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In vitro - in vivo evaluation of carbamazepine conventional tablets

Karbamazepin konvansiyonel tabletlerinin in vitro in vivo incelenmesi

  1. Tez No: 102773
  2. Yazar: RİAD ELQİDRA
  3. Danışmanlar: PROF.DR. NURŞEN ÜNLÜ, PROF.DR. YILMAZ ÇAPAN
  4. Tez Türü: Yüksek Lisans
  5. Konular: Eczacılık ve Farmakoloji, Pharmacy and Pharmacology
  6. Anahtar Kelimeler: Carbamazepine, polymorphism, dissolution rate, bioavailability
  7. Yıl: 2001
  8. Dil: İngilizce
  9. Üniversite: Hacettepe Üniversitesi
  10. Enstitü: Sağlık Bilimleri Enstitüsü
  11. Ana Bilim Dalı: Farmasötik Teknoloji Ana Bilim Dalı
  12. Bilim Dalı: Belirtilmemiş.
  13. Sayfa Sayısı: Belirtilmemiş.

Özet

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Özet (Çeviri)

V ABSTRACT Elqidra, R., In Vitro-In Vivo Evaluation of Carbamazepine Conventional Tablet, Hacettepe University, Institute of Health Sciences, Thesis on Master of Degree in Pharmaceutical Technology, Ankara - Turkey, 2001. Carbamazepine (CBZ) is a widely used antiepileptic agent because of its favorable therapeutic profile. Following the oral administration, gastrointestinal absorption of CBZ is an irregular process and changes as a result of dissolution variations. CBZ is a compound which exhibits polymorphism and pseudopolymorphism. Variation in gastrointestinal absorption of CBZ is atributed the different crystalline forms of the drug in dosage forms. In the present study, four different polymorps of CBZ (a,J3,y, dihydrate) were obtained and the conventional tablets containing these crystalline forms were prepared. The effect of polymorphism on the dissolution and bioavailability of CBZ was investigated by the in vitro dissolution test and the in vivo bioavailability study. The tablets were investigated by in vitro dissolution test according to pharmacopeial recommendations. Tegretol, was selected a brand name product of CBZ to compare the in vitro - in vivo behaviour of the formulations. 3 form tablets which demonstrated the lowest dissolution rate while a and amorphous CBZ exhibited the highest dissolution rates similarly. Dissolution rates were affected significantly by different crystalline forms of CBZ. Tegretol®, amorhous bulk CBZ and |3 CBZ tablets were selected for in vivo bioavailability study. Six healthy volunteers were participated in a open- randomized cross-over designed clinical trial. After 96 h as a total blood sampling period, plasma levels of CBZ were determined by HPLC method using CN column and an acetonitrile-water (30:70) mobile phase. Pharmacokinetic parameters including the area ubder the curves (AUc o-*»), plasma peak concentrations (Cnwx) and peak times (W) were calculated. Absorption profiles of three tablets tested clinically appeared to be in accordance with their dissolution profiles. But no significant difference between (AUc a-»») and (Cmu) values was found. Only (tmax) values demonstrated a significant difference from each other.

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