Large Sample Tests for Binary Outcomes in Fixed-Dose Combination Drug Studies

Biometrics ◽  
1997 ◽  
Vol 53 (2) ◽  
pp. 498 ◽  
Author(s):  
Sue-Jane Wang ◽  
H. M. James Hung
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Binary Outcomes ◽  
Combination Drug ◽  
Large Sample ◽  
Dose Combination ◽  
Drug Studies

scholarly journals Simultaneous Quantification of Acetaminophen, Caffeine, and Ibuprofen in Fixed Dose Combination Drug Using HPLC with UV Detection

2019 ◽  
pp. 1-19
Author(s):  
Emmanuel K. Darkwah ◽  
Christopher K. Acquah ◽  
Paul S. Lambon ◽  
David K. Ameko ◽  
Omotayo Akanji ◽  
...  
Keyword(s):  
Internal Standard ◽  
Uv Detection ◽  
Fixed Dose Combination ◽  
World Health ◽  
Fixed Dose ◽  
Good Resolution ◽  
Combination Drug ◽  
Simultaneous Quantification ◽  
Combination Drugs ◽  
Dose Combination

Combination therapy of analgesics is well suited for pain management especially in elderly patients and, has been recommended by the World Health Organization (WHO). Drug analysis plays an important role in the development, manufacture and therapeutic use of drug. In this study, a suitable, cost effective Isocratic HPLC-UV method (Reversed Phase) has been developed and validated for the simultaneous quantification of Acetaminophen, Caffeine, and Ibuprofen in fixed dose combination drugs, using a mobile phase combination of methanol and 0.025M Phosphate buffer –(adjusted to pH 3.2 with Orthophosphoric acid) in the ratio 85:15.A Vertex Column-Eurospher C18 (250 x 4.6 mm), flow rate of 1.0 ml/min at 25°C were the chromatographic conditions. With Piroxicam as internal standard, quantification was achieved with UV detection at 225 nm based on the peak area responses. A good resolution and a short run time (7mins) were achieved with the validated conditions. In consequence, statistical evaluation at the 95% confidence limits revealed that, the method was Linear; with an average correlation coefficient (R = 0.995), and accurate - (mean recovery 99.45% for Acetaminophen, 100.10% for Caffeine and 99.28% for Ibuprofen). With an instrument and intermediate precision RSDs>2.0, the method was found to be specific, Robust, and more economical. Six formulated combination products on the Ghana market were assayed using the validated method. The Acetaminophen, Caffeine and Ibuprofen contents in the combination drugs varied from 97.35% to 103.88%.

Cocrystals of zonisamide: physicochemical characterization and sustained release solid forms

CrystEngComm ◽  
2018 ◽  
Vol 20 (21) ◽  
pp. 2923-2931 ◽  
Author(s):  
Srinivasulu Aitipamula ◽  
Joseph Cadden ◽  
Pui Shan Chow
Keyword(s):  
Sustained Release ◽  
Physicochemical Characterization ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Drug ◽  
Dose Combination ◽  
Treatment Of Obesity ◽  
Obesity Drugs

A multi-API cocrystal containing two anti-obesity drugs, zonisamide and caffeine, was found to be promising for the development of a sustained release fixed-dose combination drug for the treatment of obesity.

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