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“FORMULATION AND IN-VITRO CHARACTERIZATION OF FAST DISSOLVING TABLETS OF RANITIDINE HCL” M. Pharm. Dissertation Protocol Submitted to Rajiv Gandhi University of Health Sciences, Bangalore Karnataka By Mr. KONAKONDLA NAGARAJU, B.Pharm. Under the Guidance of Mr. SHRINIVAS GOPAL HUKERI Assistant Professor DEPARTMENT OF PHARMACEUTICS EAST WEST COLLEGE OF PHARMACY BANGALORE – 560 091 2011 – 2013 1 ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1 Name of candidate and address KONAKONDLA NAGARAJU (In Block Letters) MAREMPALLI(VILLAGE), KANEKAL(MANDAL), ANANTAPUR(DIST) ANDHRAPRADESH - 515871. 2 Name of the Institute EAST WEST COLLEGE OF PHARMACY, BANGALORE – 560 091. 3 Course of study and subject: M.PHARM. PHARMACEUTICS. 4 Date of admission of course: 29/10/2011 5 Title of the topic: “FORMULATION AND IN-VITRO CHARACTERIZATION OF FAST DISSOLVING TABLETS OF RANITIDINE HCL” 6 Brief Resume of this intended work: 6.1 Need for the study 6.2 Review of Literature 6.3 Objectives of study Enclosure-I Enclosure-II Enclosure-III 7 Materials and Methods: 7.1 Source of data Enclosure-IV 7.2 Method of collection of data (Including sampling procedure, if any) Enclosure-V 7.3 Does the study require any investigation or interventions to be conducted on patients of humans or animals? If so, please describe briefly. ---------NO---------7.4 Has ethical clearance been obtained from your institution in case of 7.3? -------NOT APPLICABLE------- 8 List of References Enclosure-VI 2 9 Signature of the candidate Mr. KONAKONDLA NAGARAJU 10 Remarks of the Guide 11 Name and designation (in block letters) 11.1 Guide The proposed research work is recommended for registration and approval of Mr. SHRINIVAS GOPAL HUKERI ASSISTANT.PROFESSOR DEPT. OF PHARMACEUTICS EAST WEST COLLEGE OF PHARMACY, BANGALORE - 560091. 11.2 Signature 11.3 Co-Guide (if any) ------------ 11.4 Signature ------------ 11.5 Head of Department Dr. VENKATARAJU. M.P. PROFESSOR AND HOD DEPT. OF PHARMACEUTICS EAST WEST COLLEGE OF PHARMACY BANGALORE-560091 11.6 Signature 12 12.1 Remarks of the Chairman /Principal 12.2 Signature Prof. K. A. SRIDHAR PRINCIPAL EAST WEST COLLEGE OF PHARMACY, BANGALORE.560 091. 3 ENCLOSURE-I 6) Brief resume of the intended work: 6.1) Need for the study: Oral dosage forms are popular, but for some it is difficult to swallow, for these reasons formulation is modified into fast dissolving tablets as a novel drug delivery system. Fast dissolving tablets are those when placed on the tongue disintegrates instantaneously releasing the drug which dissolve or disperse within 15 sec to 3 minutes. Addition of superdisintegrants is one of the popular techniques for the formulation of fast dissolving tablets where by optimum concentration of superdisintegrants is added to the formulation to achieve rapid disintegration1. Peptic ulcer arises in the part of GIT which is exposed to gastric acid and pepsin. It is due to imbalance between the aggressive factor (gastric acid, pepsin, helicobacter pylori) and the defensive factor (gastric mucus, bicarbonate secretion, prostaglandins, nitric oxide and innate resistance of the mucosal cells). In duodenal ulcer, acid secretion is high. Ulceration is due to high concentration of gastric acid pepsin or due to infection of helicobacter pylori2. Ranitidine hydrochloride comes under furans. It is a non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2receptors).The Chemical name is: dimethyl [(5-{[(2-{[(E)-1-(methyl amino)-2-nitroethenyl] amino} ethyl) sulfanyl] methyl} furan-2-yl) methyl] amine HCL. Empirical formula is C13H22N4O3S∙HCL. Average molecular weight is 314.404. Absorption of Ranitidine HCL is moderate it undergoes hepatic metabolism and an H2 receptor antagonist, H2 antagonists are competitive inhibitors of histamine at the parietal cell H2 receptor. They suppress the normal secretion of acid by parietal cells and the meal-stimulated secretion of acid. They accomplish this by two mechanisms: histamine released by ECL cells in the stomach is 4 blocked from binding on parietal cell H2 receptors which stimulate acid secretion, and other substances that promote acid secretion (such as gastrin and acetylcholine) have a reduced effect on parietal cells when the H2 receptors are blocked. It is mainly used for the treatment of peptic ulcer3. The present aim is an attempt to formulate Ranitidine hydrochloride fast dissolving tablet to increasing its disintegration rate, by using various techniques such as, direct compression/wet granulation/ dry granulation/ intra and extra granulation technique or any suitable method with suitable drug carriers. To evaluate the in-vitro drug release studies. 