RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

Annexure-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE
AND ADDRESS (IN BLOCK LETTERS) / VIJAYANAND PUJARI
I M.PHARM (INDUSTRIAL PHARMACY),
J.S.S COLLEGE OF PHARMACY,
MYSORE-15
2. /

NAME OF THE INSTITUTION

/ JSS COLLEGE OF PHARMACY
3. /

COURSE OF STUDY AND SUBJECT

/ MASTER OF PHARMACY IN INDUSTRIAL PHARMACY
4. / DATE OF ADMISSION OF COURSE / 04-06-2007
5. /

TITLE OF TOPIC

/ A NEW ORAL DOSAGE FORM CONTAINING SILK FIBROIN GEL FOR ELDERLY PATIENTS
6. / BRIEF RESUME OF THE
INTENDED WORK
6.1 Need for the study
6.2 Review of the literature
6.3 Objectives of the study / ----- Enclosed-----
----- Enclosed-----
----- Enclosed-----
7 /

MATERIALS AND METHODS

7.1 Source of data
Laboratory based study
7.2 Method of collection of data
(Including sampling procedure,
if any)
Laboratory investigations
7.3 Does study require any
investigations or interventions
to conducted on patients or
other human or animal? If so,
please describe briefly
7.4 Has ethical clearance been
obtained from your institution
in case of 7.3? / ----- Enclosed-----
----- Enclosed-----
8 / LIST OF REFERENCES / ----- Enclosed-----
9 / Signature of candidate
10 / Remarks of guide
11
12 / Name and designation of
11.1 Guide
11.2 Signature
11.3 Head of department
11.4 Signature
12.1 Remarks of the
chairman and principal
12.2 Signature / Dr.P.K.KULKARNI
PROFFESOR,
DEPT OF PHARMACEUTICS
JSS COLLEGE OF PHARMACY,
MYSORE-15
Dr H.G. SHIVAKUMAR
PROF &HEAD
DEPT OF PHARMACEUTICS
JSS COLLEGE OF PHARMACY,
MYSORE-15

6.0  BRIEF RESUME OF THE NEEDED WORK

6.1 NEED FOR THE STUDY

Dysphagia(swallowing problem) can occur at any age but are most prevalent in elderly individuals and is a growing healthcare concern as geriatric population expands1. It causes significant morbidity and even mortality2. It is a common problem that lowers quality of life for the elderly patients2. Dysphagia causes potentially compromising nutritional status, complicating the administration of solid medications3. Its prevalence can be seen in several diseases like Advanced Alzheimer’s disease5, acute stroke4, head and neck cancer6, and in myasthenia gravis.

Dysphagia is common after acute stroke, occurring in 29%-64% of the patient4. The prevelance of dysphagia in patients with head and neck cancer was 50.6%8.

Dysphagia is among elderly people nevertheless swallowing problems always yet as an alarm symptom. Liquid formulations offer an alternative in whom dysphagia makes swallowing solid medicaments difficult7. There is clearly need for further studies into the prevalence, characteristics and management of dysphagia in elderly people in the community7.

Recently the silk fibroin gel is used in various research fields, formulating jelly like preparations for elderly patients9, in making hydrogels10, as a biomaterials11, in making osteoblast cultures and is used as novel material for controlled release of theophylline12.

Drotaverine HCl is an Antispasmodic drug, structurally related to papaverine. Drotaverine is a selective inhibitor of phosphodiesterase 4 enzyme, and has no anticholinergic effects. A study in 2003 found drotaverine to be nearly 80% effective in treating renal colic17.

Elderly patients with dysphagia face difficulty in administering solid medicaments7.A new oral dosage form containing silk fibroin gel would be an alternative dosage form for such patients. Silk fibroin may be used to formulate eatable gel.

6.2 REVIEW OF LITERATURE

Paterson WG. studied the problem of dysphagia in elderly and found that oropharyngeal dysphagia in the elderly is often due to irreversible neuromuscular disease and concluded that these patients benefit from swallowing therapy by speech pathologists2. Morris H . studied the incidence, causes, and management of dysphagia and nurse’s role in the management of this challenging disorder with particular emphasis on the care of the elderly patient3.

Takehisa Hanawa et al. studied the hydrolysis of trichlormethiazide (TCM) in silk fibroin gel (SFG) prepared in various sugar solutions such as ribose, fructose, mannose and glucose solutions9. M.fini et al. studied the invitro and invivo behavior of an injectable silk fibroin hydrogel through osteoblast cultures and concluded that silk fibroin is useful in orthopaedic surgery13. Xiaoquin wang et al. studied silk fibroin coating on PLGA (poly lactic co-glycolic acid) and alginate microspheres. Silk fibroin coating sustained protein drug release from the microspheres by providing an effective diffusion barrier14.Oguz Bayraktar et al. studied the potential use of the silk fibroin(SF) as an aqueous coating material for theophylline tablets. They have examined the film forming and coating properties of heat treated fibroin (SF). They concluded that silk fibroin can be considered as a potential aqueous film coating agent to be used for solid pharmaceuticals15.

