FORMULATION AND EVALUATION OF RISPERIDONE EXTENDED RELEASE DOSAGE FORM BY USING DIFFERENT ENTERIC POLYMERS
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1 Available online at International Journal of Trends in Pharmacy and Life Sciences Vol. 1, Issue: 3, 215: FORMULATION AND EVALUATION OF RISPERIDONE EXTENDED RELEASE DOSAGE FORM BY USING DIFFERENT ENTERIC POLYMERS Yaswanth Kumar Devarapalli*& K. Anil Kumar Sarada College of Pharmaceutical Sciences Kondakavuru, Guravaiah Palem, Narasaraopet , Guntur, A.P. ABSTRACT Risperidone belongs to the class of atypical antipsychotics. It is a dopamine antagonist possessing antiserotonergic, antiadrenergic and antihistaminergic properties. The approach of present study is to compare the release profile of our formulation with reference product. Core tablets were prepared with different concentrations of binder, lubricant, Disintegrant and found the physical parameters and from that have optimized the concentration of binder, lubricant, Disintegrant and formulated the core tablet by using wet granulation method due to its poor flow properties. To that core tablet barrier coating was given up to 1.5 % weight build up and then they are enteric coated with initially 15 %. And then by increasing the enteric coating build up for different formulations, finally compared the dissolution with Reference product. F6A was found to be best of all the formulations showing drug release matching with the Reference product so to that formulation all the tests were done for conformation. The identified formula shall be utilized for the formulation development and other studies for successful launching of the product. Key Words: Risperidone, Proton pump-inhibitor, peptic ulcer, Extended Release tablets, Enteric coating polymer. *Corresponding Author: Yaswanth Kumar Devarapalli Sarada College of Pharmaceutical Sciences Kondakavuru, Guravaiah Palem, Narasaraopet ,Guntur, A.P. E.Mail:yaswanthnzd@gmail.com Received: 25/7/215 Revised: 23/9/215 Accepted: 3/9/215 INTRODUCTION An Extended Release dosage form is designed to release the drug at a time other than promptly after administration. Dosage forms can be designed to modify the release of the drug over a given time or after the dosage form reaches the required location. Extended Release dosage forms are designed to provide spatial placement or temporal targeted delivery of a drug to the distal human gut. Spatial placement relates to targeting a drug to a specific organ or tissue, while temporal delivery refers to desired rate of drug release to target tissue over a specified period of time [1]. The primary aim of using extended release products is to protect the drug from gastric fluids, to reduce gastric distress caused by drugs particularly irritating to the stomach or to facilitate gastrointestinal transit for drugs that are better absorbed from intestine. Extended Release products are typically enteric-coated or targeted to the colon. Risperidone belongs to the class of atypical antipsychotic. It is a dopamine antagonist possessing antiserotonergic, antiadrenergic and antihistaminergic properties. After administration of a single or multiple oral 4 mg doses of Risperidone Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
2 Extended-Release Tablets, the peak plasma concentration of Risperidone was achieved in approximately 2.5 hours, and Cmax was 2.5 μg/ml Risperidone undergoes little first-pass metabolism, resulting in an absolute bioavailability of approximately 77% [2]. Risperidone absorption is not affected by concomitant administration of antacids. Administration of Risperidone Extended-Release Tablets with food may delay its absorption up to 2 hours or longer; however, the Cmax and the extent of Risperidone absorption (AUC) are not altered. Thus, Risperidone Extended-Release Tablets may be taken without regard to timing of meals [3]. MATERIALS AND METHODOLOGY: Materials: Risperidone was obtained as a gift sample from Halmak pvt ltd, Hyderabad. Mannitol, Crospovidone, carbonate anhydrous, Hydroxy Propyl Cellulose were received from goldfish pharmaceuticals, Secunderabad. Purified Talc, Calcium Stearate, Zein F 4 [Regular], and Poly (methacylic acid-co-ethyl acrylate, Titanium Dioxide, Triethyl Citrate, Isopropyl Alcohol were purchased from hippo labs Hyderabad [4]. Methodology: Preparation of Standard Curve: Standard plot using 6.8 ph phosphate buffer: Accurately weighed quantity(1mg) of Risperidone was taken and dissolved in 1 ml of water in standard flask and made up to 1ml with phosphate buffer ph 6.8 (1ug/ml concentration). From this 1 ml was taken and made up to 1 ml with phosphate buffer ph 6.8,it was used as stock solution. From the above stock solution.2,.4,.6,.8, 1., 2., ml were taken and diluted with phosphate buffer ph6.8 to produce concentration of 2ug/ml, 4ug/ml, 6ug/ml, 8ug/ml, 1ug/ml, 2ug/ml, The absorbance of the resulting solutions was measured at 29nm using UV-spectrophotometer with phosphate buffer ph6.8 as blank [5]. Standard plot using.1 N Hcl: Accurately weighed quantity (1mg) of Risperidone was taken and dissolved in 1 ml of water in standard flask and made up to 1ml with.1n Hcl (1ug/ml concentration). From this 1 ml was taken and made up to 1 ml with.1n Hcl,it was used as stock solution. From the above stock solution.2,.4,.6,.8, 1., 2., ml were taken and diluted with.1n Hcl to produce concentration of 2ug/ml, 4ug/ml, 6ug/ml, 8ug/ml, 1ug/ml, 2ug/ml, the absorbance of the resulting solutions was measured at 29nm using UV-spectrophotometer with.1n Hcl as blank [6]. Drug excipient compatibility studies: Drug is mixed with excipients in different ratio. These mixtures were kept in a glass amber colored vials and packed properly. These vials are exposed to 4 c / 75%RH. Observations for physical appearance are made at zero weeks, 2 week, and 4week, the samples were withdrawn for analysis [7]. Formulation Development of Risperidone Extended release tablets: Based on preformulation data wet granulation method was selected due to poor flow properties and other characteristics from preformulation and different formulation trials are tabulated below. The Excipients selected based on compatibility study and are commonly used excipients. In the trials different binder, Lubricant, Disintegrant concentrations is taken and compressed the tablets at different hardness conditions and observer the changes [8]. Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
3 Table 1: Formula for preparation of Core tablet of Risperidone Ingredients F 1 F2 F3 F4 F5 F6 F7 F8 F9 Core tablet Risperidone ** Mannitol Carbonate Anhydrous Hydroxy Propyl cellulose Cross Povidone Calcium Stearate Purified Talc Purified Water q.s q.s q.s q.s q.s q.s q.s q.s q.s TOTAL Note:**Risperidone, Sesquihydrate 45.1 mg is equivalent to 4 mg of Risperidone From the above core tablet formulations we have optimized the concentration of binder, lubricant, Disintegrant and found the best formula for coating. Formulation of Risperidone Core Tablet with optimized formulation: Table 2: Formulation of Risperidone Core Tablet with optimized formulation S.NO Ingredients Mg / Tab 1 Risperidone Mannitol Carbonate Anhydrous 8. 4 Hydroxyl propyl cellulose Cross Povidone Calcium Stearate Purified Talc Purified water 2. Total 15 Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
4 Formula for coating of Risperidone tablets: Table 3: Formula for coating of Risperidone tablets: Formulations F1A F2A F3A F4A F5A F6A F7A F8A Sub Coating: Zein Eudragit L Iso Propyl Alcohol Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S Purified Water Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S Enteric Coating Eudragit L Tri Ethyl Citrate Purified Talc Titanium Dioxide Iso Propyl Alcohol Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S Evaluation of Core Tablets: Thickness: Twenty tablets from the representative sample were randomly taken and individual tablet thickness was measured by using digital vernier caliper. Average thickness and standard deviation values were calculated [9]. Hardness: Tablet hardness was measured by using Monsanto hardness tester. From each batch six tablets were measured for the hardness and average of six values was noted along with standard deviations [1]. Friability Test: From each batch, ten tablets were accurately weighed and placed in the friability test