Saju, R (2018) Formulation Development and Evaluation of Mouth Dissolving Tablets of Diltiazem Hydrochloride by Direct Compression Method. Masters thesis, Edayathangudy G.S.Pillay College of Pharmacy, Nagapattinam.
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Abstract
In some cases of Hypertension Quick onset of action is desired, the Fast dissolving tablets plays a vital role. Fast dissolving tablets have much number of advantages over the conventional tablets like rapid disintegration, faster dissolution, Ease of administration and quick onset of action etc. • In the present research work, Diltiazem Hydrochloride Fast dissolving tablets were prepared using Super disintegrants like Croscarmellose sodium, Crospovidone and Sodium starch Glycolate in different concentrations by Direct Compression method. • Diltiazem Hydrochloride Fast dissolving Tablets prepared were evaluated for Pre- compressional and Post-compressional parameters. The Pre-compressional parameters evaluated are bulk density, true density, angle of repose and percent porosity; where the angle of repose of all the formulations is below 30o indicating free flowing. • Post-compression parameters like Hardness, weight variation, Percent friability, In-Vitro dispersion, Drug content uniformity and In-vitro drug release studies were carried out for all the formulation. All the Formulation given the result within the official limits. • The drug and excipients interaction study is carried out by taking Infrared Spectrum of Pure drug and Best formulation (DLTF6). There is no change in the structure indicating drug is in intact form. • Formulation DLTF6 in which Crospovidone (8mg) used, shows less Dissolution time i.e. 15 seconds and highest Dissolution rate 99.9% release in 8 minutes which is considered as Formulation among all. CONCLUSION: The concepts of formulating Fast Dissolving Tablets of Diltiazem Hydrochloride offers a suitable practical approach in serving desired objectives of faster disintegration and dissolution characteristics. In the present work, Fast dissolving tablets of Diltiazem Hydrochloride were prepared by Direct Compression Technique using Crospovidone, Croscarmellose Sodium starch glycolate as Super disintegrants. All the Fast dissolving tablets of Diltiazem Hydrochloride prepared were subjected to Drug content Uniformity, weight variation, Hardness, Thickness, Friability, Disintegration and Dissolution studies. • Precompression parameters like Bulk density, Tapped density, percentage Porosity, Angle of repose. The result of angle of repose indicates free flowing characteristics of granules. • Hardness of the tablet of every batch was in the range of 2.8 to 4.0Kg/cm2. • Friability of all the tablets was less than 1%. • Weight variation test results of every batch showed that the weight of each tablet of the batch tested was within the range ±7.5%. • All the tablets formulated using Croscarmellose sodium, Crospovidone and Sodium starch glycolate disintegrated within 3minutes fulfilling the official limits of the Fast dissolving tablets. • IR Spectral analysis suggests that the characteristic peaks of the Pure drug Diltiazem Hydrochloride exist in the Spectra of Formulation prepared indicting the intactness of the drug is in intimate contact with the additives. It has not undergone any chemical interaction with the excipients used in the development of Diltiazem Hydrochloride Fast dissolving tablets. • Drug content uniformity study results showed that the drug Diltiazem Hydrochloride was uniformly distributed throughout the formulation of every batch. • t70% value that is the time required /taken to the release 70% of the drug were determined for every batch, the formulation DLTF6 shows every low t70% i.e. 2.6minutes to release 70% of the drug. • Finally, we can conclude that, among various formulations prepared, the Fast dissolving tablets prepared, using Crospovidone (8mg) DLTF6, disintegrated rapidly and gave highest dissolution of Diltiazem Hydrochloride within a short period of time.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg No.261511153 |
| Uncontrolled Keywords: | Mouth Dissolving Tablets ; Diltiazem Hydrochloride ; Direct Compression Method ; Formulation Development ; Evaluation. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Subramani R |
| Date Deposited: | 27 Jun 2019 02:12 |
| Last Modified: | 27 Jun 2019 02:12 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10622 |
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