Romics I et al. studied the spasolytic effect of drotaverine HCl in colicky pain and they found that drotaverine provides effective pain relief in more than two-thirds of patients with renal colic, with no serious side effects17.Bolaji OO et al. studied the pharmacokinetics and bioavailability of drotaverine was studied in 10 healthy volunteers after administration of single 80 mg oral and intravenous doses of the HCl salt of the drug, in crossover fashion. The drug was mainly eliminated by non-renal routes. The absolute bioavailability was variable and ranged from 24.5-91%18.

6.3 OBJECTIVES OF THE STUDY

1.  Extraction of silk fibroin from silk cocoons.

2.  To formulate eatable gel of silk fibroin containing drotaverine HCl.

3.  To perform invitro evaluation of the formulated gel, like gel strength, drug content uniformity, etc

4.  To carry out the stability of the gel preparation.

7.0  MATERIALS AND METHODS

7.1 SOURCE OF DATA

LABORATORY BASED STUDY

Silk Fibroin Eatable Gel will be prepared by suitable method. The prepared gel will be evaluated for various standards.

DRUG TO BE USED IN THE FORMULATIONS

Drotaverine HCl.

MATERIALS

·  Drug: - Drotaverine HCl.

·  Silk cocoon.

·  Silk Fibroin.

·  Sugars like: - Ribose, Fructose, Mannose, Glucose etc.

·  Glycerol etc

7.3  Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly

NO

7.4  Has ethical clearance been obtained from your institution in case of 7.3?

8.0  REFERENCES

1.  Robbins J, Langmore S, Hind J A, Erlichman M, Dysphagia research in the 21st century and beyond: proceedings from dysphagia experts meeting. J Rehabil Res Dev,2002; 39(4):543-8

2.  Paterson WG, Dysphagia in elderly. Can Fam Physician, 1996;42 925-32 .

3.  Morris H, Dysphagia in elderly-A management challenge for nurses. Br J Nurs, 2006;15(10):558-62.

4.  Hillel M,finestone, Linda S. Greeni-Finestone, Rehabilitation medicine:2.Diagnosis of dysphagia and its nutritional management for stroke patients. CMAJ.,2003;169(10);1041-4.

5.  Eggenberger SL. Nelms TP, Artificial hydration and neutrition in advanced Alzheimer’s disease; facilitating family decision-making. J Clin Nurs, 2004;13(6):661-7.

6.  Radford K, Woods H, Lowe D, Rogers SN, A UK Multi-centre pilot study of speech and swallowing outcomes following head and neck cancer. clin otolayngol Allied sci, 2004 ;29(4);376-81

7.  Heather Morris, Dysphagia in elderly. Country Doctor.

8.  P. Garcia-Peris, L. Paron, C. Velasco, C. de la Cuerda, M. Camblor, I. Breton, H. Herencia, et al. Long-term prevalence of oropharyngeal dysphagia in head and neck cancer patients; Impact on quality of life. Clin Nutr (2007), doi:10.1016/j.clnu.2007.08.006

9.  Takehisa Hanawa, Ryohko Maeda, Emi Muramatsu, Masahiko Suzuki, Masayasu Sugihara. New oral Dosage Form for Elderly Patients, III. Stability of Trichlormethiazide in silk fibroin gel and various sugar solutions. DDIP, 26(10),1091-7(2000)

10.  Gil ES, Frankowski DJ, Spontak RJ, Hudson SM. Swelling behaviour and morphological evolution of mixed gelation/silk fibroin hydrogels. Biomacromolecules.2005(6):3079-87.

11.  Gregory H. Altman; Frank Diaz, Caroline Jakuba, Tara Calabro, Rebecca L. Horan, Jingsong Chen, et al. Silk based biomaterials. Biomaterials 2003 24;(3),401-16

12.  Bayraktar O, Malay O, Ozgarip Y, Batigun A. Silk-fibroin as a novel coating material for controlled release of Theophylline. Eur J of pharm.biopharm. 2005, 60(3):373-81

13.  M. Fini, A. Motta, P. Torricelli, G. Giavaresi, N. Nicoli Aldini, M. Tschon, et al. The healing of confined critical size cacellous defects in the presence of silk fibroin hydrogel. Biomaterials2005 (26), 3527-36

14.  Xiaoquin wang, Esther wenk, xiao hu, silk coatings on PLGA and alginate microsperes for protein delivery. Biomaterials 2007(28),4161-69.

15.  Oguz Bayrahtar, ozge malay, yakin azgarip, aysegul batigun,silk fibroin as a novel coating material for controlled release of theophyllin. Eur.J. Pharm.Biopharm 2005(60), 373-81.

16.  Sangeeta k. cheema , Andrea s. gobin, Robyn Rhea, Silk fibroin mediated delivery of liposomal emodin to breast cancer cells. Int.J.pharm, 2007 (341), 221-29.

17.  Romics I, Molnar DL, Timberg G, Mrklic B, Jelakovic B, Koszegi G, et al.,The effect of Drotaverine hydrochloride in acute colicky pain caused by renal and ureteric stones.BJU Int;2003: 92(1): 92-6

18.  Bolaji OO, Onyeji CO, Ogundaini AO, Olugbade TA, Ogunbona FA. Pharmacokinetics and bioavailability of drotaverine in humans. Eur J Drug Metab Pharmacokinet, 1996;21(3):217-21.