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Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization.

Gupta MM, Gupta N, Chauhan BS, Pandey S - J Pharm (Cairo) (2014)

Bottom Line: Among the two resins, Kyron-T-104 was selected for further studies because of high drug loading capacity, low cost, and better drug release profile.An ion exchange resin complex was prepared by the batch technique and various parameters; namely, resin activation, drug: resin ratio, pH, temperature, and stirring time, and swelling time were optimized to successfully formulate the tasteless drug resin complex (DRC).The stability studies were carried out for the optimized batch for three months and it showed acceptable results.

View Article: PubMed Central - PubMed

Affiliation: School of Pharmacy, Faculty of Medical Sciences, The University of the West Indies, St. Augustine, Trinidad and Tobago ; Department of Pharmaceutics, Jaipur College of Pharmacy, Sitapura, Tonk Road, Jaipur, Rajasthan 302022, India.

ABSTRACT
The aim of this study was to prepare fast disintegrating combination tablet of taste masked Levocetrizine dihydrochloride and Montelukast sodium by using direct compression method. To prevent bitter taste and unacceptable odour of the Levocetrizine dihydrochloride drug, the drug was taste masked with ion exchange resins like Kyron-T-104 and Tulsion-412. Among the two resins, Kyron-T-104 was selected for further studies because of high drug loading capacity, low cost, and better drug release profile. An ion exchange resin complex was prepared by the batch technique and various parameters; namely, resin activation, drug: resin ratio, pH, temperature, and stirring time, and swelling time were optimized to successfully formulate the tasteless drug resin complex (DRC). The tablets were prepared using microcrystalline cellulose (MCC) PH 102 as diluent along with crospovidone (CP), croscarmellose sodium (CCM), and sodium starch glycolate (SSG) as a superdisintegrants. The tablets were evaluated for weight variation, hardness, friability, wetting time, water absorption ratio, disintegration time (DT), and dissolution study and it was concluded that the tablet formulation prepared with 2% SSG + CCS showed better disintegration time in comparison with other formulation and good drug release. The stability studies were carried out for the optimized batch for three months and it showed acceptable results.

No MeSH data available.


Related in: MedlinePlus

Experimental view of modified dissolution apparatus for disintegration test.
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fig7: Experimental view of modified dissolution apparatus for disintegration test.

Mentions: Disintegration Test Using Modified Dissolution Apparatus. Bi et al. suggested the use of a modified dissolution apparatus for disintegration (Figure 6), instead of the traditional disintegration apparatus. In this experiment, 900 mL of phosphate buffer (pH 6.8) was maintained at 37°C as the disintegration fluid and a paddle at 100 rpm as stirring element was used. Disintegration time was noted when the tablet disintegrated and passed completely through the screen of the sinker (3–3.5 mm in height and 3.5–4 mm in width, immersed at a depth of 8.5 cm from the top with the help of a hook). This method was useful in providing discrimination among batches which was not possible with the conventional disintegration apparatus (Figure 7).


Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization.

Gupta MM, Gupta N, Chauhan BS, Pandey S - J Pharm (Cairo) (2014)

Experimental view of modified dissolution apparatus for disintegration test.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4590803&req=5

fig7: Experimental view of modified dissolution apparatus for disintegration test.
Mentions: Disintegration Test Using Modified Dissolution Apparatus. Bi et al. suggested the use of a modified dissolution apparatus for disintegration (Figure 6), instead of the traditional disintegration apparatus. In this experiment, 900 mL of phosphate buffer (pH 6.8) was maintained at 37°C as the disintegration fluid and a paddle at 100 rpm as stirring element was used. Disintegration time was noted when the tablet disintegrated and passed completely through the screen of the sinker (3–3.5 mm in height and 3.5–4 mm in width, immersed at a depth of 8.5 cm from the top with the help of a hook). This method was useful in providing discrimination among batches which was not possible with the conventional disintegration apparatus (Figure 7).

Bottom Line: Among the two resins, Kyron-T-104 was selected for further studies because of high drug loading capacity, low cost, and better drug release profile.An ion exchange resin complex was prepared by the batch technique and various parameters; namely, resin activation, drug: resin ratio, pH, temperature, and stirring time, and swelling time were optimized to successfully formulate the tasteless drug resin complex (DRC).The stability studies were carried out for the optimized batch for three months and it showed acceptable results.

View Article: PubMed Central - PubMed

Affiliation: School of Pharmacy, Faculty of Medical Sciences, The University of the West Indies, St. Augustine, Trinidad and Tobago ; Department of Pharmaceutics, Jaipur College of Pharmacy, Sitapura, Tonk Road, Jaipur, Rajasthan 302022, India.

ABSTRACT
The aim of this study was to prepare fast disintegrating combination tablet of taste masked Levocetrizine dihydrochloride and Montelukast sodium by using direct compression method. To prevent bitter taste and unacceptable odour of the Levocetrizine dihydrochloride drug, the drug was taste masked with ion exchange resins like Kyron-T-104 and Tulsion-412. Among the two resins, Kyron-T-104 was selected for further studies because of high drug loading capacity, low cost, and better drug release profile. An ion exchange resin complex was prepared by the batch technique and various parameters; namely, resin activation, drug: resin ratio, pH, temperature, and stirring time, and swelling time were optimized to successfully formulate the tasteless drug resin complex (DRC). The tablets were prepared using microcrystalline cellulose (MCC) PH 102 as diluent along with crospovidone (CP), croscarmellose sodium (CCM), and sodium starch glycolate (SSG) as a superdisintegrants. The tablets were evaluated for weight variation, hardness, friability, wetting time, water absorption ratio, disintegration time (DT), and dissolution study and it was concluded that the tablet formulation prepared with 2% SSG + CCS showed better disintegration time in comparison with other formulation and good drug release. The stability studies were carried out for the optimized batch for three months and it showed acceptable results.

No MeSH data available.


Related in: MedlinePlus