Renu Bala YADAV, Richa AHUJA, Atul Kumar SAHU, Vivek DAVE

Füzyon Yöntemiyle hazırlanan klorfeniramin maleat içeren ağızda dağılan tabletlerin formülasyonu ve değerlendirilmesi

Ticari ürün olarak klinik kullanıma sunulan birçok ilaç veriliş yolunma bağlı olarak terapötik değer kazanmaktadır. İnsanlar tablet ve kapsül gibi konvansiyonel dozaj formlarını, yolculuk gibi nedenlerle su bulamadıkları zamanlarda yutmakta zorlanmaktadırlar. Bu gibi durumlarda kullanılmak üzere ağız boşluğunda hızla dağılan tabletler dikkati çekmektedir. Ağızda dağılan tabletler, dil üzerine yerleştirildiğinde dozaj formu tükürük vasıtasıyla dağılmakta ve ilaç çözünmektedir. Katı formdaki ilaç hızla çözeltiye dönüşmekte ve bu durum ilacın emilimini ve etkinin başlamasını hızlandırmaktadır. Formülasyonlar hazırlandıktan sonra elde edilen tabletler; ortalama tablet ağırlığı ve ağırlık tekdüzeliği, sertlik, ufalanmaaşınma, dağılma zamanı, ilaç-polimer etkileşimleri, etken madde içeriği, su emme oranı, in-vitro ilaç salım özellikleri ve kısa süreli stabilite özellikleri açısından değerlendirilmiş, FTIR çalışmaları ve SeM çalışmaları yapılmıştır. F1-F10 olarak isimlendirilen tüm formülasyonların ortalama tablet ağırlığı ve ağırlık tekdüzeliği 253± 0.05 - 291± 0.61 mg, sertliği 2.1± 0.1 - 3.5± 0.07 Kg/cm², ufalanma-aşınma yüzdesi % 0.44±0.01 - 0.69±0.01, dağılma zamanı 20± 0.08 - 34±1.1 saniye, etken madde içeriği % 92.0 - 99.18, su emme oranı 26±1.12 - 49 ± 3.01, ıslanma zamanı 53± 1.89 - 104± 4.89 saniye ve 5 dakika içerisinde in-vitro ilaç salım yüzdesi % 85.66 -99.88 olarak belirlenmiştir. FTIR çalışmaları, ilaç ve polimer arasında bir etkileşim olmadığını göstermiştir. Stabilite çalışmaları ilacın farklı sıcaklık ve nem ortamında saklandığında ilaç salım özelliğinin değişmediğini göstermiştir. elde edilen sonuçlar füzyon yöntemiyle hazırlanan ve klorfeniramin maleat içeren ağızda dağılan tabletlerin hızlı dissolüsyona uğradığını göstermiştir.

Formulation and evaluation of orally dispersible tablets of Chlorpheniramine maleate by fusion method

Many conventional dosage form comes in market to achieve their therapeutic value as it administered through the given route. But sometimes People feel trouble in swallowing of conventional dosage forms like tablet and capsule without taking water or due to lack availability of water during long journey. In these cases, rapidly disintegrating tablets in oral cavity are paid attention nowadays. These are known as orally dispersible tablets which disintegrate in mouth as put on tongue resulting in release of drug which dissolve and disperse in saliva. Drug rapidly converts into solution from solid form resulting in rapid absorption and onset of action. After formulations development, evaluation of these tablets were done such as weight variation, hardness, friability, disintegration, drugpolymer interaction, FTIR studies, SeM studies, drug content, water absorption ratio, wetting time and in-vitro drug release and short term stability studies. These tablets (all formulations that is F1-F10) showed weight variation in range of 253± 0.05 to 291± 0.61 mg, hardness of 2.1± 0.1 to 3.5± 0.07 Kg/cm², friability of 0.44±0.01 to 0.69±0.01%, disintegration time of 20± 0.08 to 34±1.1 seconds, drug content of 92.0 to 99.18%, water absorption ratio of 26±1.12 to 49 ± 3.01 %, wetting time of 53± 1.89 to 104± 4.89 sec and in-vitro drug release showed 85.66 to 99.88% within 5 minutes. FTIR studies showed that there is no interaction between drug and polymer. Stability studies showed that there is no change in drug release upon storage on different temperature and humidity. Results revealed that orally dispersible tablets of chlorpheniramine maleate prepared by fusion method result in rapid dissolution.

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