FORMULATION AND EVALUATION OF RANITIDINE HYDROCHLORIDE FLOATING TABLET

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FORMULATION AND EVALUATION OF RANITIDINE HYDROCHLORIDE FLOATING TABLETS:

FORMULATION AND EVALUATION OF RANITIDINE HYDROCHLORIDE FLOATING TABLETS PRESENTED BY kollamprasad M.Pharm 2 nd yr 08M71S0302 UNDER THE GUIDANCE OF : OUR BELOVED PRINCIPAL: A.V.BADARINATH Dr. C. Madhusudhana Chetty M . Pharm ( Ph.D ) M . Pharm , Ph.D , M.B.A. DEPARTMENT OF PHARMACEUTICS ANNAMACHARYA COLLEGE OF PHARMACY

AIM :

AIM To Formulate and evaluate the Floating tablets of Ranitidine Hydrochloride by using different polymers such as; HPMC K-100,HPMC K-15,SCMC, Gelatin, Sodium alginate and Xanthan gum. Improve the bioavailability of the drug. To avoid the colonic degradation of Ranitidine . To increase the efficiency of the drug. Reduction of dosing frequency. Providing sustained action. To improve patient compliance.

PROTOCOL:

PROTOCOL Granulation Preformulation (flow properties) Physico chemical evaluations Invitro Studies Stability studies Analytical studies Wet granulation Angle of repose Bulk density Tapped density Porosity Carr’s Index Hausner’s index Hardness Thickness Diameter Friability Drug content Weight variation Floating lag time Invitro Buoyancy Invitro Drug Release UV Spectrophot-ometry HPLC DSC FDIR

RANITIDINE HYDROCHLORIDE:

RANITIDINE HYDROCHLORIDE Structure: Formula: C 13 H 22 N 4 O 3 S Molecular weight: 314.4040 Drug Category: Anti-Ulcer Agents Histamine H2 Antagonists Description: It is available as an characteristic odour, bitter taste, pale yellow granular powder. It is freely soluble in 0.1NHCL,water, methanol, ethanol(95%) very slightly soluble in chloroform, dichloromethane. Half-life is 3-4 hrs. Dose: 150mg,four times a day Uses: Ranitidine used in the treatment of dyspepsia, Peptic ulcer disease, Duodenal ulcer, Gastric ulcer, Gastritis, Zollinger-Ellison Syndrome, Stress ulcer, and reflux esophagitis.

HPMC :

HPMC Structure: Synonyms: Hydroxypropyl methylcellulose; Methocel. Applications Coating agent; film-former; rate-controlling polymer for sustained release; stabilizing agent; suspending agent; tablet Binder; viscosity-increasing agent. Description: Hypromellose is an odorless and tasteless, white or creamy white fibrous or granular powder. Solubility: Soluble in cold water, practically insoluble in chloroform, ethanol (95%), and ether, but soluble in mixtures of ethanol and dichloromethane, mixtures of methanol and dichloromethane. Viscosity: A wide range of viscosity types are commercially available.

SCMC:

SCMC Structure: Synonyms Cellulose gum; CMC sodium;SCMC; sodium CMC. Description: Carboxy methyl cellulose sodium occurs as a white to almost white, odorless, granular powder. Applications Coating agent; stabilizing agent; suspending agent; tablet binder; viscosity-increasing agent. Solubility: Practically insoluble in acetone, ethanol (95%), ether, and toluene. Easily dispersed in water at all temperatures, forming clear, colloidal solutions. Viscosity: 5–13 000 mPa s may be obtained. An increase in concentration results in an increase in aqueous solution viscosity.

GELATIN:

GELATIN Synonyms: Byco; Cryogel; gelatine; Instagel; Solugel. Description: Gelatin occurs as a light-amber to faintly yellow-colored. It is practically odorless and tasteless and is available as translucent sheets and granules, or as a powder. Applications: Coating agent; film-former; gelling agent; suspending agent; tablet binder; viscosity-increasing agent. Solubility: practically insoluble in acetone, chloroform, ethanol (95%), ether, and methanol. Soluble in glycerin, acids, and alkalis, although strong acids or alkalis cause precipitation. Viscosity: 4.3–4.7 mPa s (4.3–4.7 cP) for a 6.67% w/v aqueous solution at 60C; 18.5–20.5 mPa s (18.5–20.5 cP) for a 12.5% w/v aqueous solution at 60C .

SODIUM ALGINATE:

SODIUM ALGINATE Synonyms: Algin; alginic acid, sodium salt; Keltone. Description: Sodium alginate occurs as an odorless and tasteless, white to pale yellowish-brown colored powder. Applications : Stabilizing agent; suspending agent; tablet binder; viscosity-increasing agent. Solubility: Practically insoluble in other organic solvents and aqueous acidic solutions in which the pH is less than 3. Slowly soluble in water, forming a viscous colloidal solution. Viscosity: 20–400 mPa s (20–400 cP). Viscosity may vary depending upon concentration, pH, temperature, or the presence of metal ions. Above pH10, viscosity decreases.

