Dealing With the Challenges during Large Scale Manufacturing of Polymorphic Drug Substances

Sudhir Sawant; Ramesh Yamgar

Asian Journal of Research in Pharmaceutical Sciences

ISSN

2231-5659 (Online)
2231-5640 (Print)

Submit Article

Dealing With the Challenges during Large Scale Manufacturing of Polymorphic Drug Substances

Author(s): Sudhir Sawant, Ramesh Yamgar

Email(s): sawantsudhir@hotmail.com

DOI: Not Available

Address: Sudhir Sawant* and Ramesh Yamgar
P. G. Dept of Chemistry, Govt. of Maharashtra’s Ismail Yusuf College of Arts, Science and Commerce, Jogeshwari (East), Mumbai 400 060 INDIA
*Corresponding Author

Published In: Volume - 1, Issue - 3, Year - 2011

View HTML

View PDF

ABSTRACT:
This paper will discuss the various risks and challenges that manufacturers face regarding the manufacturing of polymorphically pure products especially APIs and detailed specific risks during manufacturing in commercial plants and precautions to be taken during manufacturing, quality inspections and also during their product development efforts in R and D. A conscious approach of all personnel involved in manufacturing teams towards ensuring the polymorphic purity of the drug substance is very much essential element for regulated markets and for business continuity of a generic firm.

Keywords:

Cite this article:
Sudhir Sawant, Ramesh Yamgar. Dealing With the Challenges during Large Scale Manufacturing of Polymorphic Drug Substances. Asian J. Res. Pharm. Sci. 1(3): July-Sept. 2011; Page 63-68.

Cite(Electronic):
Sudhir Sawant, Ramesh Yamgar. Dealing With the Challenges during Large Scale Manufacturing of Polymorphic Drug Substances. Asian J. Res. Pharm. Sci. 1(3): July-Sept. 2011; Page 63-68. Available on: https://ajpsonline.com/AbstractView.aspx?PID=2011-1-3-3

Influence of Newly Synthesized Superdisintegrant on Dissolution Rate Enhancement of Carbamazepine using Liquisolid Compact Technique

Author(s): Vrushali G. Raut, Bharatee P. Chaudhari, Vivekkumar K. Redasani

DOI: 10.52711/2231-5659.2022.00018 Access: Open Access Read More

Formulation and evaluation of delayed release pantoprazole Tablets

Author(s): Viral Patel

DOI: Access: Open Access Read More

Novel Drug Delivery Systems of Herbal Constituents Used in Acne

Author(s): Surekha Baghel, Bina Gidwani, Chanchal Deep Kaur

DOI: 10.5958/2231-5659.2017.00009.1 Access: Open Access Read More

Development and Validation of Analytical Method for Bromhexine Hydrochloride, Chlorpheniramine Maleate and Guaifenesin by Simultaneous Equation Spectroscopic Method

Author(s): Ladmeera, Hasumati Raj, Vineet Jain

DOI: 10.5958/2231-5659.2015.00013.2 Access: Open Access Read More

Asian Journal of Research in Pharmaceutical Sciences (AJPSci) is an international, peer-reviewed journal, devoted to pharmaceutical sciences....... Read more >>>

RNI: Not Available
DOI: 10.52711/2231-5659