apparatus (Roche friabilator). Apparatus was operated at 25 rpm for 4 minutes and tablets were observed while rotating. The tablets were then taken after 1 rotations, dedusted and reweighed. The friability was calculated as the percentage weight loss. % Friability was calculated as follows [11] % Friability = (W 1 W 2 ) x 1/W 1 Friability values below 1 % are generally acceptable. Weight Variation Test: To study weight variation individual weights (W I ) of 2 tablets from each formulation were noted using electronic balance. Their average weight (W A ) was calculated. Average weights of the tablets along with standard deviation values were calculated [12]. % weight variation = (W A W I ) x 1/ W A Dissolution Studies: The dissolution was carried out for different experimental trials and also for the innovator. The various results that are obtained are tabulated below. Dissolution studies are carried out in the Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
5 following Medias [13]. Acidic Stage: Medium Type of apparatus :.1N HCl : USP - II (paddle type) RPM : 1 Volume : 9ml Temperature : 37ºC±.5 Time : 2hrs Mobile phase: 1. Mix ph 6.8 buffer and Acetonitrile in the ratio of 65: 35 v/v respectively. 2. Degas in a sonicator for about 1 minutes. Calculations: Quantity of Risperidone A X Ws X 2 X P X1 Retained in portion of tablets = As % of labeled amount B X 25 X L x 1 A = Peak area of Risperidone for Test preparation. B = Peak area of Risperidone for Standard preparation. Ws = Weight of Risperidone, Sesquihydrate standard taken, in mg for standard preparation. L = Labeled amount of Risperidone (C 16 H 14 F 2 N 3 O 4 S) in mg per tablet. P = Potency of Risperidone, sesquihydrate (C 16 H 14 F 2 N 3 O 4 S Na. 1 1/2.H 2 O) Standard calculated as Risperidone (C 16 H 14 F 2 N 3 O 4 S). % of drug release in.1n Hydrochloric acid = % of Assay - % of drug retained in tablet after 2 hours of run in.1n Hydrochloric acid [14]. RESULTS AND DISCUSSION API Charectariasation: Initial weight of API taken = 2 gm Initial volume of API taken = 65 ml Volume after 5 tap Volume after 75 tap = 47 ml = 47 ml Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
6 Table 4: Results of B.D, T.D, C.I, H.R, Angle of Repose Parameter Value Unit LOD 1.5 % w/w BD.3 gm/ml TD.42 gm/ml CI % HR Angle of repose 32.3 ºc Sieve Analysis: Table 5: Sieve Analysis of API Sieves Initial weight After Difference weight Retained Percentage Cumulative Percentage # # # # # # #Pan Solubility: Table 6: Solubility of drug in buffer solutions Medium Solubility.1 N Hcl.98 mg/ml ph 2.1 SGF ph 4.5 Acetate Buffer ph 5. Acetate Buffer ph 6.8 Phosphate Buffer ph7.2 Phosphate Buffer 1.41 mg/ml.256 mg/ml.324 mg/ml mg/ml 4.97 mg/ml ph 8. Phosphate Buffer >16.1 N NaoH >16 Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
7 Drug excipient compatibility studies: Table 7: Result of Compatibility Study Name of the Excipient Ratio Initial Final observation conclusion Risperidone White to off white 4 C/75% RH 2 nd week 4 th week White to off white White to off white Compatible Risperidone : Cross povidone 1 :1 white white white Compatible Risperidone : HPMC 1:1 White to off white White to off white White to off white Compatible Risperidone : Mannitol 1:5 white white white Compatible Risperidone :Carbonate Anhydrous 1:1 white white white Compatible Risperidone :Titanium dioxide 5:1 white white white Compatible Risperidone :Tri ethyl Citrate 5:1 white white white Compatible Risperidone :Propylene glycol 2:1 white Off white Brown In Compatible Risperidone : Hydroxyl propyl 1:1 white white white Compatible cellulose Risperidone :talc 3:1 white white white Compatible Risperidone :Magnesium 3:1 white Off Off In Compatible Stearate white white Risperidone :Zein 1:1 yellow yellow yellow Compatible Risperidone :Ethyl cellulose 1:5 white Pale yellow Pale yellow In compatible Standard plot of Risperidone: Table 8: Standard plot using 6.8 ph Phosphate Buffer S.No Concentration(µg/ml) Absorbance(nm) Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
