FORMULATION AND EVALUATION OF CHEWABLE TABLETS OF MEBENDAZOLE BY DIFFERENT TECHNIQUES

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About Authors:
Fiza Farheen*, Sudhir Bharadwaj
Department of Phrmaceutics, Shri Ram College of Pharmacy,
Banmore, Morena (M.P.)
fizafarheen31@gmail.com

Abstract
The objective of the study was to develop an effective formulation of mebendazole chewable tablets. Mebendazole is a benzimidazole derivative with broad spectrum anthelemthic activity and excellent tolerability. Orally it is rapidly absorbed and metabolized tohydroxy  andhydroxyamino, which may be responsible for its anthelmenthic action. It is widely used in the treatment of worm infestations in both humans and animals. Mebendazole chewable tablets (200 mg) were prepared by three methods viz. non aqueous granulation, aqueous granulation and direct compression and were named as NAG, AG and DC respectively. Tablet prepared by these three methods were evaluated by different parameters such as average weight, hardness, carr’s index, tapped density, friability, disintegration, content uniformity test, in-vitro dissolution etc. All the parameters were found within the specifications. The study on the dissolution profile revealed that product ‘DChad faster dissolution rate while compared to remaining batches and marketed product. Assay values were within the limits of 90% to 110%.

REFERENCE ID: PHARMATUTOR-ART-2171

PharmaTutor (ISSN: 2347 - 7881)

Volume 2, Issue 6

Received On: 31/03/2014; Accepted On: 05/04/2014; Published On: 01/06/2014

How to cite this article: F Farheen, S Bharadwaj; Formulation and Evaluation of Chewable Tablets of Mebendazole by Different Techniques; PharmaTutor; 2014; 2(6); 183-189

INTRODUCTION
Chewable tablets are designed for use by the children and such persons who may have difficulty in swallowing the tablets.[1] These are intended to be chewed in the mouth prior to swallowing and are not intended to be swallowed intact.[2] Additionally, chewable tablets facilitate more rapid release and hence more rapid absorption of active ingredients and provide quick onset of action.[3] Hence it was decided to formulate mebendazole chewable tablet to improve the compliance in children and to improve the solubility and dissolution.

mebendazole is benzimidazole derivative that has been widely used in the treatment of worm infestations in both humans and animals. mebendazole is widely employed in the treatment of intestinal nematode infection. mebendazole has low water solubility, limiting its oral absorption and resulting in a lower bioavailability.[4] Administration of drugs through oral route is the most common and the easiest way to administer a drug. But it is a challenge in children who have not yet learned to swallow tablets. Hence it was decided to formulate mebendazole chewable tablet to improve the compliance in children. Chewable tablets are the tablets which are required to be broken and chewed in between the teeth before ingestion. These tablets are given to the children who have difficulty in swallowing and to the adults who dislike swallowing.[5]

The advantages of chewable tablets include palatability, stability, precise dosing, portability and ease of delivery. The available literature suggests that chewable tablets provides a safe, well-tolerated alternative to traditional pediatric drug formulations and offer significant advantages in children with two years of age and above. In the present paper mebendazole chewable tablets were prepared by three different methods and all the three batches were evaluated. The main objective of the present study was to formulate and evaluate mebendazole chewable tablet by different technique and to evaluate these using different parameters.[6]

MATERIALS AND METHODS
Materials

Pure drug sample of mebendazole was procured from sequent scientific Ltd, Bangalore. All other ingredients viz. Lactose, Starch, Sodium starch glycolate, Isopropyl alcohol. Sodium Saccharine etc. used were of pharmaceutical grade.

Methods
(a.) Nonaqueous Granulation

All the ingredients were separately weighed and sifted using mesh no. 40. mebendazole, Lactose monohydrate, Starch and Sodium Starch Glycolate was mixed in a poly bag for ten minutes. For the preparation of binder dispersion, isopropyl alcohol was taken in a beaker, stirred with glass rod to disperse starch until no lumps were observed. Then the above dry mixture was granulated with binder solution and dried in the tray drier at the temperature of 40-500 0C until the moisture reduce down to NMT-2%. The dried granules were passed through mesh no. 30, Mannitol (Perlitol200) through mesh no.30. Sodium Saccharine, Carmofine color and pineapple flavor were passed through mesh no.100. All these were finally added to the dried granules and blended for ten minutes. The above blend was lubricated with Magnesium stearate, Talc, Aerosil for two minutes. The powder blends was evaluated for the flow properties and were found to be good. The evaluated blend was compressed into tablets to get tablets of 513 mg weight each. A minimum of fifty tablets were prepared for each batch.

