Original Article FORMULATION AND EVALUATION OF TIME-RELEASE COMPRESSION COATED TABLET CONTAINING ACEBROPHYLLINE FOR CHRONOTHERAPY OF ASTHMA * R. B. NAWLE, AKEEL A. TADVEE Department of pharmaceutics, Government college of Pharmacy, Aurangabad (M. S.), India Email: pathanaq77@gmail.com Received: 09 Jul 2014 Revised and Accepted: 20 Aug 2014 ABSTRACT Objective: The aim of present research was to develop compression coated tablet for pulsatile drug delivery of Acebrophylline used for chronotherapy of asthma. The drug delivery system was designed to deliver the drug at such a time when it could be most needful to patient of asthma. Methods: The compression coated tablets containing Acebrophylline in the inner core were formulated by direct compression method with an outer coating of different amounts of HPMC K4M. Results: The release profile of press coated tablet exhibited a lag time depending upon the amount of HPMC K4M in compression coating, followed by burst release. Optimization was done using 3 2 Conclusion: The chronodelivery of Acebrophylline was achieved by formulating the tablet by compression coating technique. factorial design considering two independent factors at three levels. Data was evaluated statistically by Stat Ease Design Expert 7.0.0 software. The optimized batch F6 gave a lag time of 6 hr and drug release of 94% in which the concentration of HPMC K4M is 40% and the concentration of SSG is 2.5 %. Keywords: Compression coated tablet, Lag time, Chronotherapy, Acebrophylline, Asthma. INTRODUCTION In the last several decades has to be seen the development of many controlled-release formulation having the constant drug release rates to maintain the concentration of drug in the human body, apart from the patient’s physiological condition. However, the long-term constant concentration of drug in the human blood and tissue can be the source of problem like tolerability, resistance, and drug side [1]. People are different significantly in their physiological and biochemical condition during any 24 hr period, because of circadian rhythm, and as a result the constant drug delivery into the body seems both needless and unwanted. If the drug release profile mimics a living system's pulsatile hormone secretion, then it may improve drug’s effectiveness, and reduce the toxicity of a specific drug administration schedule. The medication and treatments provided according to the human body's circadian rhythms will result in better outcomes [2]. This can be provided by a chronopharmaceutical dosage regimen with pulsatile release which matches the circadian rhythm resulting from a disease state, so optimizing the therapeutic effect while minimizing side effects [3]. The compression coating technique is a simple and distinctive technology used to provide tablets with a programmable lag phase, followed by a rapid, or rate-controlled, drug release after administration. This technique has many advantages, and there is no special coating solvent or coating equipment is required for manufacturing this type of tablet. Pulsatile drug delivery systems (PDDS) are ahead importance because these systems deliver the drug at particular time as per the pathophysiological need of the disease, resulting in better patient therapeutic efficacy and compliance [4, 5]. Diseases in which PDDS are promising include cardiovascular diseases, asthma, arthritis, hypercholesterolemia, and peptic ulcer. The pathophysiology of arthritis and patients with osteoarthritis tend to have less pain in the morning and more at night; while those with rheumatoid arthritis, have pain that usually peaks in the morning and decreases throughout the day [6, 7]. Compression-coating presents an attractive alternative to spray- coating techniques for high molecular weight polymers. Thick coatings can be applied rapidly and it is a solvent-free coating Process [8]. Compression-coating has been used in the pharmaceutical field for different purposes: (1) To protect hygroscopic, light-sensitive, oxygen-labile or acid- labile drugs [9]. (2) To combine and separate different therapeutic drugs [10, 11]. (3) To modify a drug release pattern (delayed, pulsatile and programmable release of different drugs in one tablet) [12, 13]. Various materials have been investigated as compression coatings to obtain time-controlled release: HPMC [14, 15, 16] hydroxypropyl cellulose [17], polyethylene oxide [18], micronized ethyl cellulose [17], Eudragit RS [18], behenic acid [19]. Bimodal drug release usually obtained with multilayered matrix tablets [20] can also be obtained with compression-coated tablets [21, 22]. The purpose of this study was to develop time-release compression coated tablet containing acebrophylline for chronotherapy of asthma. The oral press coated tablet was developed to achieve the time-controlled disintegrating or rupturing function with a distinct predetermined lag time. The HPMC-compression-coating resulted in release profiles with a distinct lag time depending on the amount of HPMC in compression coating. Burst release was obtained by incorporating a super disintegrant (SSG) within the core tablet. MATERIALS AND METHODS Materials Acebrophylline was obtained as a gift sample from Kores India Ltd. (Mumbai, India.) Sodium Starch Glycolate (SSG), magnesium stearate microcrystalline cellulose (MCC) and Ludipress (directly compressible lactose) were obtained as gift samples from Wockhardt Ltd. (Aurangabad, India.) HPMC K4M was obtained from Colorcon Asia Pvt. Ltd. (Goa) as a gift sample. Methods Fourier Transform Infrared (FTIR) spectroscopy The FTIR spectrum was recorded using Prestige-21 (SHIMADZU) with IR resolution software. The procedure consisted of, placing a drug sample in FTIR cuvette. The drug sample was placed in the light path and scanned over the range of 4000-400 cm -1 on Shimadzu International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 6, Issue 9, 2014 Innovare Academic Sciences