A Simple Approach for Comparing the In Vitro Dissolution Profiles of Highly Variable Drug Products: a Proposal

2018 ◽  
Vol 20 (4) ◽  
Author(s):  
Marilyn N. Martinez ◽  
Xiongce Zhao
Keyword(s):  
Simple Approach ◽  
In Vitro Dissolution ◽  
Drug Products

scholarly journals Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products

2018 ◽  
Vol 113 ◽  
pp. 18-28 ◽  
Author(s):  
Sitaram P. Velaga ◽  
Jelena Djuris ◽  
Sandra Cvijic ◽  
Stavroula Rozou ◽  
Paola Russo ◽  
...  
Keyword(s):  
In Vitro Dissolution ◽  
Dry Powder Inhalers ◽  
Dry Powder ◽  
Drug Products

scholarly journals INFLUENCE OF DOSE AND USP DISSOLUTION APPARATUS IN THE RELEASE PERFORMANCE OF REFERENCE TABLETS: PROPRANOLOL-HCl AND RANITIDINE-HCl CASES

2019 ◽  
pp. 164-170
Author(s):  
JOSE RAUL MEDINA-LOPEZ ◽  
LUIS ANTONIO CEDILLO-DIAZ ◽  
MARCELA HURTADO
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Reference Drug ◽  
Cell Method ◽  
Drug Products ◽  
Propranolol Hcl ◽  
Flow Through ◽  
Dissolution Apparatus ◽  
Paddle Apparatus

Objective: Due to quality of generic formulations depends on available information of reference drug products the aim of this work was to perform an in vitro dissolution study of two doses of propranolol-HCl and ranitidine-HCl reference tablets using USP basket or paddle apparatus and flow-through cell method. Methods: Two doses of propranolol-HCl (10-mg and 80-mg) and ranitidine-HCl (150-mg and 300-mg) of Mexican reference products were used. Dissolution profiles of propranolol-HCl were obtained with USP basket apparatus at 100 rpm and 1000 ml of 1% hydrochloric acid. Profiles of ranitidine-HCl were determined with USP paddle apparatus at 50 rpm and 900 ml of distilled water. All formulations were also studied with the flow-through cell method using laminar flow at 16 ml/min. Dissolution profiles were compared by model-independent (f2 similarity factor, mean dissolution time and dissolution efficiency) and model-dependent methods (dissolution data adjusted to some mathematical equations). Time data, derived from these adjustments, as t50%, t63.25%, and t85% were used to compare dissolution profiles. Results: With all approaches used and being high solubility drugs significant differences were found between low and high doses and between USP dissolution apparatuses (*P<0.05). Conclusion: In vitro dissolution performance of two doses of propranolol-HCl and ranitidine-HCl was not expected. Considering the same USP dissolution apparatus, the reference tablets did not allow the simultaneous release of the used doses. The results could be of interest for pharmaceutical laboratories or health authorities that classify some drug products as a reference to be used in dissolution and bioequivalence studies.

scholarly journals Development and Validation of a Discriminating In Vitro Dissolution Method for Oral Formulations Containing Satranidazole

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Harshal Ashok Pawar ◽  
Pooja Rasiklal Joshi
Keyword(s):  
Water Solubility ◽  
Spectroscopic Method ◽  
In Vitro Dissolution ◽  
Dissolution Behavior ◽  
Solution Stability ◽  
Dissolution Medium ◽  
Drug Release Profile ◽  
Drug Products ◽  
Oral Formulations

The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to the pharmaceutical industry. Satranidazole (BCS Class II drug) is a new nitroimidazole derivative with potent antiamoebic action. There is no official dissolution medium available in the literature. In the present study, parameters such as saturation solubility in different pH medium, dissolution behavior of formulations, influence of sink conditions, stability, and discriminatory effect of dissolution testing were studied for the selection of a proper dissolution medium. Results of solubility data revealed that solubility of Satranidazole decreases with an increase in pH. Satranidazole showed better sink condition in 0.1 N HCl as compared to other media. The drug and marketed formulations were stable in the dissolution media used. An agitation speed of 75 rpm showed a more discriminating drug release profile than 50 rpm. Using optimized dissolution parameters (paddle at 75 rpm, 900 mL 0.1 N HCl) greater than 80% of the label amount is released over 60 minutes. UV-spectroscopic method used was validated for the specificity, linearity, precision, robustness, and solution stability. The method was successfully applied to granular formulations and also to marketed tablets containing 300 mg Satranidazole.

