RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR M.PHARM
DISSERTATION
1. / Name of the candidateand address. / T. RANVEER
S/o T. Hanmanth Rao, H.No:- 6-25-188, Near Aagaiah Hotel, Dubba, Nizamabad, Andhra Pradesh, Pin: 503002.
2. / Name of Institution / RRK’S Collage of Pharmacy, Naubad Bidar-585402.
3. / Course of study and subject. / M.PHARM (Pharmaceutics).
4. / Date of admission to the course /
29-07-2011
5. / Title of Topic: / FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF DILTIAZEM HYDROCHLORIDE
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the Study:
.
The term sustain release is known to have exist in medical and pharmaceutical literature for many decades it has been constantly used to describe of pharmaceutical dosage form formulated to retard the release the therapeutic agents such that its appearance in systemic circulation is delay and or prolonged and its plasma profile is sustained in duration. The onset of its pharmacologic action is often delay and duration of therapeutic effect is sustained1. Sustained release dosage form is mainly designed for maintaining therapeutic blood or tissue levels of the drug for extended period of time with minimized local or systemic adverse effects. Economy and greater patient compliance are other advantages. Sustained release dosage forms would be most applicable for drugs having low therapeutic indices and short elimination half lives. Matrix tablets are easy to prepare and they are cost effective and exhibit predictable release behavior .
Diltiazem hydrochloride is a white , odourless, crystalline powder, or small crystals.
Freely soluble in water, in chloroform, in formic acid and in methyl alcohol; sparingly soluble in dehydrated alcohol; insoluble in ether2. Diltiazem hydrochloride (DHL), a potent calcium channel blocker, is used in the management of angina pectoris, arrhythmia and hypertension. It has small plasma half-life (t1/2 = 3.5 h) and usual dose is 30 mg thrice daily. As a result of its short half-life, the development of oral sustained release formulation of this drug is highly desirable, so as to improve therapeutic effects with minimum side effects and improved patient compliance.3
6.2 Review of Literature:
· B.Mishra, A.Bansal and C.Sankar 3. The present study aimed to formulate and evaluate hydrophilic matrix tablets of diltiazem hydrochloride to achieve a controlled and sustained drug release with reduced frequency of drug administration, reduced side effects and improved patient compliance. Matrix tablets of diltiazem hydrochloride were prepared using polymers like hyroxypropylmethylcellulose (HPMC K15, HPMC K4), sodium carboxymethylcellulose (SCMC) and Guar gum, and different diluents like lactose, starch, microcrystalline cellulose.
· Ibrahim M. El-Bagory, Nahla Brakat, Mahmoud El-Badry, Mohamed A. Ibrahim and Fouza El-EnazI 4. The deformation mechanism of pharmaceutical powders, used in formulating directly compressed matrix tablets, affects the characteristics of the formed tablets. Three polymers of different deformation mechanisms were tested for their impact on Deltiazem (DZ) directly compressed tablets namely Kollidon ® SR (KL SR, plastic deformation), Ethylcellulose (EC, elastic deformation) and Carnauba wax (CW, brittle deformation) at different compression forces. However, tablets based mainly on KL SR, the plastically deformed polymer (DZ1)exhibited the highest hardness values compared to the other formulae which based on either blends of KL SR with CW, the very brittle deformed polymer.
· Mohammad Borhan Uddin et al 5. To investigate the effects of various physicochemical factors such as compression force, pH of dissolution medium, amount of HPMC (hydroxyl propyl methyl cellulose) on Eudragit NE 30D and Eudragit RS 30D based matrix tablet of Theophylline.
· Madhusmruti Khandi et al 6. Sustain release matrix formulation of Propranolol hydrochloride were prepared by using both hydrophilic and hydrophobic polymers and also to investigate their effect on drug release. Matrix tablets were prepared by direct compression method using different concentration of HPMC and Ethyl cellulose.
· K. P. R. Chowdary et al 7. Diclofenac matrix tablet were formulated employing olibanum and its resins and carbohydrate fractions in different concentrations and the tablets were evaluated for various tablet characters including drug release kinetics and mechanism. Diclofenac matrix tablets formulated employing olibanum and its resin component provided slow and controlled release of diclofenac over more than 24 hr. even at very low concentrations, 1 and 2% w/w in the formula. Drug release from the matrix tablets was by Fickian diffusion and followed first order kinetics. Diclofenac release from some of the formulated tablets was comparable to that of Voveran SR tablet.
· P. G. Yeole et al 8. Sustained release matrix tablets of diclofenac sodium, were developed by using different drug: polymer ratios. Xanthan gum was used as matrix former, and microcrystalline cellulose as diluents. All the formulations showed compliance with pharmacopoeial standards.
· Md.selim Reza, et al 9 . The effect of plastic hydrophilic and hydrophobic polymer and their content level on the release profile of drug from matrix system. As the physico-chemical nature of the active ingredients influence the drug retarding ability of these polymer.
· Kale, k. Santhi, sajeeth C.I. and CH. Naveen Kumar 10.The present study aimed to formulate and evaluate hydrophilic matrix tablets of Diltiazem hydrochloride to achieve a controlled and sustained drug release with reduced frequency of drug administration, reduced side effects and improved patient compliance.
· Martins Emeje ,et al 11. Oral sustained release matrix tablets of zidovudine were prepared using different , proportion and blend of Carbopol and plant gum obtain from Abelmoschus Esculentus (AEG) The effect of various formulation factors like polymer proportion, polymer type and pH of the dissolution medium on the in vitro release of Drug. Drug from matrix tablets of Ziduvudine containing blend AEG and Carbopol demonstrate the Advantage of blending a natural and Synthetic polymer over single polymer use.
