Name Nimesh?

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Optimization and Evaluation of Transdermal formulation of low permeable drug
INTRODUCTION:
Transdermal drug delivery system has been in existence for a long time. In the past, the most commonly applied systems were topically applied creams and ointments for dermatological disorders. A recent approach to drug delivery is to deliver the drug into systemic circulation at predetermined rate using skin as a site of application by transdermal patch. A Transdermal drug delivery is a formulation or device that maintains the blood concentration of the drug within the therapeutic window using skin permeation as mode of delivery. Transdermal drug delivery promises many advantages over oral and/or intravenous administration, such as better control of blood levels, a reduced incidence of systemic toxicity, furthermore no hospitalization and absence of hepatic first-pass metabolism.
The drug is mainly delivered to the skin with the help of a transdermal patch which adheres to the skin. A Transdermal Patch has several components like liners, adhesive, drug reservoirs, drug release membrane, penetration enhancers, solubility enhancers, etc. which play a vital role in the release of the drug via skin. Various types of patches along with various methods of applications have been discovered to deliver the drug from the transdermal patch. Because of its great advantages, it has become one of the highly research field among the various drug delivery system.
Presser sensitive adhesive (PSA) is used as an adhesive for formulation of the transdermal patch for long term adhesion. PSA polymer is same as the simple polymer but only presser requirement during application. They are usually consisting of rubbery elastomer and modifying tackifiers. PSA have different solubility in solvent. According its solubility PSA is diluted. They are mainly thixotropic. PSA classified into three group polyisobutylene, acrylate and silicone polymer.
Adhesion property like peel, tack, shears and release force of the polymer is depended upon the viscoelastic property of the polymer. By the adding of the elastomer tackifiers control the adhesion property of the polymer. The tackifiers are divided in to two types: rosin type and hydrocarbon type. The rosin group consist of modified rosin, and there esters. Hydrocarbon type resin consists of the poly terpenes, modified hydrocarbon, phenolic resin and similar compound.
Penetration enhancers are used for optimization of diffusion of the drug from drug matrix. Permeation Enhancers are termed as accelerants that skin penetration by altering the lipid structure in viable epidermis and altering the drug solubility. Ideally, penetration enhancers reversibly reduce the barrier resistance of the stratum corneum without damaging viable cells some of the more desirable properties for penetration enhancers acting within the skin have been given as they should be non-toxic, non-irritating and non-allergenic.
Into the market of transdermal formulation, total five types of transdermal patches are available matrix type, reservoir type, micro sealed delivery devices, poroplastic film and macro molecular. Matrix and reservoir type of devices are mostly used for transdermal drug delivery system.
SCOPE:
Optimization and Evaluation of Transdermal formulation of low permeable drug
OBJECTIVE:
The prime objective of Transdermal dosage form is to achieve desired concentration of drug in blood or tissue, which is effective and non toxic at predetermined period of time.
The main objective of present work is to formulate transdermal PSA adhesive patch containing drugs antiparkinsonism, antihypertensive, narcotic analgesic or NSAID’S to give non toxic and patient compatible matrix system.
For development of polymeric Transdermal formulation, we suppose to construct following objectives:
 Selection of suitable drug candidate.
 To study the physiochemical and biological properties of drug candidate.
 To carry out drug-excipient compatibility studies.
 To develop polymeric transdermal patch using different PSA.
 Selection of the penetration enhancers.
 To develop in-vitro drug release of transdermal patch.
 To develop adhesion properties of transdermal patch.
 To carry stability study as per ICH Guidelines.
PLAN OF WORK:
To achieve these objectives, following plan of work would be execute:
(Plan of work divided in to five has comprising six month each and total duration will cover)
Phase-I: Literature search and review of Literature
• Review of Transdermal formulation
• Advantage of the transdermal formulation
Phase II: Procurement of material and preliminary studies
• Selection of the suitable model drug from above mention category
• Study of the physicochemical and pharmacokinetic properties of the drug
• Development of the analytical method
• Selection of the polymer and penetration enhancers
Phase III: Preformulation, compatibility studies and formulation development
• Drug-Excipient compatibility studies at accelerated condition
• Formulation of transdermal patch wit different type of penetration enhancers
• Development of suitable method for preparation of the transdermal patch
Phase IV: Evaluation of formulation drug delivery system
• Interaction studies
• Thickness of the patch
• Estimation of Drug
• Uniformity of dosage unit
• Drug release
• Shear Adhesion Test
• Peel Adhesion Test
• Thumb tack test
• In-vitro drug release study
• In-vitro skin permeation study
• Stability study as per ICH Guidelines
Phase V: Thesis writing and research paper publication
METHOD AND TECHNIQUE:
1) Selection of suitable drug candidate –
For the preparation of transdermal dosage form, the suitable drug candidate would be selected on the basis of duration of action and half-life and physico-chemical properties of the drug.
2) Selection of PSA –
The polymer for study would be selected on the basis of biocompatibility, physical and chemical properties and stability.
3) Preparation of transdermal patch –
Matrix type of transdermal patch would be prepared using suitable polymer by coating method.
4) Evaluation of transdermal patch –
Prepared transdermal patch would be evaluated for following parameters.
1) Chemical and physical compatibility studies
• FTIR technique
• X Ray Diffraction technique
• UV visible or HPLC technique
2) Thickness of the patch
• Digital micrometer
3) Estimation of Drug
• Extraction method in suitable media and analyzed by UV spectrophotometer.
4) Uniformity of dosage unit
5) In-Vitro drug release
• Dissolution technique as per United state pharmacopeia
• UV visible or HPLC Method

