RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1. |Name of the candidate & Address |IZHAR KASID SHAIKH ABDUL GAFFAR |

| |(In block letters) |C/O LUQMAN COLLEGE OF PHARMACY, |

| | |POST BOX NO: 86, BEHIND P & T COLONY, |

| | |OLD JEWARGI ROAD, |

| | |GULBARGA – 585102 |

|2. |Name of the Institution |LUQMAN COLLEGE OF PHARMACY, GULBARGA-585102 |

|3. |Course of study and subject |M.PHARM (PHARMACEUTICS) |

|4. |Date of admission to course |20 MAY 2009 |

|5. |Title of the topic |FORMULATION AND EVALUATION OF BILAYER TABLET OF LISINOPRIL AND GLICLAZIDE |

|6. 6.1 |Brief resume of the intended work |

| |Need for the study : |

| |In recent times, various developed and developing countries move towards combination therapy for treatment of various diseases and disorders |

| |requiring long term therapy such as hypertension and diabetes. Combination therapy have various advantages over monotherapy such as problem of |

| |dose dependent side effects is minimized, a low dose combination of two different agents reduces the dose related risk, the addition of one |

| |agent may potentiate effects of other agent. Using low dosage of two different agents minimizes the clinical and metabolic side effects that |

| |occur with maximal dosage of individual component of the combined tablet and thus dose of the single components can be reduced1. Bilayer tablets|

| |are novel drug delivery systems where combination of two or more drugs in a single unit having different release profiles improves patient |

| |compliance, prolongs the drugs action, avoid saw tooth kinetics resulting in effective therapy along with better control of plasma drug level. |

| |Bilayer tablet are very common dosage form for drugs such as captopril, metoprolol, amoxicillin and potassium clavuanate, propranolol |

| |hydrochloride, bambuterol hydrochloride2. JNC VI recognized the value of combination therapy and suggested that combining drug with different |

| |modes of action will often allow smaller doses of drugs to be used to achieve control and minimize the potential dose dependent side effects. |

| |JNC VI recommended that the combination of a low dose of two drugs in fixed dose combination is an appropriate choice for initial treatment of |

| |any chronic disease3. Hypertension occurs with twice the frequency in diabetic compared with non diabetic population and upto 50% of patient |

| |with type-II diabetes mellitus became hypertensive. Therefore hypertension is one of the major risk factor for diabetic nephropathy and possibly|

| |for diabetic retinopathy. Angiotensin converting enzyme(ACE) inhibitor have been particularly recommended in patient with nephropathy as they |

| |decrease protienuria and preserve glomerular filtration rate in diabetic patient and they also potentiate the effect of sulphonyl urea and |

| |biguanides4. |

| |Lisinopril is an ACE inhibitors which is widely used in the treatment of hypertension in diabetic patients and also play a vital role in the |

| |management of diabetes complication such as diabetic nephropathy. Half life of lisinopril is 11-12 hours and given in a dose of 2.5–10 mg |

| |daily5. Gliclazide is a second generation sulphonyl urea, an antihyperglycemic agent that improves glucose tolerance and enhances peripheral |

| |insulin sensitivity in patient with type-II diabetics. Also the effect of gliclazide is potentiated by the lisinopril. Half life of gliclazide |

| |is 10-12 hours and given in a dose of 80 mg daily6. |

| |Hence in the present work an attempt will be made to formulate bilayer tablet of lisinopril and gliclazide as bimodal release system to manage |

| |diabetes mellitus and to overcome diabetic induced complications such as hypertension and nephropathy. |