· V.C. Modi and DR. A.K.Seth 12. Sustained releases tablets of Diltiazem hydrochloride were formulated by employing hydroxypropyl methylcellulose (HPMC K100 M) and the sustained release behaviour of the fabricated tablets was investigated. Sustained release matrix tablets containing 120 mg Diltiazem hydrochloride were developed using different drug: polymer (HPMC K100 M) ratios. Tablets were prepared by wet granulation technique.
6.3 Objectives Of study:
· To develop a matrix tablet formulation of bronchodilator drug with polymer that will provide sustain drug release for prolong period.
· To evaluate prepared products for their quality control parameters
· To carry out the compatability studies.
· Stability studies on selected formulations.
7 MATERIALS AND METHODS:
7.1. Source of data:
· Internet.
· R.G.U.H.S library, Bangalore.
· International pharmaceutical abstract.
7.2. Method:
· The sustain release matrix tablet of drug will be formulated by direct compression method or wet granulation method by using different polymers eg. HPMC, Ethyl cellulose, carbapol, PVP, Eudragit, Natural polymer, etc. Lubricant eg. Magnesium stearate, Talc etc.
7.3 Evaluation of matrix tablets :
A) To evaluate the prepared tablets for physical parameters like weight variation , Friability, hardness, thickness, swelling index and drug excipient interactions (IR – Spectroscopy ) etc.
B) Estimation of drug Content: The drug content of the formulations will be determined spectro-photometrically at 237 nm 12
C) Drug release study: The Dissolution study will be carried out in USP tablet Dissolution test apparatus (paddle type) using phosphate buffer of pH 7.4 at 100 rpm. 12
7.4 Does the study require any investigation or intervention to be conducted on patient or Other human or animals? If so please describe briefly)
------Not under the plan of work------
7.5 Has ethical clearance been obtained from your institution in case of
------Not under the plan of work------
8. LIST OF REFERANCEs :
1. Yie W.Chein. “Concept and systemic design for the rate controlled drug delivery”. Chap-I “Novel drug delivery system”, 2nd Edition, Vol 50, :1-42.
2. Martindale.“ The complete drug referance” 34th Edition ,: 900-903.
3. B.Mishra, A.Bansal and C.Sankar, “Development and in vitro evaluation of hydrophilic matrix tablet of Diltiazem hydrochloride”. Acta Pharma Turcica 47,(2005) 115-126.
4. Ibrahim M. El-Bagory, Nahla Brakat, Mahmoud El-Badry, Mohamed A. Ibrahim and Fouza El-Enazi, . “Effect of polymer blend on Diltiazem HCL matrix tablets prepared by direct compression”. J. Pharm. Sci & Technology Vol. 2 (7), 2010, :252-268.
5. Mohammad Borhan Uddin et al. “Investigation of the effects of different physicochemical parameters on in vitro release kinetics of theophylline from Eudaragit NE 30 & Eudragit RS 30D matrix Tablets”. J. Pharm. Sci & Re., Vol.2 (4) , 2010 , :240-246.
6. Madhusmruti Khandi et al. “ Development of Propranolol hydrochloride matrix tablet : An Investigation on effects of combination of hydrophilic and hydrophobic matrix formers using Multiple comparison analysis”. Int.J. Pharm. Sci., Vol. 1(2), 2010, Article 001, :1-7.
7. K. P. R. Chowdary et al. “Evaluation of olibanum and its resins as rate controlling matrix for controlled release of Diclofenac”. Indian J. Pharm. Sci., Vol. 68(4), 2006, : 497-500.
8. P. G. Yeole et al. “ Design and evaluation of Xanthum gum based sustained released matrix tablets of Diclofenac sodium”. Indian J. Pharm. Sci., Vol. 68(2) , 2006, : 185-189.
9. Md.selim Reza, et al. “ Comparative evaluation of plastic, hydrophobic & hydrophilic polymers as matrices for controlled release drug delivery”. J.Pharm. Pharmaceut. Sci., Vol. 6(2), 2003 , :274-291.
10. Kale, k. Santhi, sajeeth C.I. and CH. Naveen Kumar, “Design and characterization of diltiazem hydrochloride sustained release matrix tablets”. Int. J. Pharm. Bio Sci., Vol.2(2) Apr-jan (2011) :714-721.
11. Martins Emeje ,et al.“Oral sustained release tablet of zidovudine using binary blends of natural & synthetic polymers.” Biol.Pharm.Bull., Vol .33 (9), 2010, :1561-1567.
12. V.C. Modi and DR. A.K.Seth, “Formulation and evailuation of Diltiazem sustained release tablets”. Int. J. Pharm. Bio Sci., Vol.1/Issue-3/Jul-Sep.2010 : 1-10.
9 / Signature of the candidate10. / Remarks of the Guide
11. / Name and Designation of
(in block letters)
11.1 Guide
11.2 Signature / DATTATREYA. B. UDGIRKAR Professor.
RRK’S College Of Pharmacy, Naubad,
BIDAR.
12. / Name and Designation
(In block letters) / Not Applicable
12.1 Co – Guide
12.2 Signature
/
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13. / 13.1 Remarks of the Chairman and Principal.
13.2 Signature. / Dr . K. SREENIVASA RAO
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