atorvastatin Calcium Tablets Evaluated Using Quality by Design (QbD) Approach

Cited by 4 publications

References 16 publications

A QBD With the Fractional Factorial Design Was Used to Match the Similarity Between Ranolazine Extended-Release Tablets 500 Mg and 1000 Mg

A QBD With the Fractional Factorial Design Was Used to Match the Similarity Between Ranolazine Extended-Release Tablets 500 Mg and 1000 Mg

Controlled Release Formulation of Tofacitinib Citrate Tablets Evaluated Using Quality by Design (QBD) Approach

Utilizing Quality by Design to Develop and Evaluate Extended-Release Upadacitinib Tablets Incorporating a Biosynthesized Polymer

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