FORMULATION, EVALUATION AND VALIDATION OF ORALLY DISINTEGRATING RIZATRIPTAN BENZOATE TABLET
Department of Pharmaceutical Sciences
Himalayan Institute of Pharmacy and Research Rajawala, Dehradun, Uttarakhand, India
ABSTRACT: The present investigation deals with development of orally disintegrating tablets of Rizatriptan Benzoate to produce the intended benefits. Orally disintegrating tablets of Rizatriptan Benzoate were prepared by wet granulation method to provide faster relief from pain to migraine sufferers. Formulation research is oriented towards safety, efficacy and quick onset of action of existing drug molecule through novel concept of drug delivery. About four formulations for the present study were carried out full factorial design. Kyron 314 was used as super disintegrants, while microcrystalline cellulose and mannitol was used as diluents. Starch was used as binder. The prepared batches of tablets were evaluated for weight variation, hardness, friability, wetting time, drug content and in-vitro dissolution studies. The optimized formulation dispersed in within 15 seconds. It also showed a higher water absorption ratio and 99.67% of drug is released within a minute.
Reference Id: PHARMATUTOR-ART-2548
INTRODUCTION: Oral Disintegrating Tablets (ODT) is solid unit dosage forms, which disintegrate rapidly in the mouth without chewing and in absence of water. ODTs are widely used for pediatric, geriatric and physically weak patients due to their ease of administration. The first ODTs disintegrated through effervescence rather than dissolution, and were designed to make taking vitamins more interesting for children. Dissolution became more effective than effervescence through better manufacturing processes. Tablets designed to dissolve on the buccal mucous membrane were a precursor to the orally disintegrating tablets. This dosage form was intended for drugs that yield low bioavailability through the digestive tract but are difficult to administer parenterally, such as steroids and narcotic analgesics. Absorption through the cheek allows the drug to bypass the digestive tract for instant systemic distribution.
Advantages of ODTs:
1. Increased bioavailability due to pregastric absorption.
2. Improved safety due to low risk of choking or suffocation during oral administration.
3. They are easy to consume and as such are convenient for such patients as "the elderly, stroke victims, and bedridden patients, patients affected by renal failure, and patients who deny swallowing, such as pediatric, geriatric, and psychiatric patients".
Disadvantages Of ODTs:
1. Cost-effective production process.Expensive packaging of oral film.
2. Lack of physical resistance in standard blister packs.
Technologies used to prepare:
1. Direct compression: Easiest way to manufacture tablets Low manufacturing cost, conventional equipment’s and limiting no. of processing steps. It is essential to choose a suitable and an optimum concentration of disintegrates to ensure quick disintegration and dissolution. Superdisintegrants are the rooky substances which are more effective at lower concentration with greater disintegrating efficiency and mechanical strength.
2. Sublimation: The slow dissolution of the compressed tablet containing even highly soluble ingredients is due to the low porosity of the tablets. The volatile materials were then removed via sublimation, which produces porous structures. Additionally, several solvents (e.g. Cyclohexane benzene) can be also used as pore forming agents.
3. Tablet moulding: In this method, tablets are prepared by using water soluble ingredients so that the tablet dissolves completely and rapidly. The powder blend is moistened with a water– alcoholic solvent and is molded into tablet under pressure lower than that used in conventional tablet compression. The solvent is then removed by air drying.
4. Freeze drying/ Lyophilization: A process in which water is sublimated from the product after freezing Lyophilization is a pharmaceutical technology which Allows drying of heat sensitive drugs and biological at low temperature under conditions that allow removal of water by sublimation. Lyophilization results in preparation, which is highly porous with a very high specific surface area.
5. Mass extrusion: In this method active blend is softened using the solvent mixture of water-soluble polyethylene glycol and methanol and then subsequent expulsion of softened mass through the extruder or syringe is made to get a cylinder of the product into even segments using heated blade to form tablet. The dried cylinder can also be used to coat granules for bitter drugs.
6. Spray drying: In this technique, gelatin can be used as a supporting agent and as a matrix, mannitol as a bulking agent and sodium starch glycolate or crosscarmellose or crospovidone are used as superdisintegrants. Tablets manufactured from the spray-dried powder have been reported to disintegrate in less than 20 seconds in aqueous medium.
Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the accurate level of compliance at all stages. In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results.
Process validation for solid oral dosage form in the pharmaceutical industry is required by the current good manufacturing practices for finished pharmaceutical products. According to FDA’s guidelines process validation defined as follows:“Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre – determined specification and quality characteristics.”
Benefits of Process validation:
1. Compliance with government regulation.
2. Harmonization of global GMP’s.
3. Internationally accepted quality is attained.
4. Decreased risk of process variables.
5. Built in quality & hence the small size sample in production batches.
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