Aim:The current paper was an attempt to design a sustained release dosage form using various grades of hydrophilic polymers, Hypromellose (hydroxyl-propyl methylcellulose [HPMC] K15M, HPMC K100M and HPMC K200M) and Polyacrylate polymers, Eudragit RL100 and Eudragit RS100 with or without incorporating ethyl cellulose on a matrix-controlled drug delivery system of Metformin hydrochloride.Materials and Methods:Laboratory scale batches of nine tablet formulations were prepared by wet granulation technique (Low shear). Micromeritic properties of the granules were evaluated prior to compression. Tablets were characterized as crushing strength, friability, weight variation, thickness, drug content or assay and evaluated for in-vitro release pattern for 12 h using Phosphate buffer of pH 6.8 at 37 ± 0.5°C. The in-vitro release mechanism was evaluated by kinetic modeling.Results and Discussion:The results obtained revealed that HPMC K200M at a concentration of 26% in formulation (F6) was able to sustain the drug release for 12 h and followed the Higuchi pattern quasi-Fickian diffusion. With that, combined effect of HPMC K15M as an extragranular section and Eudragit RS100 displayed a significant role in drug release. Dissolution data were compared with innovator for similarity factor (f2), and exhibited an acceptable value of ≥50 Three production validation scale batches were designed based on lab scale best batch and charged for stability testing, parameters were within the limit of acceptance. There was no chemical interaction found between the drug and excipients during Fourier Transform Infrared Spectroscopy (FTIR) and Differential scanning calorimetry study.Conclusion:Hence, combinely HPMC K200M and Eudragit RS100 at a suitable concentration can effectively be used to sustain drug release.
Objective: In the current work, an attempt was made to formulate the chrono pharmaceutical drug delivery of Ivabradine HCl to the colon. A time-delayed capsule was prepared by sealing the micro particles inside a gelatin capsule made up of erodible hydrogel plug. Methods: The microparticles were formulated by counter-ion elicited aggregation methodology. A natural polymer such as chitosan was chosen as polycation and smaller molecular electrolytes like sodium citrate, sodium sulphate and sodium tripolyphosphate were chosen as poly-anions. The formulated aggregate microparticles were tested for surface morphology, size distribution, in vitro un-harness and drug excipient interaction. Optimized microparticles formulations were carefully chosen on the basis on dissolution studies. The whole device was enteric coated and hydrogel plug was placed in the capsule opening. Results: The pulsatile capsule was found to be acceptable to delay the drug release in small intestinal fluid and eject out the plugin colonic fluid, thus releasing the microparticles into colonic fluid after a lag time criterion of 5 h. To mimic the pH changes along the GI tract, three dissolution media with pH 1.2, 6.8 and 7.4 were sequentially used. FT-IR study established that there was no interaction between the drug and polymer. Among all the formulations, Ivabradine HCl prepared with sodium tripolyphosphate showed prolonged release for a period of 12 h. Conclusion: The obtained results revealed the system's capability to defer the drug release for a programmable period and prevent a sharp increase in blood pressure during the early morning hours when the risk of heart attack is the greatest.
Liquisolid technique is novel concept of the drug delivery via the oral route. This technique is applied to poorly water soluble , water insoluble or lipophilic drugs. According to the new formulation method of liquisolid compact, liquid medication such as solution or suspensions of water insoluble drug in suitable non-volatile solvent can be converted into acceptably flowing and compressible powders by blending with selected powder excipients. The present work endeavour is directed towards the development of liquisolid compact for production of immediate release tablet of water insoluble Nimodipine. Liquisolid compacts were prepared by using polyethylene glycol 300 as the liquid vehicle or non volatile solvent. Crospovidone was used as a superdisintegrating agent and PVP K30 as a binder. Microcrystalline cellulose was used as a absorbing carrier and silicone dioxide as adsorbing coating material. The prepared liquisolid system were evaluated for their micromeretic properties and possible drug-excipients interaction. The FTIR spectra study ruled out any interaction between the drug and excipients in preparation of Nimodipine liquisolid compact. The in-vitro dissolution study confirmed enhance drug release from liquisolid compacts by using USP type I basket in 0.5 % SLS in water. The selected optimal formula released 93.86 % of its content in 30 min which is showing immediate release. The results showed that use of superdisintegrants had remarkable impact on the release rate of Nimodipine from Liquisolid compact, enhancing the release rate of the drug from liquisolid compact.
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