(b.) Aqueous Granulation
All the ingredients were separately weighed and sifted using mesh no. 40. Mebendazole, Lactose monohydrate, Starch and Sodium starch glycolate were mixed in poly bag for ten minutes. For the Preparation of binder dispersion purified water was taken in a beaker, stirred with glass rod to disperse starch until no lumps were observed. Then the above dry mixture was granulated with binder solution and dried in the tray drier at the temperature of 40-500C until the moisture reduces down to NMT-2%. The dried granules were passed through mesh no.30. Then Mannitol (pearlitol200) was passed through mesh no.30, Sodium saccharine, Carmofine and pineapple flavor were passed through mesh no.100. All these were then added to the dried granules and blended for ten minutes. Finally the above blend was lubricated with Magnesium stearate, Talc, Aerosil for two minutes. The powder blend was evaluated for the flow properties and was found to be good. The evaluated blend was compressed into tablets to get tablets of 513 mg weight each. A minimum of fifty tablets were prepared for each batch.

(c.) Direct Compression
All the ingredients were separately weighed and sifted using mesh no. 40. Mebendazole, Lactose monohydrate, Starch and Sodium starch glycolate, Mannitol (pearlitol200) were passed through mesh no.30. Sodium saccharine, Carmofine color and pineapple flavor were passed through 100 mesh and required quantities were blended for ten minutes in poly bag. Finally the above blend was lubricated with Magnesium stearate, Talc and Aerosil for two minutes. The powder blend was evaluated for the flow properties and was found to be good. The evaluated blend was compressed into tablets of 513 mg weight each. A minimum of fifty tablets were prepared for each batch. The manufacturing formulas for the tablets used in the above three methods is given in table I.

EVALUATION OF TABLETS

(a.) General appearance[7]
The general appearance of all tablets, its visual identity and overall elegance is essential for consumer acceptance. The formulated chewable tablets were evaluated for size, shape, organoleptic characters such as, colour, odor and taste.

(b.) Dimensions[8]
The shape and dimensions of compressed tablets were determined by the type of tooling during the compression process. At a constant compressive load, tablet thickness varies with changes in die fill, particle size distribution and packing of the powder mix being compressed and with tablet weight. While with a constant die fill, thickness varies with variation in compressive load. Tablet thickness is consistent from batch to batch or within a batch only if the tablet granulation or powder blends is adequately consistent in particle size and particle size distribution, Consistent length of punch tooling, Tablet press and good working conditions Thickness and diameter of the tablets were measured using digital vernier caliper. The values of thickness were used to adjust the initial stages of compression. Tablet thickness should be controlled within a ±5% variation of a standard value. Also the thickness must be controlled to facilitate packaging.

(c.) Weightvariation[9]
Twenty tablets were weighed individually and all together. Average weight was calculated from the total weight of all tablets. The individual weights were compared with the average weight. The percentage difference in the weight variation should be within the permissible limits. The percent deviation was calculated using the following formula:-

Percentage deviation = [(Individual weight-Average weight) /Average weight]×100

Any deviation in the weight of tablet leads to either under medication or over medication. So, every tablet in each batch should have a uniform weight. Corrections were made during the compression of tablets to get uniform weight. The USP has provided limits for the average weight of uncoated compressed tablets. These are applicable when the tablet contains 50mg or more of the drug substance or when the latter comprises 50% or more, by weight of the dosage form. Twenty tablets were weighed individually and the average weight was calculated. The individual tablet weights are then compared to the average weight. Not more than two of the tablets must differ from the average weight by not more than the percentages stated. No tablet must differ by more than double the relevant percentage.

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