scholarly journals Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

2020 ◽  
Vol 22 (2) ◽  
Author(s):  
Robert Price ◽  
Jagdeep Shur ◽  
William Ganley ◽  
Gonçalo Farias ◽  
Nikoletta Fotaki ◽  
...  
Keyword(s):  
In Vitro Dissolution ◽  
Drug Products ◽  
Orally Inhaled Drug Products

scholarly journals Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

Pharmaceutics ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 19 ◽  
Author(s):  
Mark McAllister ◽  
Talia Flanagan ◽  
Karin Boon ◽  
Xavier Pepin ◽  
Christophe Tistaert ◽  
...  
Keyword(s):  
In Vitro Dissolution ◽  
Oral Drug ◽  
Regulatory Agencies ◽  
Pharmaceutical Sciences ◽  
Drug Products ◽  
Future Developments ◽  
In Silico Modeling ◽  
Regulatory Sciences ◽  
Key Questions

A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industrial Scientists that were involved in product development shared their experiences with in vitro dissolution and in silico modeling approaches to establish clinically relevant dissolution specifications. The regulators shared their perspectives on the acceptability of these different strategies for the development of acceptable specifications. The meeting also reviewed several collaborative initiatives that were relevant to regulatory biopharmaceutics. Following the scientific presentations, a roundtable session provided an opportunity for delegates to discuss the information that was shared during the presentations, debate key questions, and propose strategies to make progress in this critical area of regulatory biopharmaceutics. It was evident from the presentations and subsequent discussions that progress continues to be made with approaches to establish robust CRDS. Further dialogue between industry and regulatory agencies greatly assisted future developments and key areas for focused discussions on CRDS were identified.

scholarly journals Quality assessment of nine brands of metformin hydrochloride tablets marketed in Abuja, Nigeria

2021 ◽  
Vol 18 (3) ◽  
pp. 216-222
Author(s):  
Olubukola A. Odeniran1, ◽  
Olubunmi J. Olayemi ◽  
Isa H. Galadima, ◽  
Rukaiyatu A. Kirim ◽  
Christianah Y. Isimi ◽  
...  
Keyword(s):  
Active Ingredient ◽  
Type Ii Diabetes ◽  
Type Ii Diabetes Mellitus ◽  
In Vitro Dissolution ◽  
Metformin Hydrochloride ◽  
Disintegration Time ◽  
Drug Products ◽  
First Choice

Metformin is a drug of first choice in management of type II diabetes mellitus and the Nigerian market is flooded with many brands of metformin tablets. The aim of this study is to assess the pharmaceutical quality of nine brands of metformin tablets circulating in pharmacy outlets in Abuja. The brands were assessed for uniformity in weight, hardness, friability, disintegration time and in vitro dissolution using official methods. The content of active ingredient was also determined spectrophotometrically. All the brands had weights within the official limits, hardness was found to differ across the brands with values ranging between 1.20 and 11.50 kgF. Friability values were between 0.00 and 2.25%, disintegration time was between 2.06 and 10.36 min and within official specifications for film-coated tablets. Drug release within 60 min was between 93 and 103%, however, one of the brands fell outside the lower limit of the official specification and therefore, failed the dissolution test. Similarly, all but one of the brands were within the official specification of the percent content of active ingredient. The results highlight the need to routinely carry out market surveillance on drug products so as to safeguard the health of patients.

scholarly journals DISSOLUTION PERFORMANCE OF MELOXICAM FORMULATIONS UNDER HYDRODYNAMICS OF USP PADDLE APPARATUS AND FLOW-THROUGH CELL METHOD

2019 ◽  
pp. 182-188
Author(s):  
OSE RAUL MEDINA-LOPEZ ◽  
JOSE ANGEL OROZCO-JUAREZ ◽  
MARCELA HURTADO
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Weibull Function ◽  
Cell Method ◽  
Drug Products ◽  
Poorly Soluble ◽  
Flow Through ◽  
Dissolution Efficiency ◽  
Paddle Apparatus

Objective: To study the in vitro dissolution performance of four generic formulations of the poorly soluble drug meloxicam and the reference under hydrodynamic environments generated by flow-through cell method and USP paddle apparatus (pharmacopeial test). Methods: Dissolution method was validated according to ICH guidelines. Dissolution profiles were carried out with an automated flow-through cell apparatus (laminar flow at 16 ml/min with 22.6 mm cells) and USP paddle apparatus at 75 rpm. Phosphate buffer pH 7.5 at 37.0±0.5 °C was used as dissolution medium. Spectrophotometric determination of drug at 362 nm was carried out during 30 min. Dissolution profiles were compared with model-dependent and-independent methods. Results: Practically, all generic formulations showed significant differences with the percentage of drug dissolved at 30 min, mean dissolution time and dissolution efficiency, when USP paddle apparatus was used (*P<0.05), while only two generic formulations were different to reference using flow-through cell method. After adjustment to different mathematical equations, Weibull function was the best model to describe meloxicam dissolution performance and significant differences were found with all drug products when USP paddle apparatus was used, while only one formulation was different with flow-through cell method. Conclusion: The study reveals the need to look for better dissolution schemes for meloxicam tablets since USP paddle apparatus may not reflect properly the in vitro dissolution performance of meloxicam generic formulations and reference.

scholarly journals Post-marketing Assessment of Esomeprazole and Lansoprazole Enteric Coated Products Available in Saudi Arabia Based on Quality Control

2021 ◽  
pp. 94-106
Author(s):  
Doaa Hasan Alshora ◽  
Mohamed Abbas Ibrahim ◽  
Ahmed Mohammed Alomar ◽  
Tahani Nasser Alsufian
Keyword(s):  
Quality Control ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Drug Products ◽  
Relative Standard ◽  
The Us ◽  
Post Marketing ◽  
Generic Products ◽  
Enteric Coated

Introduction: Esomeprazole (ESM) and Lansoprazole (LNZ) are proton pump inhibitors, used in the treatment of peptic ulcer and gastroesophageal reflux disease. Different marketed generic products for both drugs are now available in Saudi market as enteric coated dosage form. Different factors can affect the drug release from enteric coated formulation, and therefore, the final product should be tested. Methodology: In this study three different ESM generic products (20 and 40 mg) and four LNZ generic products (15 and 30 mg) were assessed and compared to the innovator products based on quality control tests. Results: For ESM, it was found that the content uniformity results for the innovator product (Nexium®) and all other generic products lies between 85-115% with relative standard deviation (RSD) less than 6%. Also, the calculated Acceptance values (AV) was less than 15% (L1), which met the US Pharmacopeia. The in-vitro dissolution test in acid stage for Nexium® and other ESM generic products was less than 10% which met the requirement. In case of LNZ, 4 different generic enteric coated pellets filled in capsules were studied and compared to its innovator (Lanzor®), the content uniformity results showed that all products met the requirement with AV less than 15%. The in-vitro dissolution studies showed that all products met the requirement and release less than 10% of the drug in the acidic media, except LNZ-P2 containing both 15 and 30 g LNZ, which exhibited release more than 10% in the acids stage. Conclusion: post-marketing assessments for drug products play an important rule to figure out the non-effective products.

Significance of In-Vitro and In-Vivo Correlation in Drug Delivery System

2018 ◽  
Vol 4 (4) ◽  
pp. 523-531
Author(s):  
Hina Mumtaz ◽  
Muhammad Asim Farooq ◽  
Zainab Batool ◽  
Anam Ahsan ◽  
Ashikujaman Syed
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Preparations ◽  
Pharmacokinetic Profile ◽  
In Vitro Dissolution ◽  
Time Saving ◽  
Pharmaceutical Dosage Form ◽  
Short Period ◽  
Form Development

The main purpose of development pharmaceutical dosage form is to find out the in vivo and in vitro behavior of dosage form. This challenge is overcome by implementation of in-vivo and in-vitro correlation. Application of this technique is economical and time saving in dosage form development. It shortens the period of development dosage form as well as improves product quality. IVIVC reduce the experimental study on human because IVIVC involves the in vivo relevant media utilization in vitro specifications. The key goal of IVIVC is to serve as alternate for in vivo bioavailability studies and serve as justification for bio waivers. IVIVC follows the specifications and relevant quality control parameters that lead to improvement in pharmaceutical dosage form development in short period of time. Recently in-vivo in-vitro correlation (IVIVC) has found application to predict the pharmacokinetic behaviour of pharmaceutical preparations. It has emerged as a reliable tool to find the mode of absorption of several dosage forms. It is used to correlate the in-vitro dissolution with in vivo pharmacokinetic profile. IVIVC made use to predict the bioavailability of the drug of particular dosage form. IVIVC is satisfactory for the therapeutic release profile specifications of the formulation. IVIVC model has capability to predict plasma drug concentration from in vitro dissolution media.

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