XANTHAN GUM:

XANTHAN GUM Synonyms: Corn sugar gum; E415; Keltrol; xantural. Description: Xanthan gum occurs as a cream- or white-colored, odorless, free-flowing, fine powder. Applications: Stabilizing agent; suspending agent; viscosity-increasing agent. Solubility: Practically insoluble in ethanol and ether; soluble in cold or warm water. Viscosity: 1200–1600 mPa s (1200–1600 cP) for a 1% w/v aqueous solution at 258C.

FORMULATION:

FORMULATION S.no INGREDIENTS F-1 (mg) F-2 (mg) F-3 (mg) F-4 (mg) F-5 (mg) F-6 (mg) F-7 (mg) F-8 (mg) F-9 (mg) F-10 (mg) F-11 (mg) F-12 (mg) 1. 2. a b c d e f 3. 4. 5. 6. 7. 8. Drug Polymers HPMC-K100 HPMC-K15 SCMC Gelatin Sodium Alginate Xanthin Gum NaHCO 3 Lactose Stearic acid Citric acid Mag .Stearate Talc 156 150 - - - - - 50 46 15 15 9 9 156 - 150 - - - - 50 46 15 15 9 9 156 - - 150 - - - 50 46 15 15 9 9 156 - - - 150 - - 50 46 15 15 9 9 156 - - - - 150 - 50 46 15 15 9 9 156 - - - - - 150 50 46 15 15 9 9 156 75 75 - - - - 50 46 15 15 9 9 156 75 - 75 - - - 50 46 15 15 9 9 156 - 75 75 - - - 50 46 15 15 9 9 156 - - - 75 75 - 50 46 15 15 9 9 156 - - - 75 - 75 50 46 15 15 9 9 156 - - - - 75 75 50 46 15 15 9 9

STANDARD GRAPH OF RANITIDINE HCL:

STANDARD GRAPH OF RANITIDINE HCL

PREFORMULATION:

PREFORMULATION Flow properties: The tablet blend were evaluated for their bulk density, tapped density, angle of repose, compressibility index, porosity and hausner’s index. The bulk density of the powder formulation was in the range of 0.33-0.37 gm/cc; the tapped density was in the range of 0.37-0.45 gm/cc. The angle of repose of the drug powder was in the range of 23-30, which indicate excellent flow of the powder, porosity was found to be in the range of 11.1-18.5, the Carr’s index was found to be in the range of 10-22, hausner’s index was found to be in the range of 1.12-1.24 indicating compressibility of the tablet blend is fairly passable.

PHYSICO CHEMICAL EVALUATIONS:

PHYSICO CHEMICAL EVALUATIONS Hardness: The Monsanto hardness tester was used to determine the tablet hardness. The prepared tablets in all formulations possessed good mechanical strength with sufficient hard ness the range is 4.5-5.5 kg Thickness and diameter: The thickness and diameter of the tablet was measured in mm using Vernier Calipers. The thick ness of the tablets were found to be in the range of 4±0.2. The diameter of the tablets were found to be in the range of 12mm Friability: Tablet strength was tested by Roche friabilator. The Friability of the tablets were found to be in the range of 0.66-0.78 Drug content: Randomly selected 10 tablets were weighed and triturated. 100mg equivalent weight is dissolved in 100ml 0.1N HCl buffer.aliqouts are observed by U.V spectrophotometer (labmed). The prepared formulations range is 85- 92 Weight variation: Randomly selected 20 tablets were weighed individually and together. The average weight was noted and standard deviation was calculated. The prepared formulations range is 450±10 Floating lag time: The test was performed using USP type II paddle type apparatus (Electrolabs) using 900 ml of 0.1 N HCl at paddle rotation of 50 rpm at 37±0.50. Among all the formulations, F1 and F3 formulations showed good floating properties with floating lag time of 110 sec and 120 sec respectively.

INVITRO STUDIES :

INVITRO STUDIES Invitro Buoyancy: The duration of time the dosage form constantly remained on the surface of medium was determined as the total floating time (TFT). The formulations shows a TFT of 14-15 h, and flotation was achieved maximum. Invitro Drug Release: In vitro drug release of the formulation was carried out by USP type II basket type apparatus with rotating speed of 50 rpm and at temperature of 37±0.50 C. The dissolution medium used was 0.1N HCl (pH 1.2). The samples were withdrawn at predetermined time intervals and suitably diluted and were analyzed using UV/Visible spectrophotometer (lab med) .Among all the formulations, F1 and F3 formulations showed greater retardation of drug release.

FUTURE STEPS:

FUTURE STEPS Stability studies Analytical methods DSC FTIR

CONCLUSION:

CONCLUSION

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