8 Absorbance (nm) Standard plot using 6.8 Phosphate Buffer Concentration µg/ml Fig.1: Standard plot using 6.8 Phosphate Buffer y =.382x R² =.9999 Table 9: Standard plot using.1n Hcl S.No Concentration(µg/ml) Absorbance(nm) Absorbance (nm) Standard plot using.1n Hcl Fig.2: Standard plot using.1n Hcl y =.416x R² = Concentration µg/ml Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
9 Preformulation results of Blend: Physical Evaluation (Core tablets): Table 1: Preformulation results of Blend Blend Characterization Formulation B.D (gm/ml) T.D (gm/ml) C.I (%) H.R Result F Poor Flow F Fair F Fair F Fair F Fair F Fair F Good F Good F Good Table 11: Evaluation resardipine Core tablets Physical parameter F1 F2 F3 F4 F5 F6 F7 F8 F9 Weight variation 15± 15± 15± 15± 15± 15± 15± 15± 15± Hardness Thickness (mm) Friability Disintegration time Dissolution Results: Table 12: Dissolution profile for Risperidone tablet (Reference) Reference Product % Cumulative Drug Release Unit/time Unit Unit Unit Unit Unit Unit Average Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
10 Cumulative % Drug Released RESEARCH ARTICLE e-issn: Dissolution Profile of Reference Product Time (min) Refere F1 A Formulation: Fig.3: Dissolution Profile of Reference Product Table 13: Dissolution profile for Risperidone ER tablets % Cumulative Drug Release Unit/time Unit Unit Unit Unit Unit Unit Average F5 A-Formulation: Table 14: Dissolution profile for Risperidone ER tablets % Cumulative Drug Release Unit/time Unit Unit Unit Unit Unit Unit Average Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
11 Cumilative % Drug Released Cumilative % Drug Released RESEARCH ARTICLE e-issn: Dissolution profile of F5 A Reference F5 A Time (Min) Fig.4: Dissolution profile of F5 A formulation F6 A -Formulation: Table 15: Dissolution profile for Risperidone ER tablets % Cumulative Drug Release Unit/time Unit Unit Unit Unit Unit Unit Average Dissolution profile of F6 A Time (Min) Reference F6 A Fig.5: dissolution profile for F6 A formulation Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
12 Cumilative % Drug Released RESEARCH ARTICLE e-issn: F7 A Formulation: Table 16: Dissolution profile for Risperidone ER tablets % Cumulative Drug Release Unit/time Unit Unit Unit Unit Unit Unit Average Dissolution profile of F7 A Reference F7A Time (Min) Fig.6: dissolution profile for F7 A formulation F8 A Formulation: Table 17: Dissolution profile for Risperidone ER tablets % Cumulative Drug Release Unit/time Unit Unit Unit Unit Unit Unit Average Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
13 Cumilative % Drug Released Cumilative % Drug Released RESEARCH ARTICLE e-issn: Dissolution profile of F8 A Time (Min) Reference F8 A Fig.7: dissolution profile for F8 A Comparative Dissolution profile for Risperidone ER tablets with Reference product: Table 18: Comparative Dissolution profile for Risperidone ER tablets with Reference product %Cumulative Drug Release Time Reference F5 A F6 A F7A F8 A Comparative Dissolution Profile of DR Tablets Reference F5 A F6 A F7 A F8 A Time (Min) Fig.8: Comparative Dissolution Profile DISCUSSION The aim of the present study is to develop a pharmaceutically stable, cost effective and quality improved formulation Containing Risperidone as an active moiety. Initially Preformulation studies were Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
14 performed, in this all the parameters such as bulk density, tapped density, Angle of repose, solubility, compatibility Studies is done. In the compatibility study the drug and excipients is mixed and kept at 4 c/75 %Rh for a period of one month. From the results of the compatibility study the excipients were chosen accordingly which are commonly used that are compatible with Active pharmaceutical ingredient. The optimized concentrations of the binder, lubricant, Disintegrant is taken and formulated a tablet. For this tablet the coating is done. Formulations F1A, F2A, F3A is prepared and to those coating is done with 15 % weight buildup in this the tablets compressed with different harness condition and observed the dissolution profile. Formulation F1A the tablets with lower harness showing the dissolution rate faster, and in F3A with higher hard ness it is showing slower release. Formulation F2A containing optimum hard ness showing some