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DESIGN and IN-VITRO EVALUATION of FAST DISINTEGRATING TABLETS of FLUPIRTINE Sridhar Rao

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DESIGN and IN-VITRO EVALUATION of FAST DISINTEGRATING TABLETS of FLUPIRTINE Sridhar Rao Sridhar Rao. K*et al. /International Journal of Pharmacy & Technology ISSN: 0975-766X CODEN: IJPTFI Available Online through Research Article www.ijptonline.com DESIGN AND IN-VITRO EVALUATION OF FAST DISINTEGRATING TABLETS OF FLUPIRTINE Sridhar Rao. K*1, Sreekanth. J2 1Department of Pharmaceutics, Trinity College of Pharmaceutical Sciences, Peddapalli, Karimnagar, Telangana- 505172. 2Director of Research and Development, Progenerics Pharma Pvt. Ltd., Sanathnagar, Hyderabad, Telangana-500018. Email id: [email protected] Received on: 05-03-2017 Accepted on: 08-04-2017 Abstract Aim: The main objective of this study was to formulate and evaluate fast disintegrating tablets of Flupirtine (FFDT’s) prepared by direct compression method using super-disintegrants as well as subliming agents with a view to enhance patient compliance. Materials: Flupiritine (Perkin pharmaceutical Pvt Ltd, Mumbai), Low-substituted hydroxypropyl cellulose (L-HPC-12), Locust Bean Gum used as super disintegrates, Camphor and Menthol used as subliming agents, Microcrystalline cellulose (PH- 102) and Sodium xylitol as diluents (DR.Reddy’s Laboratories Hyderabad), Sod. Saccharine and Rasberry Flavor as sweeting agent (SD Fine Chemicals Pvt Ltd, Mumbai), Colloidal silicon di oxide (Aurobindo Pharmaceuticals, Hyderabad) and Magnesium stearate (Qualikems Fine Chem Pvt. Ltd, Vadodara) as lubricating agents. All the above following materials were either AR/LR grade were used in the above work and which were supplied from the manufacturer. Results: Flupirtine is the prototype of a new class of drug and it is selective neuronal potassium channel opener (SNEPCO) which is used as an analgesic for acute and chronic pain, in moderate to severe cases. The main objective of this study was to formulate and evaluate fast disintegrating tablets of Flupirtine (FFDT’s) prepared by direct compression method using super-disintegrants as well as subliming agents with a view to enhance patient compliance. Two different super- disintegrants, such as L-HPC and Locust Bean gum were selected in different ratio (2 and 4 % w/w) and in order to IJPT| April-2017| Vol. 9 | Issue No.1 | 29307-29319 Page 29307 Sridhar Rao. K*et al. /International Journal of Pharmacy & Technology ensure the disintegrating effect by choosing the different concentrations of subliming agents such as camphor and menthol with alone, as well as combination. FTIR study reveals that there was no drug-excipients interaction between Flupirtine and used excipients. There after all pre & post compressional studies were evaluated including In-vitro dissolution studies. It was observed that the formulation F10 with 4% of L-HPC having an equal concentration (5% w/w each) of camphor and menthol showed satisfactory results with disintegration time of 30±1.04 seconds, wetting time of 25±1.91 seconds, water absorption ratio 58±1.07 seconds and with highest dissolution rate of 94.68±0.62% in 30 min. From the above results, it was concluded that a combined equal portions of camphor and menthol has shown faster disintegration and dissolution effect on formulation (F10) having super disintegrant of L-HPC with 4% (w/w) concentration. Conclusion: The main objective of present work was to design and In-vitro evaluation of FFDT’s by selecting the super disintegrates such as L-HPC and Locust bean gum along with both subliming agents such as camphor and menthol. By choosing these components F1-12 formulations were fabricated with changing their concentration as alone and combination of both. Then all the pre & post compressional parameters were carried out including In-vitro dissolution studies to determine the fastest drug release from the dosage forms. Based on these results, F10 formulation was released 94.68±0.62 percentage within 30 minutes compared to all the above formulations so it was confirmed as an optimized formulation. Key words: Flupirtine, L-HPC-12, Locust Bean Gum, Sod. Xylitol, MCC (PH102), Camphor and Menthol. Introduction: Most of pharmaceutical solid dosage forms are fabricated for direct ingestion, chewing, prior dispersion and/or dissolution in water; few of dosage forms are absorbed in the mouth. In past decades patients have difficulty in swallowing when prescribed in conventional tablet and capsule forms [1-3]. The problem of swallowing is also evident in pediatrics, psychiatric as well as traveling patients who may not have ready access to water [4]. The rapidly disintegrating tablet in the mouth or orodispersible tablets overcome all the above problems and thus offer an alternate form of oral medication, which provide patients with a more convenient means of administration of their medication [5]. Addition of super disintegrating agent in the formulation is one of the approaches to formulate oro dispersible tablets [6- 7]. Orally disintegrating tablets (ODTs) rapidly disintegrate in the mouth without chewing on oral administration and IJPT| April-2017| Vol. 9 | Issue No.1 | 29307-29319 Page 29308 Sridhar Rao. K*et