Formulation and Evaluation of Bisacodyl Enteric Coated Tablets

Arun Venkatesh, S (2014) Formulation and Evaluation of Bisacodyl Enteric Coated Tablets. Masters thesis, C L Baid Metha College of Pharmacy, Chennai.

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Drugs are rarely administered as pure chemical substances alone and are almost always given as formulated preparations or medicines. The development of dosage forms draws on the discipline of biopharmaceutics, which integrates an understanding of formulations, dissolution, stability, and controlled release (pharmaceutics); absorption, distribution, metabolism, and excretion (pharmacokinetics, PK); concentration-effect relationships and drug-receptor interactions (pharmacodynamics, PD); and treatment of the disease state (therapeutics). Drug is the substance used to cure, treat, restore the health state, or optimize a malfunction. Formulation of a dosage form typically involves combining an active ingredient and one or more excipients; the resultant dosage form determines the route of administration and the clinical efficacy and safety of the drug. Optimization of drug doses is also critical to achieving clinical efficacy and safety. Preformulation studies has been performed to study the nature of API and compatibility of API with excipients by physical observation and FT-IR studies. The results showed that there was no interaction between API and all the excipients selected. Enteric coated tablets of bisacodyl were successfully formulated by wet granulation method using the selected excipient with required quantities. The formulated tablets were evaluated for both pre-compression and post-compression parameters like bulk density, tapped density, compressibility index, hausner’s ratio,moisture content, hardness, thickness, disintegration time and invitro dissolution and assay as per requirements of standards. The results were found to be satisfactory with the pharmacopoeial specifications. Among all the entire batches, formulation (F7) is the best formulation which complies all the pharmacopoeial specifications. The best formulation is selected based on the invitro dissolution data when compared with that of innovator product using the similarity factor. The most satisfactory formulation has been subjected to Accelerated stability studies as per ICH guidelines for 3 months at 40˚C±2˚C / 75% ±5% RH. The results of stability studies shows no significant changes in the physical parameters of the tablets, drug content and invitro dissolution data until the end of 3 months from the initial values. Hence it is concluded that the formulated bisacodyl enteric coated tablets were stable and this study fulfilled all the pharamcopoeial specifications.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Formulation ; Evaluation ; Bisacodyl ; Enteric Coated Tablets.
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 14 Jul 2017 06:13
Last Modified: 15 May 2018 23:42

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