6) Shear Adhesion Test
• By Loyd instrument
7) Peel Adhesion Test
• By Loyd instrument
8) Take test
• By Loyd instrument
9) Thumb tack test
10) In-vitro skin permeation study
• In-vitro skin permeation study would be carried out by using Franz diffusion cell.
11) Stability study as per ICH Guidelines
• Stability studies would be carried out to determine the effect of varying atmospheric condition.
CHAPTER SCHEME:
Chapter I Introduction
a) Types of transdermal formulation
b) Advantages of transdermal patch
c) Components of the transdermal patch
d) Types of transdermal patch
e) Technologies of transdermal patch
f) Information on the Research envisaged

Chapter II : Design of Transdermal patch
Selection of model drug candidate based on physiochemical properties and biopharmaceutical parameters.
a) Selection of excipients for dosage form development and their characterization.
b) Drug-excipient compatibility studies.
Chapter III: Formulation of Transdermal patch
a) Effect of Process variables on the dosage form.
Chapter IV: Evaluation of Dosage Form
Compatibility studies
Thickness of the patch
Estimation of Drug
Uniformity of dosage unit
Drug release
Shear Adhesion Test
Peel Adhesion Test
Thumb tack test
In-vitro drug release study
In-vitro skin permeation study
Stability study as per ICH Guidelines
Chapter V: Results and Discussion
It would be include information on the drug release profiles and skin permeation, effect of the different penetration enhancers, effect of various process variables on the drug release profiles.
Chapter VI : Conclusion based on the results and discussion.
Chapter VII : References

REFERENCES:

1 Rakesh P. Patel, Ashok H. Baria. Formulation and Evaluation Considerations of Transdermal Drug Delivery System. International Journal of Pharmaceutical Research, 2011, Volume 3, Issue 1, 1-9.
2 J. Ashok kumar, Nikhila pullakandam, S.Lakshmana prabu, V.Gopal. Transdermal Drug Delivery System: An Overview. International Journal of Pharmaceutical Sciences Review and Research, Volume 3, Issue 2, July – August 2010; Article 009.
3 Ashok K. Tiwary, Bharti Sapra and Subheet Jain. Innovations in Transdermal Drug Delivery: Formulations and Techniques. Recent Patents on Drug Delivery & Formulation 2007, Vol. 1, No. 1.
4 BG Desai, AR Annamalai, B Divya, BM Dinesh. Effect of enhancers on permeation kinetics of captopril for transdermal system. J. Pharm. Sci. 1982 ; 71, 1323-1328.
5 Hadgraft J, Lane ME. Skin permeation: The years of enlightenment. Int J Pharm 2005;305:2-12.
6 Bruton LL, Laza JS, Parker KL. Goodman Gilman's: The pharmacological basis of therapeutics. New York: McGraw Hill Medical Publishing Division; 2006. p. 801-10.
7 Martindale: The complete drug reference. The enhancement effect of surfactants on the penetration of lorazepam through rat skin. 33 rd ed. London: Pharmaceutical Press; 2007. p. 853-4.
8 S. Jayaprakash, S Mohamed Halith, Pu Mohamed Firthouse, Yasmin, M Nagarajan. Preparation and Evaluation of Celecoxib Transdermal Patches. Pak. J. Pharm. Sci., Vol.23, No.3, July 2010, pp. 279-283.
9 Stanley Scheindlin. Transdermal Drug Delivery: PAST, PRESENT, FUTURE by molecular intervention.
10 Gullick DR, Pugh WJ, Ingram MJ, Cox PA, Moss GP. Formulation and characterization of a captopril ethyl ester drug-in-adhesive-type patch for percutaneous absorption. Drug Dev Ind Pharm. 2010 Aug; 36 (8):926-32.
11 Jain P, Banga AK. Inhibition of crystallization in drug-in-adhesive-type transdermal patches. Int J Pharm. 2010 Jul 15;394(1-2):68-74. Epub 2010 May 9.

Signature of Candidate Signature of Supervisor
(Nimesh Goswami)

Date:
Place: Ahmedabad