You are hereA FORMULATION AND DEVELOPMENT OF ORODISPERSIBLE TABLET OF LORNOXICAM

A FORMULATION AND DEVELOPMENT OF ORODISPERSIBLE TABLET OF LORNOXICAM


About Authors:
Mr.Sanjay wasudeo upare*, Dr.A.V.Chandewar, Dr.M.D.Kshirsagar, Mr.U.S.Koli and Mr.H.K.Pokale
M-Pharm IV semester (Pharmaceutics department)
Pataldhamal Wadhwani college of Pharmacy,
Yavatmal

*uparesanju81@gmail.com

ABSTRACT:
Lornoxicam is a non steroidal anti-inflammatory drug with analgesic properties. The purpose of this study was to develop a taste masked oral disintegrating tablet of poorly soluble Lornoxicam by direct compression technique with β-cyclodextrin (BCD) complexes using various super disintegrants like sodium starch glycolate, crospovidone and L-Hpc. Prepared tablets were evaluated for different properties like drug content, hardness, friability, disintegration time and in vitro dissolution study. The different formulations showed disintegration time between 21 to 33.66 s. Drug release showed time between the ranges of 5 to 30 min. Among all the formulations, L1 showed 97.79% drug release within 30 min. Thus, L1 was considered best among the other formulations.. The tablets showed enhanced dissolution hence better patient compliance.

Reference Id: PHARMATUTOR-ART-1344

INTRODUCTION:
Over a decade, the demand for development of orally disintegrating tablets (ODTs) has enormously increased as it has significant impact on the patient compliance. Orally disintegrating tablets offer an advantage for populations who have difficulty in swallowing. It has been reported that Dysphagia (difficulty inswallowing) is common among all age groups and more specific with pediatric, geriatric population along with institutionalized patients and patients with nausea, vomiting, and motion sickness complications. ODTs with good taste and flavor increase the acceptability of bitter drugs by various groups of population. More than 50% of pharmaceutical are administered orally for several reason and undesirable taste is one of the formulation problem encountered with such oral products.2 Taste of pharmaceutical product is important parameter in governing compliance. Thus taste masking of oral pharmaceutical has become important tool to improve patient compliance and the quality of treatment especially in pediatrics. In inclusion complex formation, the drug molecule fits into the cavity of a complexing agent i.e., the host molecule forming a stable complex. The complexing agent is capable of masking the bitter taste of the drug by either decreasing its oral solubility on ingestion or decreasing the amount of drug particles exposed to taste buds thereby reducing the perception of bitter taste. Vander Waals forces are mainly involved in inclusion complexes. β-cyclodextrin is most widely used complexing agent for inclusion type complexes. It is sweet, nontoxic, cyclic oligosaccharide obtained from starch. Strong bitter taste of carbapentane citrate syrup was reduced to approximately 50% by preparing a 1:1 complex with cyclodextrin. The suppression of bitter taste by cyclodextrin was in increasing order of alpha,gamma, beta cyclodextrin. Lornoxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class with analgesic, antiinflammatory and antipyretic properties. The mode of action of Lornoxicam is partly based on inhibition of prostaglandin synthesis (inhibition of the cyclooxygenase enzyme). Lornoxicam is absorbed rapidly and almost completely from the gastro-intestinaltract. Lornoxicam is very bitter in taste. Therefore to provide this drug in a more accessible and patient compliant form, in the present study an attempt has been made to mask its bitter taste and formulate it into oral disintegrating tablet.

MATERIALS AND METHODS:
Lornoxicam was gift sample from Luin pharma industries Ltd,Aurangabad. Sodium starch glycolate, crospovidone, L-Hpc, β-cyclodextrin, directly compressible mannitol (Pearlitol SD 200), microcrystalline cellulose and aspartame were obtained as a gift sample from MICRO Labs Pvt. Ltd, Vadodara. All the other chemicals used were of analytical reagent grade.
(i) Preparation of complex of Lornoxicam with β- cyclodextrin

Physical mixture method

The required molar (1:3) quantities of drug and β-cyclodextrin were weighed accurately and mixed together thoroughly in mortar with vigorous trituration for about 3 hrs. These mixtures were then passed through sieve no. 44 and finally were stored in airtight containers till further use.
(ii) Characterization of complex for drug content

Drug content was determined by dissolving 25 mg of complex in suitable quantity of 0.1N HCl and analyzed 1mL of appropriately diluted sample at 376
nm using UV-vis spectrophotometer, Shimadzu 1700

Drug : β- Cyclodextrin

% Drug Content ± S.D

1:3

100.48 ± 0.46

1. Drug Content Estimation:
Drug content was determined by dissolving 25mg of complex  in suitable quantity of 0.1N HCl and analyzed 1ml of appropriately diluted sample at 376nm using UV-vis spectrophotometer, shimadzu 1700

2. Evaluation of Taste of Inclusion complex:
Taste of inclusion complex was checked by time intensity method. For this purpose 10 human volunteers were selected. In this method a sufficient quantity of sample was held in mouth for 10 seconds and volunteers were asked to evaluate the complex for taste. Bitterness levels were recorded immediately. Bitterness values, are based on a 0-3 scale
3 being – strong bitter
2 being – moderate bitter
1 being – slight bitterX being – threshold bitter
0 being – tasteless
These volunteers were instructed not to swallow the granules, which were placed on the tongue. They were instructed to thoroughly gargle their mouth with distilled water after the completion of test.

The results are revealed in Table No.8.1

Volunteers

Bitterness Level after 10 sec

1

0

2

0

3

1

4

0

5

1

6

0

7

0

8

0

9

0

10

1

FORMULATION OF ORODISPERSIBLE TABLET
Orodispersible  tablets were prepared using  Lornoxicam and β-cyclodextrin complexes which were prepared by Physical mixture method, variable concentrations of superdisintegrants and other excipients. The powder blends equivalent to the 16 mg of drug were sieved and mixed except for the lubricating agent, mixing of all components and then directly compressed using 8mm concave punches. Tablets were evaluated for various tablet parameters.

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