Development and Validation of a Discriminating In Vitro Dissolution Method for a Poorly Soluble Drug, Olmesartan Medoxomil: Comparison Between Commercial Tablets

The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium.

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Development and validation of an in vitro dissolution method for a floating dosage form with biphasic release characteristics

International Journal of Pharmaceutics ◽

10.1016/0378-5173(94)00431-4 ◽

1995 ◽

Vol 121 (1) ◽

pp. 37-44 ◽

Cited By ~ 7

Author(s):

S Burns

Keyword(s):

Dosage Form ◽

In Vitro Dissolution ◽

Dissolution Method ◽

Development And Validation ◽

Biphasic Release

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Development of a discriminating in vitro dissolution method for a poorly soluble NO-donating selective cyclooxygenase-2 inhibitor

Journal of Pharmaceutical and Biomedical Analysis ◽

10.1016/j.jpba.2007.12.025 ◽

2008 ◽

Vol 47 (1) ◽

pp. 16-22 ◽

Cited By ~ 2

Author(s):

Robert Papp ◽

Pauline Luk ◽

Wayne M. Mullett ◽

Elizabeth Kwong ◽

Smita Debnath ◽

...

Keyword(s):

Cyclooxygenase 2 ◽

In Vitro Dissolution ◽

Dissolution Method ◽

Poorly Soluble

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In vitro and in vivo Evaluation of Ibuprofen Nanosuspensions for Enhanced Oral Bioavailability

Medical Principles and Practice ◽

10.1159/000516299 ◽

2021 ◽

Author(s):

Mohsen Hedaya ◽

Farzana Bandarkar ◽

Aly Nada

Keyword(s):

Particle Size ◽

Tween 80 ◽

Aqueous Solubility ◽

In Vitro Dissolution ◽

In Vivo Evaluation ◽

Poorly Soluble ◽

Extent Of Absorption ◽

Better Than

Introduction: The objectives were to prepare, characterize and in vivo evaluate different ibuprofen (IBU) nanosuspensions prepared by ultra-homogenization, after oral administration to rabbits. Methods: The nanosuspensions produced by ultra-homogenization were tested and compared with a marketed IBU suspension for particle size, in vitro dissolution and in vivo absorption. Five groups of rabbits received orally 25 mg/kg of IBU nanosuspension, nanoparticles, unhomogenized suspension, marketed product and untreated suspension. A sixth group received 5 mg/kg IBU intravenously. Serial blood samples were obtained after IBU administration. Results: The formulated nanosuspensions showed significant decrease in particle size. Polyvinyl Pyrrolidone K30 (PP) was found to improve IBU aqueous solubility much better than the other tested polymers. Addition of Tween 80 (TW), in equal amount as PP (IBU: PP:TW, 1:2:2 w/w) resulted in much smaller particle size and better dissolution rate. The Cmax achieved were 14.8±1.64, 11.1±1.37, 9.01±0.761, 7.03±1.38 and 3.23±1.03 μg/ml and the tmax were 36±8.2, 39±8.2, 100±17.3, 112±15 and 105±17 min for the nanosuspension, nanoparticle, unhomogenized suspension, marketed IBU suspension and untreated IBU suspension in water, respectively. Bioavailability of the different formulations relative to the marketed suspension were the highest for nanosuspension> unhomogenized suspension> nanoparticles> untreated IBU suspension. Conclusion: IBU/PP/TW nanosuspensions showed enhanced in vitro dissolution as well as faster rate and higher extent of absorption as indicated from the higher Cmax, shorter tmax and larger AUC. The in vivo data supported the in vitro results. Nanosuspensions prepared by ultra-high-pressure-homogenization technique can be used as a good formulation strategy to enhance the rate and extent of absorption of poorly soluble drugs.

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