Journal of PharmaSciTech Formulation and in vitro Evaluation of Frovatriptan Succinate Oral Disintegrating Tablets by Direct Compression Technique 1 2 1 1 1 1 Ashok Thulluru *, G Srikanth , S Firoz , V C Ekanth Chowdary , K Aruna , K Geetha The most preferred route for administration of dosage forms is oral route, due to its potential advantages like ease of administration, convenient dosing, self-medication, no pain and patient compliance. Hence tablets and capsules are the most popular dosage forms [1]. But important drawback of these dosage forms is dysphasia [2]. The above-mentioned problem can be solved by developing a fast disintegrating/dissolving drug delivery, i.e. oral disintegrating / dissolving tablet, disintegrates and dissolves rapidly in the saliva, within a few sec without the need of drinking water or chewing [3]. In pharmaceutical sciences, disintegration usually means the process by which a solid dosage form breaks up when it comes in contact with aqueous medium absorption and thus promotes rapid release of drug for faster absorption [4]. A rapid disintegration process is the prerequisite for a good bioavailability [5]. Orally disintegrating tablets (ODT) provides ease of administration, immediate action, convenient dosing, self-medication, no pain and increases patient compliance [6]. Frovatriptan succinate (FS), a selective 5-hydroxytryptamine 1B/1D (5-HT ) receptor subtype agonist. FS is indicated for the acute 1B/1D treatment of migraine attacks with or without aura in adults. FS is incompletely absorbed in the GI tract and undergoes extensive hepatic metabolisin due to cytochrome P450 1A2. The absolute bioavailability of an oral dose of frovatriptan 2.5 mg in healthy subjects is about 20% in males and 30% in female [7]. Clinically, orotransmucosal drug delivery is reported to be the most promising alternative approach for enhancing the bioavailability and fastening the onset of action in comparison to its conventional tablets because it has high blood supply, a very thin membranous barrier (190 m), and an ability to bypass hepatic first pass metabolism [8]. Therefore, ODT could be a promising dosage form for the administration of FS for treating acute migraine attack. Materials and methods Materials Frovatriptan Succinate (FS) is a gift sample received from Natco µ Pharma Ltd, Hyderabad, India. Sodium Starch Glycolate, croscarmellose sodium (Ac-Di-Sol), crospovidone (Polyplasdone XL-10), dicalcium phosphate, aspartame, magnesium Stearate, talc and colloidal silicon dioxide (AEROSIL) are received as gift samples from Glochem pharma Ltd, Hyderabad India. All the excipients used in study are of pharmaceutical grade. Methods Standard calibration curve of FS in pH 6.8 phosphate buffer [9] It was obtained at the λmax 291 nm using a UV-Visible spectrophotometer (UV-1700, Shimadzu, Mumbai, India) and represented in Figure 1, which was further used for drug release calculations of in vitro dissolution studies and assay. Abstract Keywords: Frovatriptan Succinate (FS), Orally disintegrating tablets (ODT), Sodium Starch Glycolate (SSG), croscarmellose sodium (CCS), crospovidone (CPV), direct compression, In vitro dissolution study The aim of present study was to formulate Frovatriptan Succinate (FS) as Orally disintegrating tablets (ODT) using various concentrations of super disintegrents like, Sodium Starch Glycolate (SSG), croscarmellose sodium (CCS), crospovidone (CPV) by direct compression. To enhance its bioavailability and to fasten its onset of action in comparison to its conventional tablets. Standard calibration curve of FS was obtained in pH 6.8 phosphate buffer by spetrophotometric method, drug-excipient compatibility studies were carried by isothermal stress studies and confirmed by FT-IR studies. All the Formulations were evaluated for pre-compression, post-compression studies. Accelerated stability studies up to 6 months were conducted for the optimized formulation (F9). The drug-excipient compatibility studies reveals that all the excipients used are compatible with FS. Pre & post compression parameters were within the acceptable limits for all formulations. An in vitro dissolution kinetic study indicates the release rate of FS from ODT increases as the concentration of super disintegrents increases. Among all super disintegrents formulations with CPV are having faster release profiles and the order of super disintegrants to enhance dissolution rate in the formulations of FS ODT is CPV > CCS > SSG. Formulation F9 (8% w/w CPV) released 100 % of drug with in 6 min was considered as the optimal ODT among all the nine formulations tested in this study. Optimized formulation (F9) passed the test for stability in its in final pack. Hence, an effective FS ODT dosage form for treating acute migraine attack was formulated by direct compression technique. ISSN: 2231 3788 (Print) 2321 4376 (Online) Research Article 1 Department of Pharmaceutics, Sree Vidyanikethan College of Pharmacy, Tirupati-517102,Chittoor Dist. Andhra Pradesh St., India 2 Hospira Health Care India Pvt. Ltd; Chennai-600001, Tamil Nadu St., India Introduction Volume 6, Issue 2, 2016; Journal of PharmaSciTech http://www.pharmascitech.in Figure 1: Standard calibration curve of FS in pH 6.8 phosphate buffer Drug-excipient compatibility / isothermal stress studies [10] These were performed in order to evaluate the integrity and compatibility of the drug with various excipients used in the formulation. The physical mixtures of drug and excipients (1:1 ratio), were sealed in 4 mL glass vial using a teflon-lined screw cap and 82 *Correspondence: ashokthulluru@gmail.com (Tel. +91-7729995793)