Novel omeprazole delayed release orally disintegrating tablets for enhanced patient compliance: a case of model informed formulation development-Reference-Cited by-同舟云学术

Novel omeprazole delayed release orally disintegrating tablets for enhanced patient compliance: a case of model informed formulation development

Published:2024-08-21 Issue: Volume: Page:1-13
ISSN:0049-8254
Container-title:Xenobiotica
language:en
Short-container-title:Xenobiotica

Author:

Boddu Rajkumar¹,Kollipara Sivacharan¹,Kambam Veena²,Khan Sohel Mohammed²,Behera Soumyajit³,Murty NNVVSS Narayana⁴,Baheti Nitin³,Choudhury Anup A.³,Ahmed Tausif¹²

Affiliation:

1. Biopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad, Telangana, India

2. Clinical Pharmacokinetics, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy’s Laboratories Ltd, Bachupally, Hyderabad, Telangana, India

3. Formulation Research & Development, Integrated Product Development Organization (IPDO), Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad, Telangana, India

4. Analytical Research & Development, Integrated Product Development Organization (IPDO), Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad, Telangana, India

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/00498254.2024.2391519

Reference35 articles.

1. Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions

2. Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

3. Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics – a case study and utility in regulatory justifications

4. Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions

5. Experience on Utilization of Novel Modeling & Simulation Approaches in Generic Product Development