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|6.2 |Review of literature: |

| |Extensive literature survey was carried out on the proposed research work by referring various scientific journals, internet and helinet |

| |facilities. |

| |Yeole PG et.al1., study proved that bilayer tablet technology could be successfully used for the management of cardiovascular diseases by fixed |

| |dose combination of sustained release metoprolol tartarate and immediate release hydrochlorothiazide. Nagaraju R and Kaza R2., formulate and |

| |evaluate bilayer sustained release tablet of salbutamol and theophylline using polymer such as HPMC K4M, HPMC K100M, xanthum gum, ethyl |

| |cellulose and HPMC-P. Atram SC et.al3., prepared bilayer tablets of antihypertensive drugs and concluded that drug release of amlodipine |

| |besylate and metoprolol succinate follow non fickian diffusion and super class II transport. Shirwaikar AA et.al7., prepared sustained release |

| |bilayer tablet of diltiazem using insoluble matrix system and concluded that bilayer tablets shows bimodal release of diltiazem HCl. Chandira MR|

| |et.al8., worked on design, development and evaluation of immediate release atorvastatin and sustained release gliclazide tablet using two grades|

| |of HPMC and explained that combination of both drug in the form of bilayered tablet can be used effectively for the treatment of diabetes in |

| |obese patient. Nirmal J et.al9., formulate and evaluate bilayer tablet of Atorvastatin calcium as immediate release and nicotinic acid as |

| |sustained release for the treatment of hyperlipidemia. Amrutkar JR et.al10., formulate bilayer tablet of metformin and gliclazide for the |

| |treatment of diabetes and concluded that combination of hydrophilic and hydrophobic polymer with melt granulation technique is an excellent cost|

| |effective technique for achieving sustained release pattern. Uttam M et.al11., formulated and optimized bilayer antidiabetic matrix tablet |

| |containing metformin HCl and glipizide for the effective management of diabetes mellitus. Patra CN et.al12., design and evaluate sustained |

| |release bilayer tablets of propranolol HCl and concluded that bilayer tablet showed an initial burst effect to provide loading dose followed by |

| |sustained release. |

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|6.3 |Objectives of the Study |

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| |The aim of the present work is to formulate and evaluate bilayer tablet of lisinopril and gliclazide with the following objectives: |

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| |Preparation of immediate release layer of Lisinopril using superdisintegrants by direct compression methods. |

| |Preparation of sustained release layer of Gliclazide by using hydrophilic, synthetic and semisynthetic polymer by wet granulation method. |

| |Compression of immediate release layer and sustained release layer to make a bilayer tablet. |

| |Physicochemical characterization of bilayer tablet by IR spectroscopy. |

| |Evaluation of tablet parameter such as hardness, thickness, friability, weight variation, drug content, for both immediate release and sustained|

| |release layer separately. |

| |In Vitro release study of immediate release and sustained release layer separately. |

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|7. |Material and Methods |

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| |Materials : |

| |The materials to be used in the present studies include, |

| |Drug : Lisinopril (Antihypertensive) |

| |Gliclazide (Antidiabetics) |

| |Polymer : |

| |For immediate release layer: - Super disintegrants like sodium starch glycolate, cross carmellose sodium etc. |

| |For sustained release layer: -Synthetic and semi synthetic hydrophilic polymer like sodium carboxy methyl cellulose, hydroxyl propyl methyl |

| |cellulose, hydroxyl propyl cellulose. |

| |Equipments : |

| |UV/ Visible spectrophotometer (Shimadzu 1700) |

| |IR – spectrophotometer – JASCO FT/IR 5300 |

| |Single Pan electronic balance (Dhona equipment pvt ltd Kolkata) |

| |Digital balance (Shimadzu corporation BL-2204) |

| |Digital type pH meter (elico LT122) |

| |Electrolab dissolution apparatus (USPXIII) |

| |Tablet compression machine (Rimek) |

| |Monsanto Hardness tester. |

| |Roche Friability apparatus |

| |Hot air oven |

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|7.2 |Methods : |

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| |UV spectrophotemetric estimation of Lisinopril drug. |

| |UV spectrophotemetric estimation of Gliclazide. |

| |Immediate release layer will be prepared using different superdisintegrant by Direct Compression Method. |

