PLAN OF WORK Plan of Work

Review of Literature Selection of drug and excipients Selection & Procurement of API, polymers, other excipients and instruments Drug-excipients compatibility study Preformulation studies27: a) Bulk density (b): It includes inter and intra particle spaces which is determined by measuring cylinder. Granules passed through US standard sieve number 22 #. The weighed amount (W) of granules are transferred in 100 ml cylinder and volume is measured (Vb).

b) Tapped density: Granules passed through US standard sieve number 22 #. The weighed amount (W) of granules is transferred in 100 ml cylinder. This cylinder is tapped at 2 second interval on hard surface from height of 1 inch until constant volume (Vt) achieved.

c) Hausners Ratio: It is the ratio of tapped density to bulk density.

a) Carrs index (%CI): it is percentage compressibility which gives indication of compressibility of powders.

Where, TD = tapped density, BD = bulk density

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Formulation fast dissolving Tablet Evaluation of fast dissolving Tablet 1. Organoleptic characteristics The general appearance of a tablet, its visual identity and over all "elegance" is essential for consumer acceptance and tablet's size, shape, colour, presence or absence of an odour, taste, surface texture, physical flaws and consistency and legibility of any identifying marking. 2. Weight variation: Indian Pharmacopoeia procedure for uniformity of weight was followed, twenty tablets were taken and their weight was determined individually and collectively on a digital weighing balance. The average weight of one tablet was determined from the collective weight. The weight variation test would be a satisfactory method to determining the drug content uniformity. 3. Friability: Friabillator consist of a plastic-chamber that revolves at 25 rpm, dropping those tablets at a distance of 6 inches with each revolution. The tablets were rotated in the friabillator for at least 4 minutes. At the end of test tablets were dusted and reweighed, the loss in the weight of tablet is the measure of friability and is expressed in percentage as Friability =[(Initial weight- Final weight) / (Initial weight)] x 100 4. Hardness : Hardness of tablet is defined as the force applied across the diameter of the tablet in the order to break the tablet. The resistance of the tablet to abrasion or breakage under condition of storage transformation and handling before usage depends on its hardness. Hardness of the tablet of each formulation was determined using Pfizer Hardness tester.

5. Disintegration Time: For determination of disintegration time, one tablet was placed in each tube of disintegration apparatus (Electrolab ED 2L, India). Disintegration test was carried out using distilled water as disintegrating at 24 2oC. 6. Water absorption Ratio:

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A piece of tissue paper folded twice was placed in a small Petridish containing 6 ml of water. A tablet was put on the paper & the time required for complete wetting was measured. The wetted tablet was then weighed. Water absorption ratio, R, was determined using following equation, R = 10 (wa/wb) Where, wa is weight of tablet before water absorption & wb is weight of tablet after water absorption.

7. In vitro Dissolution test: The development of dissolution methods for FDTs is comparable to the approach taken for conventional tablets and is practically identical. Dissolution conditions for drugs listed in a pharmacopoeia monograph, is a good place to start with scouting runs for a bioequivalent FDT. Other media such as 0.1 M HCl and buffer (pH 4.5 and 6.8) should be evaluated for FDT much in the same way as their ordinary tablet counterparts. It has been suggested that USP 2 paddle apparatus is the most suitable and common choice for orally disintegrating tablets, with a paddle speed of 50 rpm commonly used.

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