RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION

1.0

NAME OF CANDIDATE AND

ADDRESS

2.0

NAME OF THE INSTITUTION

LATHA Y.R
D/O RAMAIAH H P
84, IV CROSS
VIDYARANYA NAGAR,
MAGADI ROAD, TOLGATE
BANGALORE- 560023
AL-AMEEN COLLEGE OF
PHARMACY,
HOSUR ROAD
BANGALORE-560027

3.0

COURSE OF STUDY SUBJECT

M.PHARM
PHARMACEUTICAL CHEMISTRY

4.0

DATE OF ADMISSION

01/06/2007

5.0

TITLE OF TOPIC

SYNTHESIS AND IDENTIFICATION

OF DIFFERENT POLYMORPHS OF
PITOFENONE HYDROCHLORIDE
BY FTIR AND X-RAY DIFFRACTION
SPECTROMETRY

5.1

System of study

CO2CH3
O

.HCl
N

Pitofenone Hydrochloride

6.0

BRIEF RESUME OF THE INTENDED WORK

6.1

NEED FOR THE STUDY

Pitofenone Hydrochloride, a potent and long acting anti-spasmodic agent is
widely used for its useful effects. Though lot of research has been done with regard
to its SAR studies, not much work has been done on its different polymorphs .Since,
Pitofenone Hydrochloride is known to exhibit polymorphism, a detailed study of
polymorphs of Pitofenone Hydrochloride and characterization of different
polymorphs of this drug by FTIR and X-ray diffraction spectrometry is essential.

6.2

REVIEW OF LITERATURE

Study was reported on polymorphism of drugs and their related biological activity1 .

Study was reported on polymorphism of drugs and their related biological activity2 .

Study was reported on polymorphism of drugs and their related biological activity3 .

A potent and long acting antispasmodic agent was reported4.

Method of blocking nerve conduction by treatment with branched chain esters of 2-4(2-piperidine-ethoxy)-benzoyl-benzoic acid and pharmaceutically acceptant salts was
reported5.

Acetylcholinesterase inhibition by pitofenone: a spasmolytic compound was

reported6.

Antispasmodics-A new perspective was reported7.

Open Labelled Evaluation of Injection Manyana (A Combination of Diclofenac +

Pitofenone + Fenpiverinium) in Ureteric , Biliary and Intestinal spasm-A Preliminay
Report8.

A method for the esterification of hindered acids9.

A simple quantitative method for the esterification of carboxylic acids10.

6.3:- OBJECTIVE OF STUDY

As polymorphism exhibited by drugs has a definitive relation to the biological
activity, this project aims at studying the polymorphism exhibited by Pitofenone
Hydrochloride and characterize the different polymorphs. Also the synthesis of
Pitofenone Hydrochloride shall be modified to suit the industrial requirements.

7.0:- Materials And Methods

7.1:- SOURCE OF DATA
Chemical abstract and other journals like European journals of medicinal
chemistry, Indian journal of chemistry, Japanese journal of pharmacology, Asian journal
of chemistry, Indian Institute of Science. www.pubmed.com, www.sciencedirect.com.
7.2:- METHODS OF DATA COLLECTION
Chemicals and other reagents will be collected from standard companies. The
reaction will be monitored by thin layer chromatography. The product will purified by
standard protocols. Structure of the synthesized compounds will be confirmed by spectral
studies. X-ray diffraction studies shall be conducted in the Indian Institute of Science.

7.3:-DOES THE STUDIES REQUIRE ANY INVESTIGATION TO BE

CONDUCTED ON PATIENTS OR ANIMAL
-Not Applicable-

7.4:-HAS ETHICAL CLEARENCE BEEN OPTAINED FROM YOUR

INSTITUTION IN CASE OF 7.3?
-Not Applicable-

8.0:- REFERENCES

1. Hansch C, Sammes PG, Taylor JB. Comprehensive Medicinal Chemistry. 1990; 1(I):
356-8.
2. Abraham DJ. Burgers Medicinal Chemistry and Drug Discovery.2007; 2(VI):652-4.
3. Brahmankar DM, Jaiswal SB. BioPharmaceutics and Pharmacokinetics.1995;27-30.
4. Bal-Tembe S, Bhedi DN, Mishra AK, Rajagopalan R, Ghate AV, Subbarayan P, Punekar
NS, Kulkarni AV. A potent and long-acting antispasmodic agent. Bioorg Med
Chem.1997; 5(7):1381-7.
5. Method of blocking nerve conduction by treatment with branched chain esters of 2-4-(2piperidine-ethoxy)-benzoyl-benzoic acid and pharmaceutically acceptant salts was
reported. US Patent issued on October 13, 1998.
6. Punekar NS, Kulkarni AV. Acetylcholinesterase inhibition by Pitofenone: a spasmolytic
compound. Biotechnol. Appl. Biochem. 1991.
7. Kulkarni KS. Antispasmodics-a new perspective. Jama India. 2001; 4(8):119-21.
8. Golhar KB, Gupta RL. Open Labeled Evaluation of Injection Manyana (A Combination
of Diclofenac + Fenpiverinium) in Uretic, Biliary and Intestinal Spasm-A Preliminary.

Report Indian Med Assoc. 1999 Sep; 97(9):398-400.

9. Parish RC, Stock LM.A method for esterification of hindered acids.J. Org.
Chem.1965;30:927-29.
10. Shaw JE, Kunerth DC, Sherry JJ. A simple quantitative method for the esterification of
carboxylic acids. Tetrahedron letters.1973;(9):689-92.

9.0

SIGNATURE OF THE CANDIDATE

10.0

REMARKS OF THE GUIDE

11.0

NAME AND DESIGNATION OF

Recommended for Research.

Dr. GOPAL KRISHNA RAO

Professor and Head
Dept. of Pharmaceutical Chemistry
Al-Ameen College of Pharmacy,
Bangalore-560027.

11.1:- GUIDE

11.2:- SIGNATURE
11.3:- CO-GUIDE

Dr. RAMESHA A.R.

Vice President- Technical,
R.L. Fine Chem. II,
C-15, KHD Industrial area, Yalahanka,
Bangalore-560064.

11.4:- SIGNATURE

11.5:- HEAD

11.6:-

12.0

12.1

OF THE DEPT

Dr. GOPAL KRISHNA RAO

Professor and Head
Dept. of Pharmaceutical Chemistry
Al-Ameen College of Pharmacy,
Bangalore-560027.

SIGNATURE

REMARKS OF THE PRINCIPAL

:- SIGNATURE

Recommended for Research

And Submission of
Dissertation.

Prof B.G.Shivananda.
PRINCIPAL
Al-Ameen College Of Pharmacy,
Bangalore 560027