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

Abstract

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 formulation, evaluation of these tablets were done such as weight variation, hardness, friability, disintegration, drug-polymer interaction, FTIR studies, SEM studies, water content, 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.  

Keywords

• Chlorpheniramine maleate,Fusion method,FTIR,SEM,Full factorial design

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

Abstract

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.  

Keywords

• Klorfeniarmin maleat,füzyon yöntemi,FTIR,SEM,Tam Faktöriyel Tasarım

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