Regulatory Perspective Reverse Engineering Analysis of the Mast Cell Stabilizer and the Histamine Receptor Antagonist (Olopatadine HCl): Instrumental and Classical Methods for Multiple Formulations-Reference-Cited by-同舟云学术

Regulatory Perspective Reverse Engineering Analysis of the Mast Cell Stabilizer and the Histamine Receptor Antagonist (Olopatadine HCl): Instrumental and Classical Methods for Multiple Formulations

Published:2023-06-08 Issue:24 Volume:8 Page:21485-21492
ISSN:2470-1343
Container-title:ACS Omega
language:en
Short-container-title:ACS Omega

Author:

Kowtharapu Leela Prasad¹²,Katari Naresh Kumar²³^ORCID,Sandoval Christian A.¹,Konduru Naresh⁴^ORCID,Muchakayala Siva Krishna⁵,Pydimarry Surya Prakash Rao⁶,Jonnalagadda Sreekantha Babu³^ORCID

Affiliation:

1. Analytical Development Department, Shenzhen DEC Pharmaceutical Co., Ltd., Shenzhen 518000, China

2. Department of Chemistry, School of Science, GITAM Deemed to be University, Hyderabad, Telangana 502329, India

3. School of Chemistry & Physics, College of Agriculture, Engineering & Science, Westville Campus, University of KwaZulu-Natal, P Bag X 54001, Durban 4000, South Africa

4. Analytical Research and Development, Zhuhai Resproly Pharmaceutical Technology Co., Ltd., Zhuhai City, Guangdong Province 519040, China

5. Analytical Research and Development, Catalent Pharma Solutions, 1100 Enterprise Drive, Winchester, Kentucky 40391, United States

6. Analytical Research & Development, Hikma Pharmaceuticals USA Inc., Columbus, Ohio 43064, United States

Funder

Gandhi Institute of Technology and Management

DEC Pharmaceutical Co. Ltd

Publisher

American Chemical Society (ACS)

Subject

General Chemical Engineering,General Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acsomega.3c00311

Reference24 articles.

1. Reverse engineering and formulation by QBD of olopatadine hydrochloride ophthalmic solution

2. Gamache, D. A.; Alani, L.; High concentration olopatadine ophthalmic composition. U.S. Patent 8,791,154 B2, 2014 (accessed Dec 21, 2022).

3. Singh, O. N.; Wall, G. M.; Olopatadine formulations for topical nasal administration. U.S. Patent 7,977,376 B2, 2011 (accessed Dec 21, 2022).

4. Singh, O. N.; Wall, G. M.; Olopatadine formulations for topical nasal administration. U.S. Patent 8,399,508 B2, 2013 (accessed Dec 21, 2022).

5. www.fda.gov (accessed: 21 December, 2022).

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