5 ENCLOSURE-II 6.2) Review of literature: Chandira RM et al., have prepared fast dissolving tablets of Ondosetron hydrochloride by direct compression method using different super disintegrates. All the formulations were evaluated for disintegration time, wetting time, weight variation, percentage friability and In-vitro dissolution rate. Formulations with 2% indion 414 and drug: Indion 204 in 1:2 ratio and with 2% indion 414 and drug: Eudragit E100 in 1:4 ratios showed the disintegration time 10 seconds, 15 seconds and wetting time 30 seconds and 33 seconds respectively. In-vitro dissolution studies of both formulations showed more than 90% drug released within 15 minutes. In-vitro release profile, disintegration time and wetting time remained unchanged after two months when stored at250C /60% RH and at400C/75%RH4. Prajapati BG et al., have investigated directly compressed orally disintegrating tablets of Piroxicam for mechanical integrity, content uniformity and characterized different super disintegrants were used in the formulation such as Crospovidone, Croscarmellose sodium, Sodium starch glycolate’s by in-vitro disintegration time and in-vitro drug release. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, disintegration time, wetting time and in-vitro drug release. The orally disintegrating tablets of Piroxicam consisting of 7% Crospovidone showed the minimum disintegration time, in comparison with other formulation, DSC studies indicated compatibility between drug and excipients5. Arya A et al., have prepared mouth dissolving tablets of Ranitidine hydrochloride using sublimation method Ammonium bi carbonate as a sublimating agent. The tablets were evaluated other formulation of mouth dissolving tablets of Ranitidine hydrochloride were prepared by using Sodium starch glycolate and Croscarmellose sodium as super 6 disintegrants. Tablets formulated by using Croscarmillose sodium as super disintegrant showed better disintegrating property and drug release profile in comparison with other formulated tablets prepared by sublimation method6. Ahad HA et al., have made an attempt to develop mouth dissolving tablets of Ondosetron hydrochloride by including Clove oil. The tablets were prepared by direct compression technique, the formulated tablets were evaluated for preformulation, post formulation parameters and result were found to be satisfactory. Formulated tablets with Croscarmellose sodium as super disintegrant showed better drug release property and drug content7. Yadav IK et al., have formulated an uncoated micro pellet of Nimesulide to improve its bio availability and micromeritic property and developed fast dissolving tablets, the formulated Nimesulide micro pellets were used for development of fast dissolving tablets. They evaluated for general characteristics and in-vitro dissolution. The disintegration time and dissolution profile of fast dissolving tablets of Nimesulide micro pellets were compared with the fast dissolving tablets containing plain Nimesulide and formed that fast dissolving tablets prepared with Nimesulide micro pellets are fast disintegrating and have improved dissolution profile then fast dissolving tablets prepared with plain Nimesulide8. Kakade SM et al., have designed Losartain potassium mouth dissolving tablets to enhance the patient compliance and to provide a quick onset of action, mouth dissolving tablets of Losartain potassium were formulated by direct compression method using super disintegrant such as Poly Plasdone XL10 Croscarmellose sodium Explotab in different concentration and evaluated for the pre compression parameters. The formulated tablets were evaluated for post compression parameters and In-vitro dissolution profile. Evaluated results showed that formulated tablets contain 5% w/w Plosidone XL10 released 99.26% in12 minutes9. 7 Kawtikwar PS et al., have prepared bitter less fast dissolving tablets of Tizanidine hydrochloride using Eudragit E100 as taste masking agent. Mass extrusion was the technique used for prepared taste masked granules .the tablet was prepared with three super disintegrants e.g. Sodium starch glycolate, Croscarmellose sodium and Crospovidone. The blend was examined for pre compression parameters. The tablets were evaluated for post compression parameters, the Disintegration time was 22 seconds. Tablets prepared by using Sublimation method by using Camphor as sublimating agent. It showed that tablets are prepared by addition of super disintegrant has less disintegration time then those prepared by Sublimation method10. Mehta M et al., have investigated the development of fast dissolving tablets of Sertraline HCl. Different formulations were formulated by incorporating a combination of superdisintegrants (physical mixtures and co-processed mixtures) Sodium starch glycolate and Crospovidone by direct compression method. The formulations were evaluated for various physicochemical parameters, disintegration time and in-vitro drug release. The formulation had disintegration time less than 3 and released maximum amount of drug by 5 minutes. Co-processed mixtures had less disintegration time as compared to the physical mixtures11. 