similar dissolution profile. From the above data next formulations are compressed at optimum hardness and to those the enteric coating concentration has increased from 15 to 21 % weight build up. The formulation with 21 % buildup of enteric coating is showing similar dissolution profile with reference product. Finally it was concluded that the optimized formula with optimum hardness at 21% weight build up the formula F6A matches with the reference product. Formulations from F1A to F5A the dissolution profile was faster in some cases and slower in some case. Even though all the formulations are releasing the drug but those are not comparable with reference product. Formulation F6A fulfilled all the specifications prescribed for Risperidone Extended release tablets and compared to the reference product. The identified formula shall be utilized for the formulation development and other studies for successful launching of the product. CONCLUSION The approach of present study is to formulate and evaluate Risperidone; Extended Release tablets compared the release profile of our formulation with reference product. Core tablets were prepared with different concentrations of binder, lubricant, Disintegrant and found the physical parameters and from that have optimized the concentration of binder, lubricant, Disintegrant and formulated the core tablet by using wet granulation method due to its poor flow properties. To that core tablet barrier coating was given up to 1.5 % weight build up and then they are enteric coated with initially 15 %. And then by increasing the enteric coating build up for different formulations, finally compared the dissolution with Reference product. REFERENCES 1. Thomas N, Tozer, Malcolm Rowland. Introduction to Pharmacokinetics and Pharmacodynamics, 3 rd ed., 1998; Thomas WYL, Robinson J. The Science and Practice of Pharmacy, 2 th ed., Lippincott, William and Willins, 21; Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
15 3. Leon Lachman, Herbert A, Lieberman, Joseph L, Kanig. The Theory and Practice of Industrial Pharmacy. 3 rd ed., Bombay: Varghese , James W, Mc Ginity, Linda A, Felton. Aqueous polymeric coating for pharmaceutical dosage forms. 3 rd ed., 21; Hogan, Pratha V, Riff D, Ducker S, Schwartz H, Soffer E, Wang W, Rath N., 27. Oral Risperidone in the form of granules or tablets are Pharmaco dynamically equivalent in suppressing acid output in patients with gastro-esophageal reflux disease and a history of erosive oesophagitis. Alimen Pharmacol therapy.1999: 26(2); Horn JR, Howden CW. Similarities and differences among Extended release proton-pump inhibitor formulations. Alimentary Pharmacological Therapy.25:22; Prasanna Reddy, Battu and N Kiran Kumar Reddy. Review on different entric coating polymers. Sesquihydrate in Pharmaceutical dosage forms and Human Plasma.29: 1(2); Kakde RB. Three-wavelength Spectrophotometric Method for Simultaneous Estimation of Risperidone and Domperidone in Pharmaceutical Preparations. International Journal of Pharm Tech Research. 29:1(2); Kinue Nishioka, Taku Nagao and Tetsuro Urushidani. Correlation between Acid Secretion and Proton Pump Activity during Inhibition by the Proton Pump Inhibitors Omeprazole and Risperidone. BiochemicalPharmacology.1999:5(8); Raffin RP, Colome LM, Pohlmann AR, Guterres SS. Preparation characterization and in vivo antiulcer evaluation of Risperidone-loaded micro particles. European Journal of Pharmaceutics and Biopharmaceutics. 26: 6(3); Syed. Formulation and evaluation activity of omeprazole pantoprazole, Risperidone, rabeprazole and esomeprazole.28:3; Urs A, Meyera, Interaction of Proton Pump Inhibitors with Cytochromes P45 Consequences for Drug Interactions. Yale Journal of Biology and Medicine. 1996: 6(9); Horn JR, Howden CW. Similarities and differences among Extended release proton-pump inhibitor formulations. Alimentary Pharmacological Therapy.25: 22; Rajeshwar K. develops gastro resistant drug delivery system for Risperidone. International Journal of Pharmacy and Pharmaceutical Sciences. 21:2(3); Yaswanth D & Anil Kumar K. Int J Trends in Pharm & Life Sci. 215: 1(3);
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