Development and Assessment of Orally Disintegrating Tablet Containing Montelucast Sodium
Abstract
Montelukast sodium is widely used in treatment of asthma and other allergic disorders. The Montelukast sodium is a water insoluble drug but need quick action. So we planned a mouth dissolving tablet of Montelukast sodium. Further we evaluated functionality of co-processed super disintegrants over super disintegrant alone. Formulation f1 to f11 were designed to change ratios and amount of Super disintegrants and co-processed super disintegrants. The prepared tablets were evaluated for hardness, friability, weight variation, disintegration time, and in vitro dissolution studies. On the basis of evaluation parameter formulation f9 having co-processed superdisintegrant Crospovidone and SSG (1:3 ratio) in 6% w/w concentration to overage weight of tablet was finally selected as optimized formulation and it was concluded that functionality of co-processed super disintegrant is better than super disintegrant alone.
Introduction
Despite of so much of advancements in various delivery system developed for administration of various drugs through different routes such as oral, parental, transdermal and nasal etc., the oral route is considered as the preferred route of administration which includes painless, ease of administration, patient friendly and so on74. Several new technologies had been developed for oral delivery is being available to address to improve the patient compliance74. Fast dissolving drug delivery system (FDDS) is gaining popularity in pharmaceutical companies as they are new drug delivery technique in order to provide the patient with medicine without Corresponding obstacles in swallowing74. FDDS include tablets and films. Fast dissolving tablets are designed in such a way that they disintegrate and then swallowed without the need of water as compared to other conventional dosageform74. Films are the small polymeric
strips which when placed on the mucosal surface rapidly dissolve within a fraction of seconds in order to release the active ingredients without the consumption of water 75.
1.2.1 Ideal Characteristics of Fast Dissolving Drug Delivery System76
- Require no water for administration
- Cost effective production methods
- Leave minimal or no residue in mouth
- Dissolve within a fraction of seconds
- Have a pleasant mouth feel
1.2.2 Advantages of FDDS77
- Ease of administration
- Water consumption is not required
- Rapid dissolution and absorption of drug
- Bioavailability is increased
1.2.3 Fast Dissolving Tablets
Orally disintegrating dosage forms has to be placed in mouth and then get dispersed insaliva without the need of water. Orally disintegrating tablets are also called as oral disperse, mouth dissolving, rapidly disintegrating, fast melt, and quick dissolve system77.
1.2.4 Patented Technologies for Fast Dissolving Tablets
New FDDS technologies are addressing many pharmaceutical companies to enhance the lifecycle management to convenient dosing for geriatrics and peadiatrics78.
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2.1 Materials Used
| S. No. | Materials used | Manufactured By |
|---|---|---|
| 1 | Montelukast sodium | Akon Pharma. Pvt. Ltd. |
| 2 | Magnesium Stearate | Titan biotech Limited. |
| 3 | Talc | Loba chemie Pvt. Ltd. |
| 4 | Microcrystalline cellulose(ph 101) | Sd-fine Pvt. Ltd. |
| 5 | Crospovidone | E-Merck Pvt. Ltd. |
| 6 | Sodium starch glycolate | Yarrow Pvt. Ltd. |
| 7 | Flavour | Rankem Pvt. Ltd. |
| 8 | Mannitol | E-Merck Pvt. Ltd. |
| 9 | β -cyclodextrine | Loba chem. Pvt. Ltd. |
| 10 | Methanol | Rankem Pvt. Ltd. |
| 11 | Ethanol | Rankem Pvt. Ltd. |
| 12 | Distilled water | Milli pore water purifired. |
| 13 | SLS | Rankem Pvt. Ltd. |
| 14 | Acetonitrile | Rankem Pvt. Ltd. |
| 15 | Chloroform | Rankem Pvt. Ltd. |
| 16 | Acetone | Rankem Pvt. Ltd. |
| 17 | Methylene chloride | Rankem Pvt. Ltd. |
| 18 | Isopropyl alcohol | Lab chem.Industries.Mumbai |
Maheshwari Vishwakarma, Dr. Nidhi Tyagi, Dr. Prashant Kumar Katiyar, Mr. Seraj Alam Siddique, Development and Assessment of Orally Disintegrating Tablet Containing Montelucast Sodium, Maheshwari Vishwakarma/Afr.J.Bio.Sc. 6(Si3) (2024) 2807-2826, ISSN: 2663-2187, doi: 10.33472/AFJBS.6.Si3.2024.2807-2826
Read also our introduction article on Orally Disintegrating Tablets (ODTs) here:
