scholarly journals IN VITRO EQUIVALENCE STUDY OF DIFFERENT DOSES OF CARBAMAZEPINE REFERENCE TABLETS USING USP APPARATUSES 2 AND 4

2019 ◽  
pp. 291-295
Author(s):  
JOSE RAUL MEDINA-LOPEZ ◽  
Luis Antonio Cedillo-Díaz ◽  
Marcela Hurtado
Keyword(s):  
High Dose ◽  
Local Market ◽  
Dissolution Medium ◽  
Usp 4 ◽  
Usp Apparatus 4 ◽  
Dissolution Apparatus ◽  
Usp Apparatus ◽  
Usp Apparatus 2

Objective: To perform an in vitro equivalence study of two doses of carbamazepine reference tablets sold in the local market under hydrodynamic conditions of USP Apparatus 4, a dissolution apparatus that better simulates the human gastrointestinal tract. Results were compared with dissolution official conditions using USP Apparatus 2. Methods: Dissolution profiles of both formulations were carried out with an automated USP Apparatus 2 at 75 rpm and 900 ml of dissolution medium. USP Apparatus 4 with laminar flow at 16 ml/min and 22.6 mm cells were used. 1% lauryl sulfate aqueous solution at 37.0±0.5 °C was used as dissolution medium. Spectrophotometric determination of drug at 285 nm was carried out during 60 min. Dissolution profiles were compared with model-independent and-dependent approaches. Results: When comparing dissolution profiles of low vs. high dose similar profiles were found (f2>50) in each dissolution apparatus, however, when the same dose was compared, USP 2 vs. USP 4, opposite results were obtained. Comparison of mean dissolution time and dissolution efficiency data corroborates these results. Weibull function was the best mathematical model that described the in vitro dissolution performance of carbamazepine. No significant differences were found in Td values (low vs. high dose) but opposite results were also found with USP 2 vs. USP 4. Conclusion: Equivalent dissolution performance of two doses of carbamazepine reference tablets were found in each USP dissolution apparatus. The main problem identified in this comparative study is the low dissolution rate and extent found with USP Apparatus 4. More research on this field is necessary for all available doses of reference drug products since the quality of generic formulations depends on the quality of references.

scholarly journals COMPARISON OF THE USP APPARATUS 2 AND 4 FOR TESTING THE IN VITRO RELEASE PERFORMANCE OF IBUPROFEN GENERIC SUSPENSIONS

2017 ◽  
Vol 9 (4) ◽  
pp. 90 ◽  
Author(s):  
Jose Raul Medina ◽  
Mariel Cortes ◽  
Erik Romo
Keyword(s):  
In Vitro Release ◽  
Generic Product ◽  
Dissolution Profile ◽  
Drug Products ◽  
Flow Through ◽  
Usp Apparatus 4 ◽  
Usp Apparatus ◽  
Usp Apparatus 2 ◽  
Vitro Release

Objective: The aim of this study was the comparison of the in vitro release performance of ibuprofen generic suspensions and reference, based on the hydrodynamic environment generated by the flow-through cell method (USP Apparatus 4). Results were compared with those obtained by the use of the USP Apparatus 2.Methods: The Advil® suspension (2 g/100 ml) and two generic formulations with the same dose were tested. Dissolution studies were carried out using a USP Apparatus 4 Sotax CE6 with 22.6 mm cells, laminar flow at 16 ml/min, and pH 7.2 phosphate buffer at 37.0±0.5 °C as dissolution medium. Ibuprofen was quantified spectrophotometrically at 222 nm. The in vitro release of the three drug products were studied using the USP Apparatus 2. The dissolution profiles of generic products were compared with the reference by model-independent, model-dependent, and analysis of variance (ANOVA)-based comparisons.Results: The dissolution profile of the generic product A was similar to the dissolution profile of reference, only with the use of the USP Apparatus 4. The f2 similarity factor was>50 and no significant differences were found with dissolution efficiency data (*P>0.05). Similar results were found with the comparison of t50% and t63.2% values. Similar dissolution profiles between generic product A and reference were also found with ANOVA-based comparisons.Conclusion: The flow-through cell method was adequate for study the in vitro release of ibuprofen suspensions. It is necessary to evaluate the in vivoperformance of the drug products used in order to estimate the predictability of the proposed methodology. 

scholarly journals Dissolution Test for Mianserin Hydrochloride in Tablets

2019 ◽  
Vol 3 (2) ◽  
pp. 18-22
Author(s):  
Letícia Lenz Sfair ◽  
Caren Gobetti ◽  
Martin Steppe ◽  
Elfrides Schapoval
Keyword(s):  
Drug Release ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Dissolution Medium ◽  
Drug Release Profile ◽  
Dissolution Tests ◽  
Usp Apparatus ◽  
Usp Apparatus 2

A dissolution test for mianserin hydrochloride in coated tablets containing 30 mg was developed and validated using a fast ultraviolet spectrophotometric method. The appropriate conditions were determinate after testing sink conditions, agitation spped and dissolution medium. The sink conditions tested showed that mianserin hydrochloride was soluble in 0.01 and 0.1 M hydrochloric acid (HCl), acetate buffer pH 4.1 and 5.0 and phosphate buffer pH 6.8. Then, dissolution tests were performed to investigate the drug release in each medium. Optimal conditions to carry out the dissolution test were 900 mL 0.1 M HCl and USP apparatus 2 (paddle) at 50 rpm stirring speed. The quantification method was also adapted and validated. The UV method showed specificity, linearity, precision and accuracy. The in vitro dissolution test can be used to evaluate the drug release profile and the data was used as an aid to establish a possible correlation with in vivo data.

scholarly journals Comparative in vitro dissolution studies of fixed-dose combination formulations: analgesic tablets of acetaminophen/caffeine

2021 ◽  
Vol 12 (2) ◽  
pp. 1063-1073
Author(s):  
Medina-López J R ◽  
Sánchez-Badajos S ◽  
Carreto-Jiménez R M ◽  
García-Hernández P ◽  
Contreras-Jiménez J M
Keyword(s):  
Fixed Dose Combination ◽  
In Vitro Dissolution ◽  
Fixed Dose ◽  
Dissolution Studies ◽  
Derivative Method ◽  
Dose Combination ◽  
Usp Apparatus ◽  
Usp Apparatus 2

A simple and rapid UV derivative method with zero-crossing determinations was developed for estimation of acetaminophen (ACE) and caffeine (CAF) in fixed-dose combination formulations. The first-derivative of standard solutions of both drugs were used and ACE and CAF were quantified at 273.0 and 216.5 nm, respectively. The method was validated, and it was applied to dissolution studies with the USP Apparatus 2 and flow-through cell (USP Apparatus 4). Dissolution profiles comparisons (generic vs reference) were carried out with model-independent and model-dependent approaches. Mean dissolution time and dissolution efficiency were calculated and significant differences, in almost all calculated parameters, were found (p<0.05). Weibull, logistic, Gompertz, and Probit models were used to fit dissolution data and Probit was the best-fit model that describes the in vitro dissolution performance of ACE and CAF. Using t50% data, derived from this fit, dissolution profiles of ACE in USP Apparatus 2 were significant different (p<0.05). The proposed UV derivative method generates reliable information that can be compared with published results. Dissolution studies of fixed-dose combination formulations are important because quality of generic drug products depends on quality of references. It is essential to maintain a post-marketing evaluation of formulations with analgesic drugs mixed with CAF to offer the population high quality medicines.

Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal® Consta®

2011 ◽  
Vol 420 (2) ◽  
pp. 198-205 ◽  
Author(s):  
Archana Rawat ◽  
Erika Stippler ◽  
Vinod P. Shah ◽  
Diane J. Burgess
Keyword(s):  
In Vitro Release ◽  
Usp Apparatus 4 ◽  
Usp Apparatus ◽  
Vitro Release ◽  
Release Testing

USP Apparatus 4: a Valuable In Vitro Tool to Enable Formulation Development of Long-Acting Parenteral (LAP) Nanosuspension Formulations of Poorly Water-Soluble Compounds

2017 ◽  
Vol 19 (1) ◽  
pp. 413-424 ◽  
Author(s):  
William P. Forrest ◽  
Kevin G. Reuter ◽  
Vivek Shah ◽  
Irina Kazakevich ◽  
Michael Heslinga ◽  
...  
Keyword(s):  
Water Soluble ◽  
Formulation Development ◽  
Usp Apparatus 4 ◽  
Poorly Water Soluble ◽  
Long Acting ◽  
Usp Apparatus

scholarly journals Comparison of Generic Furosemide Products by In Vitro Release Studies using USP Apparatus 2 and 4

2021 ◽  
Vol 28 (1) ◽  
pp. 14-22
Author(s):  
José Raúl Medina-López ◽  
Alexander Domínguez-Reyes ◽  
Marcela Hurtado
Keyword(s):  
In Vitro Release ◽  
Release Studies ◽  
Usp Apparatus ◽  
Usp Apparatus 2 ◽  
Vitro Release

scholarly journals Development and Study of Semi-Solid Preparations Containing the Model Substance Corticotropin (ACTH): Convenience Application in Neurodegenerative Diseases

Molecules ◽  
2020 ◽  
Vol 25 (8) ◽  
pp. 1824
Author(s):  
Wioletta Siemiradzka ◽  
Barbara Dolińska ◽  
Florian Ryszka
Keyword(s):  
Lupus Erythematosus ◽  
Chemical Parameters ◽  
High Concentration ◽  
In Vitro Drug Release ◽  
Model Substance ◽  
Semi Solid ◽  
Usp Apparatus ◽  
Physical And Chemical ◽  
Usp Apparatus 2

Corticotropin (ACTH, previously an adrenocorticotropic hormone) is used in the diagnosis and treatment of pituitary gland disorders, adrenal cortex disorders, and other diseases, including autoimmune polymyositis, systemic lupus erythematosus, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. So far, the ointment dosage form containing ACTH for use on the skin is unknown. Therefore, it seems appropriate to develop a semi-solid formulation with corticotropin. Emulsion ointments were prepared using an Unguator based on the cream base Lekobaza® containing corticotropin in different concentrations, and then the physical and chemical parameters of the ointment formulations, such as pH, spreadability, rheological properties, and texture analysis, were evaluated. In addition, a USP apparatus 2 with enhancer cells was utilized to study the in vitro drug release characteristics of the selected formulations. All the ointments obtained were characterized by good spreadability and viscosity. An analysis of the ointment texture was performed and the dependence of the tested parameters on the ACTH content in the ointment was demonstrated. Examination of the structure of the ointment showed that a high concentration of ACTH increases the hardness and adhesiveness of the ointment. In turn, it adversely affects the cohesiveness and elasticity of the ointments tested. The results of the release study showed that ACTH is released the fastest from the formulation with the lowest concentration, while the slowest from the ointment with the highest concentration of ACTH.

scholarly journals Formulation and In vitro Evaluation of Oral Floating Tablets of Salbutamol Sulphate: Comparison with Effervescent Tablets

2017 ◽  
Vol 15 (2) ◽  
pp. 203-208
Author(s):  
Md Haider Ali ◽  
Mohiuddin Ahmed Bhuiyan ◽  
Md Selim Reza ◽  
Samira Karim
Keyword(s):  
Drug Release ◽  
Oral Delivery ◽  
Dosage Form ◽  
In Vitro Dissolution ◽  
Salbutamol Sulphate ◽  
Floating Tablets ◽  
Gastric Residence Time ◽  
Usp Apparatus ◽  
Usp Apparatus 2

The aim of this research was to develop and evaluate gastric floating tablets of salbutamol sulphate. The oral delivery of anti-asthmatic salbutamol sulphate tablets were facilitated by preparing floating dosage form which could increase its absorption in the stomach by increasing the gastric residence time of the drug. Floating tablets were formulated by using different polymers like carbopol, xanthan gum, HPMC-K4 MCR and HPMC- K100 MCR with different proportions. A comparative study of normal effervescent tablets of salbutamol sulphate had also been done. The prepared tablets were evaluated for all their physicochemical properties and in vitro buoyancy study. In vitro dissolution studies of the formulations were done in pH 6.8 phosphate buffer using USP apparatus 2 (paddle method) at 50 rpm. Percent drug release of the formulations (F-1 to F-11) was from 87.34%- 99.12% after 12 hours. From the results, F-11 was selected as an optimized formulation based on 12 h drug release which showed minimal floating lag time and maximum floating time. On the other hand, 100% drug was released within 2 hours from the F-12 of effervescent salbutamol sulphate tablets in which polymer was absent while gas generating sodium bicarbonate and citric acid were present. The results of the study were consistent and may encourage formulating similar dosage form with other drugs.Dhaka Univ. J. Pharm. Sci. 15(2): 203-208, 2016 (December)

scholarly journals Release Modification of Indomethacin Controlled Release Press Coated Tablets

2016 ◽  
Vol 19 (2) ◽  
pp. 219-225 ◽  
Author(s):  
Muhammad Rashedul Islam ◽  
Md Elias Al Mamun ◽  
Md Mizanur Rahman Moghal
Keyword(s):  
Drug Release ◽  
Pharmaceutical Journal ◽  
In Vitro Dissolution ◽  
Compression Pressure ◽  
Pressure Formulation ◽  
Release Data ◽  
Usp Apparatus ◽  
Usp Apparatus 2 ◽  
Core Tablet

The study was carried out to evaluate the release modification of indomethacin press coated tablets through different polymers. Several batches of press coated tablets were prepared with indomethacin and Avicel PH 102. The core tablet was compression coated with minimal compression pressure. Formulation IX was modified by incorporating PEG 6000, sodium chloride and sodium lauryl sulphate (SLS). In vitro dissolution studies of the formulations of different excipients were done at pH 7.2 in phosphate buffer using USP apparatus 2 (paddle method) at 50 rpm and 37 ± 0.5 °C temperature. The drug release data was treated in different mathematical fashion to identify the kinetic behaviour. It was found that, drug release which was inversely proportional to the amount of xanthan gum in the coating formulations was significantly changed by the polymers used in the study. Incorporation of SLS caused the drug to be released in near zero order fashion. Drug release was found to follow Higuchi mechanism for all the formulations. The study reveals that the polymers used may be a significant factor for the discrepancy in release rate of indomethacin.Bangladesh Pharmaceutical Journal 19(2): 219-225, 2016

scholarly journals Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2

2006 ◽  
Vol 13 (3) ◽  
pp. 15-18 ◽  
Author(s):  
Pallavi Nithyanandan ◽  
Gang Deng ◽  
William Brown ◽  
Ronald Manning ◽  
Samir Wahab
Keyword(s):  
Dissolved Gas ◽  
Dissolution Medium ◽  
Usp Apparatus ◽  
Usp Apparatus 2
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