In vitro dissolution profile comparison of an anti-migraine combinational drug in dosage form.
A novel in vitro dissolution profile was developed for formulated drug in combinational form containing naproxen sodium (NAP) and sumatriptan succinate (SUMA). This study was performed to understand the dissolution of the drug in the physiological temperature and pH. Dissolution testing was performed using USP 29 type II testing apparatus rotating at 50 r/min, in 900 mL deaerated buffer (pH 1.2, 4.5 and 6.8) which was maintained at (37 +/- 0.5) degrees C. Quantification was performed using a developed and validated high performance liquid chromatographic (HPLC) method. Aceclofenac (ACE) was used as internal standard. SUMA, ACE and NAP were eluted at 4.8, 5.7 and 7.9 min, respectively. As expected for enteric coated immediate release (IR) tablets, the dissolution of NAP and SUMA was rapid and essentially complete within 2 h using phosphate buffer (pH 6.8). The comparison of the dissolution profiles was realized by model independent approach using a difference factor (f1), similarity factor (f2) and dissolution efficiency (DE). Statistical results showed the profiles were similar to the reference and the test products. Hence, this method demonstrated to be adequate for in vitro studies of NAP and SUMA in the combinational dosage form, since there is no official monograph, collaborating to the official codes.
Hiremath
Vijay Basayya
VB
TIFAC CORE HD, JSS College of Pharmacy, Rocklands, Ooty-643001, Tamilnadu, India.
Kaliaperumal
Krishna
K
Bhojraj
Suresh
S
Nanjan
Mulla Joghee
MJ
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding; D008881:Migraine Disorders / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage / Q000493:pharmacokinetics*; D012995:Solubility; D018170:Sumatriptan / Q000008:administration & dosage / Q000493:pharmacokinetics; D013608:Tablets, Enteric-Coated; D013997:Time Factors
D013608:Tablets, Enteric-Coated; D009288:Naproxen; D018170:Sumatriptan