Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development

2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Sivacharan Kollipara ◽  
Rajkumar Boddu ◽  
Tausif Ahmed ◽  
Siddharth Chachad
Keyword(s):  
Product Development ◽  
Generic Product ◽  
Simplified Model ◽  
Dissolution Profile ◽  
Regulatory Perspective ◽  
Model Independent

Does GastroPlus Support Similarity and Dissimilarity Factors of in vitro-in vivo Prediction in Biowaiver Studies? A Lower Strength Amlodipine As a Model Drug

Drug Research ◽  
2018 ◽  
Vol 68 (11) ◽  
pp. 625-630 ◽  
Author(s):  
Abdel Zaid ◽  
Naser Shraim ◽  
Asmaa Radwan ◽  
Nidal Jaradat ◽  
Samah Hirzallah ◽  
...  
Keyword(s):  
Health Care Professionals ◽  
In Silico ◽  
In Vitro Release ◽  
Pharmaceutical Products ◽  
Generic Product ◽  
Dissolution Profile ◽  
Market Place ◽  
Lower Strength

Abstract Background Many generic pharmaceutical products are currently available on the market place worldwide. Recently, there is a growing concern on the quality and efficacy of generic products. However, health care professionals such as physicians and pharmacists are in difficult situations to choose among alternatives. Purpose The aim of this study is to assess the effectiveness of the in silico technique (Gastro Plus®) in the biowaiver study and whether similarity and dissimilarity factors (f 2 and f 1 respectively) are effective in this regard. Method The concentration of amlodipine in the sample was calculated by comparing the absorbance of the sample with that of a previously prepared amlodipine standard solution using validated HPLC method. The dissolution profile for each product (brand and generics) was constructed. The similarity (f2) and dissimilarity (f 1) factors were calculated for the generic product according to equation 1 and 2. GastroPlus™ software (version 9.0, Simulations Plus Inc., Lancaster, CA, USA) was used to predict the absorption profiles of amlodipine from the generic product Amlovasc® and the reference Norvasc®. Conclusion These results may provide a rationale for the interchangeability between the RLD and generic version based on in vitro release profiles in silico technique especially in a lower strength dose drug.

Comparative study of different meloxicam generic products with the brand product

2019 ◽  
pp. 116-124
Keyword(s):  
Immediate Release ◽  
Generic Product ◽  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Innovator Product ◽  
Similarity Factor ◽  
Generic Products ◽  
Brand Product

This study aims to evaluate different products of meloxicam Table; Five meloxicam immediate-release generic products (15 mg Tables) were compared with the innovator, reference product, (Mobic®, Boehringer) to find the interchangeable product with the innovator product. Different physical tests were conducted including weight uniformity, thickness, diameter, hardness, friability and disintegration test. In addition, prediction of in-vivo behavior was assessed by measuring the dissolution profile of meloxicam for all the products. Similarity factor (f2) was calculated to compare between the dissolution profile of the generic products with the dissolution profile of innovator product. The results revealed that all the studied products are complied with the British Pharmacopoeia requirements. However, not all of them showed similar in-vitro profile to the brand product. Four out of five generic products, included in this study, showed similarity in dissolution profile to the brand one, which indicates possible bio-equivalency, with the advantages of money saving of using such generic products. One generic product showed similarity factor less than 50, which might give an indication that this generic product is not capable to be bioequivalent with the brand (innovator) product. Overall, this study can be considered an important applicable study that gives an indication about the in-vivo performance of different products. In addition, the study demonstrates the applicability of a simple in-vitro dissolution study as a surrogate way of assessing product bioavailability instead of an expensive and complicated in-vivo bioequivalent study.

Dissolution Profile Consideration in Pharmaceutical Product Development

2018 ◽  
pp. 287-336
Author(s):  
Disha Mehtani ◽  
Ankit Seth ◽  
Piyoosh Sharma ◽  
Rahul Maheshwari ◽  
Sara Nidal Abed ◽  
...  
Keyword(s):  
Product Development ◽  
Pharmaceutical Product ◽  
Dissolution Profile ◽  
Pharmaceutical Product Development

scholarly journals Tools for studying composite models

2021 ◽  
Author(s):  
Luca Panizzi
Keyword(s):  
Numerical Models ◽  
Higgs Sector ◽  
New Physics ◽  
Simplified Model ◽  
Phenomenological Studies ◽  
Composite Models ◽  
Numerical Tools ◽  
Model Independent ◽  
Model Approach

AbstractThis contribution provides an overview of available numerical tools for performing phenomenological studies related to the new physics predicted by composite scenarios. The overview focuses on model-independent constructions and aims at identifying the differences and connections between the implementations of numerical models, mostly focusing on the simplified-model approach. Attention is given to which kind of studies can be performed with such tools, with emphasis to the Higgs sector, new vector-like quarks and new bosonic states. A discussion of strategies for the analysis non-minimal simplified scenarios is also provided.

scholarly journals Design of Butter Spreader- An Application of Generic Product Development Process

2019 ◽  
Vol 8 (2) ◽  
pp. 6280-6284
Keyword(s):  
Product Development ◽  
New Product Development ◽  
Development Process ◽  
New Product ◽  
Generic Product ◽  
Product Development Process ◽  
Lean Product Development ◽  
Overall Design ◽  
Customer Dissatisfaction

In the current competitive scenario after globalization, product development process is a very challenging task as it depends on various factors from Customers says to Government policies. Today’s customer is technically smart and well aware about the quality of the product. Even just a word about customer dissatisfaction is sufficient to defame the brand image of the product in the market. To avoid such circumstances, it is essential to excercise scientific techniques of product development, so that manufacturers can concentrate on product quality, customer satisfaction, etc. To fulfill the requirements of the manufacturer regarding product development various approach to new product development like Lean product development, Spiral product development, agile product development have been developed by the researchers and the industrial experts. The Generic product development process is a very simple approach in the above-mentioned methodologies. This article discusses the development of butter spreader by using Generic product development process. However, in the initial phase the work is limited up to the overall design of the product.

scholarly journals Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

2019 ◽  
Author(s):  
Selass Kebede ◽  
Habtamu Abuye ◽  
Woldemichael Abraham ◽  
Sultan Suleman ◽  
Sileshi Belew
Keyword(s):  
Addis Ababa ◽  
Poor Quality ◽  
Content Uniformity ◽  
Dissolution Profile ◽  
Significant Difference ◽  
Physicochemical Evaluation ◽  
Model Independent ◽  
National Systems

AbstractThe safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines. Poor quality medicines do not meet official standards for strength, quality, purity, packaging and labelling. Hence, this study determines in-vitro quality attributes of glibenclamide 5mg tablet marketed in Addis Ababa according to USP-38 drug monograph specifications. All tested brands meet the requirements for physical inspection & complied specification for friability and hardness. Besides, the tested brands met USP 38 specification for assay (99.96% to 108.85%) and for content uniformity (AV values ranges from 3.35 to 10.04). In-vitro release tests were carried out in phosphate buffer of 7.5 and 8.5 pH and showed drug release of ≥ 75%, met USP 38 requirements. However, significant difference with respect to dissolution profile among tested brands GL4 and GL6 were confirmed with comparator product through model independent approach. Moreover, DE values were studied and confirmed that GL4 and GL6 were not therapeutically interchangeable with innovator product.

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. 

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