Current Issue : April - June Volume : 2016 Issue Number : 2 Articles : 4 Articles
This research project consisted in developing a new formulation for the direct compression of senna ââ?¬â??an intrinsically non-compressible material originating from the dried pods of a plant named Cassia acutifolia. The challenge of finding adequate excipients to compress senna was combined to the challenge of maintaining similar weight and appearance to that of the currently marketed senna tablets. These challenges stemmed from the fact that the current formulation is composed of 80% senna, which created significant limitation for introducing compressible excipients. To overcome these challenges, currently marketed senna tablets are generally manufactured through wet granulation prior to compression, a process that is rather laborious and costly. The water acts as a binder in the granulation process, which allows the tablets to maintain their strength and integrity. However, wetting, drying and testing the granules for assay involves considerable time, labor and machinery as compared to the direct compression process. In addition to cost savings, direct compression does not require water or heat in the process, which could potentially reduce hydrolysis and oxidation of the active principle and enhance product stability. The development of senna formulation for direct compression was conducted in six experimental designs, where batches of senna tablets were manufactured as per specific matrices and analyzed for hardness, friability, disintegration, appearance, average weight, moisture and assay, as the project progressed. The results were compared to defined specifications which were based on the currently marketed senna tablets. A new formulation was found in the sixth experimental design, where optimal levels of hydroxypropyl cellulose, hydroxyethyl cellulose, lactose and croscarmellose sodium were identified. Tablet properties emerging from this formulation met all defined specifications at the time of manufacture and also after one month, three months and six months accelerated stability conducted as per the International Conference on Harmonisation guidelines. In conclusion of this project, a successful formulation for the direct compression of senna was discovered through \"Design of Experiments\" and \"Quality by Design\" methodologies. Furthermore, this efficient approach could be used again to develop other formulation presenting similar challenges and could potentially accelerate product launch in prospective pharmaceutical markets....
The objective of the current research article is to provide a comprehensive review of excipients\nimpact on the stability of the drug product and their implications during the product development.\nRecent developments in the understanding of the degradation pathways further impact methodologies\nused in the pharmaceutical industry for potential stability assessment. The formation of\ndrug excipient adducts was very common based on the sensitive chemical moieties in the drugs\nand the excipients. The formation of the impurities was not limited to drug related impurities but\nthere were several possibilities of the drug-excipient adduct formations as well as excipient impurities\nreaction with Active Pharmaceutical Ingredients. Identification of drug degradation in\npresence of excipients/excipient impurities requires extensive knowledge and adequate analytical\ncharacterization data. Systematic literature review and understanding about the drug formulation\nprocess, give you a smooth platform in establishing the finished product in the drug market.\nThis paper discusses mechanistic basis of known drug-excipient interactions with case studies and\nprovides an overview of common underlying themes in solid, semisolid and parenteral dosage\nforms....
The present work was aimed to develop novel oral antihypertensive sustained release intestinal mucoadhesive tablets of valsartan using novel natural polymer isolated from Coccinia grandis and chitosan. The tablets were prepared by using different concentration of polymer of Coccinia grandis and chitosan by wet granulation method. For the study purpose, both of above polymer were selected as the model polymers. The purpose of present study was to evaluate Coccinia grandis and chitosan for mucoadhesive properties and to formulate intestinal mucoadhesive tablet of valsartan (model drug) to keep the dosage form in the small intestinal region for about 24 hours for the treatment of hypertension and heart failure. Characterization of drug and compatibility among the formulation components was assessed by FTIR analysis. Two different methods were developed to isolate polymer from the fruits of Coccinia grandis. Compressed tablets were evaluated for various parameters like weight variation, drug content, hardness, friability, in-vitro drug release. Prepared core tablets were press coated with cellulose acetate phthalate (CAP) in different ratios. After optimizing coating ratio, prepared tablets were evaluated for hardness, friability, weight variation, thickness, in-vitro dissolution study, ex-vivo residence time, ex-vivo mucoadhesive force and drug content, swelling behaviour. A 32 randomized full factorial design was used. Amount of novel polymer (X1) and amount of chitosan (X2) were selected as independent variables. The ex-vivo residence time of tablet and cumulative percentage drug release at 24 hours (Q24), were selected as dependent variables. The kinetic data obtained from in-vitro drug release studies of optimized batch indicates that the drug release data not only showed good fit into the higuchi equation (R2 = 0.992) but also partially fitted in zero order equation (R2 = 0.974). The developed optimized batch containing 7.5% w/v novel natural polymer and 2.5% w/v chitosan was selected as an optimized batch as it has shown 97.64% drug release and ex-vivo residence time for about 24 h....
The demand for fast disintegrating tablets (FDT) has been growing during the last decade especially for the children and the elder people who have swallowing difficulties. Lamivudine, a retroviral drug (2', 3'-dideoxy-3'- thiacytidine, commonly called 3TC) is a potent nucleoside analog reverse transcriptase inhibitor (nRTI). It is used for treatment of chronic hepatitis B at a lower dose than for treatment of HIV. Oral bioavailability of the drug is around 86% and having half life of 5-7 hrs. In the present investigation an attempt has been made to prepare fast disintegrating tablets of lamivudine by using super disintegrants like crospovidone, ludiflash along with novel co -processed excipients by direct compression method. Various formulations were prepared using different concentrations of superdisintegrant and coprocessed excipients. The pre and post compression parameters were evaluated for each formulation and the results were found satisfactory. The tablets containing crospovidone and co-processed excipient mixture ludiflash having total crospovidone concentration of 4.5% showed disintegration time, 16 sec and higher drug release of 96.33% in 30 min. It can be concluded that the usage of optimum concentration (4.5%) mixture of co-processed disintegrants were successful in developing lamivudine FDTs....
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