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QbD enabled Process Variable Study to Develop Sustained Release Chitosan-Alginate Embedded Delivery System for Improved Patient Compliance
Sharma, Vijay; Singh, Lalit; Verma, Navneet.
  • Sharma, Vijay; IFTM University. Pharmacy Academy. Moradabad. IN
  • Singh, Lalit; Future Group of Institutions. Bareilly. IN
  • Verma, Navneet; IFTM University. Pharmacy Academy. Moradabad. IN
Braz. J. Pharm. Sci. (Online) ; 58: e19803, 2022. tab, graf
Article in English | LILACS | ID: biblio-1394043
ABSTRACT
Abstract The current investigation entail systematic Quality by Design (QbD)-enabled approach for the development of Sustained released embedded drug delivery systems of L-Arginine employing ionic gelation technique to attain improved patient compliance. Hence, in this QbD enabled systematic approach; quality target product profile (QTTP) was defined and critical quality attributes (CQAs) were identified. Further the risk assessment studies were undertaken through Ishikawa fish bone diagram to locate the critical material attributes (CMAs) and/or critical process parameters (CPPs) for the formulation of beads that may affect CQAs of drug product. A face centered central composite design (CCD) for two factors at three levels each with α =1 was employed for the optimization process to checkout the impact of concentration of sodium alginate and concentration of chitosan as CMAs which wereprior identified from risk assessment study and further evaluated for CQAs viz. bead size, swelling index and percent drug entrapment. The optimum formulation was embarked upon by using mathematical model being developed yielding desired CQAs. Thereby chitosan coated calcium-alginate delivery system was successfully developed by strategically employing QbD approach.In a nutshell, the presentinvestigation reports the successful development of optimized chitosan coated alginate beads employing QbD approach which can serve as a platform for other drugs too.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Patient Compliance / Drug Delivery Systems / Risk Assessment / Chitosan / Methods Type of study: Etiology study / Prognostic study / Risk factors Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2022 Type: Article Affiliation country: India Institution/Affiliation country: Future Group of Institutions/IN / IFTM University/IN

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Full text: Available Index: LILACS (Americas) Main subject: Patient Compliance / Drug Delivery Systems / Risk Assessment / Chitosan / Methods Type of study: Etiology study / Prognostic study / Risk factors Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2022 Type: Article Affiliation country: India Institution/Affiliation country: Future Group of Institutions/IN / IFTM University/IN