8 ENCLOSURE-III 6.3) Objective of the study: The present study is planned with the following objectives: To bring out the fast dissolving tablets of Ranitidine hydrochloride. Preparation and optimization of fast dissolving tablet containing Ranitidine hydrochloride by, direct compression/ Wet granulation /Dry granulation /Intra and Extra granulation technique by using different adjuvant’s and excepients. To find out the compatibility between the drug and excepients. To evaluate the pre compressional granular properties. To investigate the post compressional parameters of prepared formulations. To carry out in-vitro drug release studies for prepared formulation. 9 ENCLOSURE- IV 7) Materials and Methods: Materials: Drug: Ranitidine hydrochloride. Excepients: Micro crystalline cellulose, super disintegrants such as Croscarmellose Sodium, crospovidone, sodium starch glycolate or any other suitable disintegrants will be Selected alone or in combination for the development of fast dissolving tablets of Ranitidine hydrochloride. Sweetening agent: Mannitol/Aspartame/sodium saccharin, or any other suitable drug Carrier and excepients used to formulate FDT’s of Ranitidine hydrochloride. And suitable polymer and excepients will be used in the formulation of FDT’s. Methods: Preparation of fast dissolving tablets containing Ranitidine hydrochloride with different super disintegrates will be prepared by wet granulation/ dry granulation/ direct compression/ Intra and Extra granulation or any other suitable appropriate methods. 7.1) Source of data: Data is collected from: RGUHS library. Internet. Research and review publication. International and Indian journals. Textbooks and reference books. Drug bank. 10 ENCLOSURE-V 7.2) Method of collection of data: Standardization, selection, process development and preparation of fast dissolving tablets containing Ranitidine hydrochloride. Evaluation of pre compression and post compression parameters for prepared formulations Pre compression parameters: Angle of repose Bulk density Tapped density Carr’s index Compressibility index Post compression parameters: Weight variation Hardness Thickness Friability Water absorption ratio. Wetting time. In-vitro disintegration time. In-vitro dissolution time. Estimation of drug content in the developed formulations. Investigation of in-vitro drug release profile for developed formulations. To carry out statistical analysis of in-vitro drug release for optimized formulated tablets. 11 ENCLOSURE- VI 8) List of references: 1. Bhowmik D, Chiranjib .B, Krishnakanth, Pankaj, Chandira R.M. Fast Dissolving Tablet: An Overview. J Chem Pharm Res 2009:1(1):163-77. 2. Tripathi KD. Essentials of Medical Pharmacology 5thed. New Delhi (IND) Jaypee Brother Medical Publication.2003:587-91. 3. www.drugbank.ca 4. Chandira RM, Bhowmik D, Venkaeteswarlu BS, Khumudhavalli MV and Dr. Jayakar B. Formulation and evaluation of taste masked fast dissolving tablets of Ondosetron hydrochloride. J pharm Res 2008:1(2):200-07. 5. Prajapati BG, Patel B. Formulation, evaluation and optimization of orally disintegrating tablets of Piroxicam. Int J Pharm Tech Res 2010:3(2):1893-99. 6. Arya A, Sharma S, Jitendra Kumar, Chandra A, Jaiswal P. Formulation and evaluation of mouth dissolving tablets of Ranitidine hydrochloride Int J Pharm Tech Res 2010:2(2):1574-77. 7. Ahad HA, Anuradha CM, Suresh Kumar C, Reddy KKB and Jagadish Kumar D. Novel approach in formulation and evaluation of mouth dissolving tablets of Ondosetron hydrochloride. Int J App Bio Pharm Tech 2010:2(1):582-88. 8. Yadav IK, Jaiswal D, Singh HP, Chandra D and Jain DA. Formulation evaluation and optimization of fast dissolving tablets containing Nimesulide micro pellets. Int J Chem Tech Res 2009:1(4):910-14. 9. Kakade SM, Mannur VS, Ramani KB, Dhada AA, Navel CV and Bhagwat A. Formulation and evaluation of mouth dissolving tablets of Losartan potassium by direct compression technique. Int J Res Pharm Sci 2010:1(3):290-95. 12 10. Kawtikwar PS, Zade PS and Sakarkar DM. Formulation, evaluation and optimization of fast dissolving tablets containing Tizanidine hydrochloride. Int J Pharm Tech Res 2009:1(1):34-42. 11. Mehta M, Bhagwat DP, Gupta GD. Fast dissolving tablets of Sertraline hydrochloride. Int J Chem Tech Res 2009:1(4):925-30. 13