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G.ACHAIAH2
Nalanda college of pharmacy, Osmania University, Nalgonda, India. University College of Pharmaceutical Sciences, Kakatiya University, Warangal, India.
*Corresponding author
goje_arjun@yahoo.com
ABSTRACT
To improve patient compliance, mouth dissolving tablets have emerged as an alternative to conventional dosage forms. Rosiglitazone and Sulfonylurea are given in combination for treatment of type 2 Diabetes Mellitus for long term therapy. During this therapy, it is observed that there is uncontrolled increase of blood glucose level. Therefore, mouth dissolving tablets of Rosiglitazone were prepared to overcome this unusual problem and to make use of the inherent advantages of the novel drug delivery system. Rosiglitazone with Sodium Starch Glycolate, Cross povidone & Cross carmellose sodium were tableted with a view to obtain mouth dissolving tablets. Rosiglitazone mouth dissolving tablets containing Cross povidone & Cross carmellose sodium in the ratio 1:1 showed maximum drug release. Formulations were subjected to stability studies. Formulations are stable for 4 weeks at 40 oC / 75 % RH with insignificant change in the hardness, disintegration time and in vitro drug release pattern.
KEY WORDS
Mouth dissolving tablets, sodium starch glycolate, Crosscarmellose sodium, Crospovidone.
INTRODUCTION
Oral route of drug administration have wide acceptance, up to 50-60% of solid dosage forms are popular because of natural, uncomplicated, convenient, ease of administration, accurate dosage, self medication, pain avoidance and most importantly patient compliance. The most popular solid dosage forms being tablets and 1 www.ijpbs.net
capsules, one important drawback of these dosage forms for patient is the difficulty to swallow. Swallowing of solid dosage forms like tablets and capsules and improper dosing of suspension and emulsion may produce difficulty for young children because of incomplete development of muscular and nervous system and elderly patients suffering from dysphasia, Parkinsons disorder and tremor. Other Pharmaceutics
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Composition of Mouth Dissolving Tablets of Rosiglitazone. Formulation Nos. F1 4 2 71.5 20 1 1 0.5 3 www.ijpbs.net Pharmaceutics F2 4 2 71.5 20 1 1 0.5 F3 4 2 71.5 20 1 1 0.5 F4 4 1 1 71.5 20 1 1 0.5 F5 4 1 1 71.5 20 1 1 0.5 F6 4 1 1 71.5 20 1 1 0.5
Ingredients (mgs) Rosiglitazone Sodium Starch Glycolate Cross povidone Cross carmellose sodium Microcrystalline cellulose Lactose Magnesium Stearate Talc Aspartame
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12 cm
Tissue Paper
Figure 1
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Cumulative % drug Released of Rosiglitazone from Formulation F1 to F6. Time in Min 2 4 6 8 10 12 F1 32.853 53.401 66.846 78.997 97.801 99.497 F2 54.857 63.766 74.862 84.691 95.356 99.385 F3 38.644 63.76 73.717 88.108 96.669 98.371 F4 54.857 79.890 86.315 97.218 F5 60.648 78.738 88.605 99.496 F6 38.644 45.339 73.717 88.108 94.404 97.246
The cumulative percentage of Rosiglitazone released as a function of time (t) for formulations F1 to F6 are shown in Figure 2. 6 www.ijpbs.net Pharmaceutics
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Figure 2 Cumulative % Drug Released v/s Time of Formulation F1 to F6. Formulation F1, F2, F3 F4, F5 and F6 prepared by direct compression method was found to release 99.50 %, 99.39 %, 98.37 %, 97.22 %, 99.50 % and 97.25 % respectively, at end of 12 minutes. This rapid dissolution might be due to fast breakdown of particles of superdisintegrants and porous structure of the tablet. In all formulations the drug release was nearer to 100 % within 12 minutes. F1 and F5 showed good drug release than other formulations. The formulations F4, F5 were selected for stability studies on the basis of their high cumulative % drug release and also results of in vitro disintegration time, wetting time, and in vivo disintegration time. The stability studies were carried out at 25 oC / 60 % RH and 40 oC / 75 % RH for all the selected formulations up to 30 days. For every 10 days time interval the tablets were analyzed for drug content uniformity, hardness, in vitro disintegration time, friability and wetting time up to 30 days. These formulations showed not much variation in any 7 www.ijpbs.net Pharmaceutics parameter. From these results it was concluded that, formulations F4 & F5 are stable and retained their original properties.
CONCLUSION
From the experimental results it can be concluded that the mouth dissolving system can be formulated using different superdisintegrants like Sodium Starch Glycolate, Crosspovidone, Cross Carmellose Sodium by Direct Compression technique.
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ACKNOWLEDGEMENT
The authors are thankful to Sun pharma (India), Bombay for providing Rosiglitazone as a gift sample and to Dr.David banji, Principal, Nalanda College of Pharmacy for providing all the necessary facilities to carry out the work.
REFE REFERENCES
1. Indurwade NH., Rajyaguru TH., Nakhat PD, Novel approach-fast dissolving tablets. Indian drugs,39(8):405-7,(2002).
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