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概要

Formulation and Evaluation of Mouth Dissolving Tablets Prepared by Micronized Terbutaline Sulfate and Using Co-processed Superdisintegrants by Direct Compression Method

Zahabia Manzoor, Haaris Inam Khan*, Saddiq ul Abidin, Fatima Maqsood, Ahsan Farooq Khan, Syed Muhammad Sikandar, Alina Fakhar, Khalid Shahzad

The present work contains details of formulating and evaluation of mouth dissolving tablets of micronized terbutaline sulphate by using co-processed superdisintegrants and taste masking agent (flavors and ion exchange resin) with an aim to get a dosage form having fast disintegration.

Terbutaline sulphate first pass through size reduction technique which leads to increase in surface area and increased in oral absorption of the drug. As a part of pre-formulation study, the physicochemical compatibility study of the drug with different excipients was done and drug-excipient interaction was assessed from thermal analysis by using differential scanning calorimetry indicated absence of interactions between the selected excipients for the study. Moisture absorption study of the drug indicated that the drug is non-hygroscopic. Thermal (stress) Stability of the drug was also assessed and found to be satisfactory.

Factorial Design of research methodology was used for formulation design study by keeping consideration for variable ingredients which directly affect the disintegration and palatability of the formulation. Direct compression method was employed in the manufacturing of tablets with different superdisintegrants and flavours and their concentrations, but two formulations were also designed using ion exchange complex method for masking the taste by wet granulation method.

The selected formulations (four) were subjected for complete (detailed) evaluation of critical quality attributes like uniformity of weight, hardness, thickness, friability, disintegration time, wetting time (water uptake (swelling) and erosion studies), drug content and dissolution profile.