al. /International Journal of Pharmacy & Technology without the need for water, unlike other drug delivery systems, and conventional oral solid immediate-release dosage form. ODT dosage forms, also commonly known as fast melt, quick melts, fast disintegrating and orodispersible systems have the unique property of disintegrating the tablet in the mouth in seconds. The desired criteria for the FDT is to have a pleasant mouth feel, leave minimal or no residue in the mouth after oral administration and not require water to swallow, but it should dissolve or disintegrate in the mouth in a matter of seconds [8, 9]. Most commonly used methods to prepare these tablets are; freeze-drying / Lyophilization [10], tablet molding [11] and direct compression methods [12]. Lyophilized tablets show a very porous structure, which causes quick penetration of saliva into the pores when placed in the oral cavity. Molded tablets dissolve completely and rapidly. However, lack of strength and taste masking are of great concern. Main advantages of direct compression are low manufacturing cost and high mechanical integrity of the tablets [13]. Therefore, direct compression appears to be a better option for manufacturing of tablets. The key to the rapid disintegration of fast dissolving tablets (FDT) is the preparation of a porous structure in the tablet matrix. To generate such a porous matrix, volatile ingredients are incorporated in the formulation that is later subjected to a process of sublimation. Highly volatile ingredients such as camphor, menthol, and urea may be compressed along with other excipients into a tablet. This volatile material is then removed by sublimation leaving behind a highly porous matrix. In present research work, an attempt has been made to prepare FDT of Flupirtine by using direct compression technique. Flupirtine is a novel, centrally acting, non-opioid and non NSAID analgesic agent, and is devoid of common adverse effects seen with NSAIDs and opioids. Chemically it was an aminopyridine whose systematic (IUPAC) name is ethyl {2-amino-6-[(4-fluorobenzyl) amino] pyridin-3-yl} carbamate. Its Formula is C15H17FN4O2 and molecular mass of 304.32 g/mol. In addition to analgesic action, it has also muscle relaxant, antioxidant, neuroprotective and antiparkinsonian effects. Methodology: Estimation of Flupirtine by spectrophotometric method: Take and dissolve required quantity of Flupirtine in equal volume of solution (pH 6.8 buffer). From which, subsequent dilutions were prepared to get 2, 4, 6, 8, 10 & 12 mcg/ml concentrations of Flupirtine solution. Thereafter the absorbance was recorded by using UV-visible spectrophotometer at 246 nm. IJPT| April-2017| Vol. 9 | Issue No.1 | 29307-29319 Page 29309 Sridhar Rao. K*et al. /International Journal of Pharmacy & Technology Drug - Excipient compatibility: These studies were performed by preparing powder blend containing different ratios of excipients with drug by FTIR spectrometer, which is most powerful technique to identify functional groups of the drug in order to ensure suitable chemically compatible excipients. Hence in this present study potassium bromide disc (pellet) method was employed for recording the spectra from 4000 - 400cm-1. Evaluation of powder blend: Organoleptic properties: A small amount of Flupirtine powder was taken on a butter paper and viewed in illuminated place to observe the color, as well as smelled to get odor and tasted with the help of tongue. Shown in table: 01 Table-01: Results of organoleptic properties. Properties Results Description crystalline powder Colour White in color Taste and odor Bitter and odorless Bulk density (Db): Take required quantity of powder and carefully poured in to a graduated cylinder, which was previously passed through sieve # 40. Then pour the powder and note down the bulk volume which was produced from the cylinder and the bulk density is calculated by following formula; Bulk density = Weight of powder / Bulk volume Tapped density (Dt): Tapped volume was noted by tapping the powder for 100 tappings for each time. If two volumes difference was more than 2%, tapping was continued until the successive volumes are less than 2 % in a bulk density apparatus. It was calculated by the following formula; Tapped density = Weight of powder / Tapped volume. Angle of repose: It is maximum possible angle between the horizontal plane and powder surface. These resistance forces of free powder can be measured by the angle of repose (θ). It was determined by a formula: tan (θ) = h / r Hausner’s ratio: Hausner’s ratio is an indirect index of ease of powder flow. It is calculated by following formula; Hausner’s ratio = Tapped density / Bulk density. Compressibility index: The compressibility index (Carr’s Index) was determined by using following equation; Carr’s Index (%) = [(Dt – Db) × 100] / Dt. where Dt: Tapped density of powder, Db: Bulk density of powder. IJPT| April-2017| Vol. 9 | Issue No.1 | 29307-29319 Page 29310 Sridhar Rao. K*et al. /International Journal of Pharmacy & Technology Formulation of Flupirtine Fast disintegrating Tablets (FFDT’s) Direct compression method: It is one of the most convenient methods to fabricate Flupirtine Fast Disintegrating Tablets.
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