| |Sustained release layer will be prepared by wet granulation method. |

| |Evaluation of tablet parameter like hardness, thickness, friability, weight variation, drug content and in vitro dissolution studies for both |

| |layers separately. |

| | |

|7.3 |Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please describe |

| |briefly. |

| |----------- Not under the plan of our work ----------------- |

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

| |------------ Not applicable --------------- |

|8. |List of Reference |

| |Yeole PG, Karande AD, Dhoke SV. Formulation and evaluation of bilayer tablet with antihypertensive drugs having different release pattern. Ind |

| |Drugs.2006; 43(1): 44-50. |

| |Nagaraju R, Kaza R. Formulation and evaluation of bilayer sustained release tablets of salbutamol and theophylline. Int J Pharma Sci |

| |NanoTech.2009;2(3):638 -.646. |

| |Atram SC et.al., Formulation of bilayer tablet containing metoprolol succinate and amlodipine besylate for antihypertensive therapy. J Pharm |

| |Research.2009;2(8):1335-1347. |

| |Sweetman SC (Eds), Martindale:The complete drug reference, 33rd edition. Great Britain, Pharmaceutical press.2002: 322,921. |

| | |

| | |

| |Shirwaikar AA, shrinatha A. Sustained release bilayer tablet of diltiazem hydrochloride using insoluble matrix system. Ind J Pharm |

| |Sci.2004;6(4):433-437. |

| |Chandira MR, Jayakar B, Pashupathi A, Chakrabarty BL, Maurya P. Design, development and evaluation of immediate release atorvastatin and |

| |sustained release gliclazide tablets. J Pharm Research.2009;2(6):1039-1041. |

| |Nirmal J et.al., Bilayer Tablets of Atorvastatin Calcium and Nicotinic Acid: Formulation and Evaluation,. Chem Pharm Bull.2008;56(10):1455 |

| |-1458. |

| |Amrutkar JR, Kasalkar MG, Shrivastav VG, Yeole PG. Bilayer tablet formulation of metformin hydrochloride and Gliclazide: A novel approach in the|

| |treatment of diabetics. Int J Pharm Research Dev.2009;1(5):7-15. |

| |Mandal U, Pal TK. Formulation and in vitro studies of a fixed dose combination of a bilayer matrix tablet containing metformin as sustained |

| |release and glipizide as immediate release.Drug Dev Ind Pharm.2008;(34):305-313. |

| |Patra CN, Arethi BK, Pandit HK, Singh SP. Design and evaluation of sustained release bilayer tablets of propranolol hydrochloride. Acta |

| |Pharm.2007;57:479–489. |

| |Kartheikeyini CS, Jayaprakash S, Abirami A, Halith MS. Formulation and evaluation of aceclofenac sodium bilayer sustained release tablets. Int J|

| |ChemTech Research.2009;1(4):1381-1385. |

| |Shiyani B, Gattani S, Surana S. Formulation and evaluation of bilayer tablet of metaclopramide hydrochloride and ibuprofen. AAPS |

| |PharmSciTech.2008;9(3):818-827. |

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|9. |Signature of Candidate | |

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| | |[IZHAR KASID SHAIKH] |

|10. | Remarks of Guide | |

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|11. | Name & Designation of (in block letters) | |

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| |11.1. Guide |MR. M.A. SALEEM |

| | |ASST. PROFESSOR, |

| | |DEPARTMENT OF PHARMACEUTICS, |

| | |LUQMAN COLLEGE OF PHARMACY, |

| | |GULBARGA. |

| |11.2. Signature | |

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| |11.3 Co-Guide |aeJAZ ahmed |

| | |m. pharm |

| | |LECTURER, |

| | |LUQMAN COLLEGE OF PHARMACY, |

| | |GULBARGA. |

| |11.4 Signature | |

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|12. |12.1 Remark of the Chairman and Principal | |

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| |12.2 Signature | |

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