FUNCTIONALITY EVALUATION OF EXCIPIENTS MANUFACTURED BY DIFFERENT MANUFACTURERS

BS Muddukrishna

Abstract

Purpose: The main aim of this article is to develop an alternate source for excipients manufactured by
different manufacturers. Methods: Four different excipients were selected for this study and evaluated based on their
functional characteristics. Results: From the results obtained, the both vendors of the materials were showing
equivalent each other when we compared with the monograph specifications, analytical results and functionality
characteristics. Conclusion: Functionality evaluation of excipients were determined based on the specification
comparison, analytical results comparison and finally with functionality characteristics of excipients and their impact
on formulation.

Full Text:

PDF

References

George Collins, David Fillar, David Klug

(2014) The International Pharmaceutical Excipients

Council Significant Change Guide for

Pharmaceutical Excipients. 3rd ed. Europe: Katrin

Baldrich, F. Hoffmann, 1-27.

Mohan Ranga Reddy G, Aruna R, Sudhakar babu

AMS, Venkateswararao P (2013) A review on

alternate vendor development. International Journal

of Research in Pharmaceutical and Nano Sciences,

(5):536- 547.

United States Pharmacopoeia USPXXXIV,

NFXXIX. General Notices, 4.10 Monographs.

Rockville: The United States Pharmacopeial

Convention, I.

George E Reier (1960) FMC Bio Polymer. America:

Thomas A. Wheatley, 1-27.

Gregory E Amidon (2007) Proposed New USP

General Information Chapter, Excipient

Performance. Pharmacopeial Forum, 33(6):1311-

Patel Hardik, Shah Viral, Upadhyay Umesh (2011)

New pharmaceutical excipients in solid dosage

forms-A review. International journal of pharmacy

& life sciences, 2(8):1006-1019.

Lalduhsanga Pachuau C. Malsawmtluangi, Nath

NK, Ramdinsangi H, Vanlalfakawma David C,

Tripathi Shri Kant (2013) Physicochemical and

functional characterization of microcrystalline

cellulose from bamboo (Dendrocalamus

longispathus). International Journal of PharmTech

Research, 5(4):1561-1571.

Ohwoavworhua FO, Adelakun TA (2005) Some

Physical Characteristics of Microcrystalline

Cellulose Obtained from Raw Cotton of

Cochlospermum planchonii. Tropical Journal of

Pharmaceutical Research, 4(2):3-4.

PubChem (2005)

Aspartame.Available:http://pubchem.ncbi.nlm.nih.g

ov/compound/aspartame#section=InChI-Key. Last

accessed 24th sep 2015.

Ramesh T, Yasmeen S, Ramesh M, Vasanth PM

(2014) Comparative evaluation of excipientsfrom

different vemnders and their impact on identified

formulations. Journal of pharmaceutical science and

innovation. 3 (1):62-69.

Raymond C Rowe, Paul J Sheskey and Marian E

Quinn (1986) Handbook of pharmaceutical

excipients. 6th ed. London: Pharmaceutical press

and the American Pharmacist Association. P48-

,129-131.

Chaudhari SP, Patil PS (2012) Pharmaceutical

Excipients: A review. International journal of

advances in pharmacy, biology and chemistry,

(1):21-34.

Umeh Ogochukwu Ngozi C, Nworah Augustine

Chizoba, Ofoefule Sabinus Ifeanyichukwu (2014)

Physico-chemical properties of microcrystalline

cellulose derived from indian bamboo (Bambusa

Vulgaris). International Journal of Pharmaceutical

Sciences Review and Research, 29(2):5-9..

Freny Hirpara, Debnath SK, Saisivam S (2014)

Optimization & screening of different film forming

polymers and plasticizers in fast dissolvingsublingual film. International Journal of Pharmacy

and Pharmaceutical Sciences, 6(1):41-42.

Bang F, Broicher C (2010) Evaluating the different

characteristics of plasticizers used in cationic

polymer based film-coating applications. Available:

http://www.pharmaingredients.basf.com/Documents

/ENP/Poster/EN/GENPET401.pdf. Last accessed

nd Jan 2016.

Anthony Grilli, general manager, sgs life science

services, fairfield, nj, usa. (2010). Managing

excipient testing: functional and safety testing in a

globalmarketplace. Available:http://www.sgs.com/~

/media/Global/Documents/Technical%20Document

s/SGS-QC-RD-Excipient-Testing-TB26-EN-10.pdf.

Last accessed 3rd Jan 2016.

Refbacks

  • There are currently no refbacks.