Applications of Natural Polymeric Materials in Solid Oral Modified-Release Dosage Forms

2015 ◽  
Vol 21 (40) ◽  
pp. 5854-5867 ◽  
Author(s):  
Liang Li ◽  
Xin Zhang ◽  
Xiangqin Gu ◽  
Shirui Mao
Keyword(s):  
Polymeric Materials ◽  
Dosage Forms ◽  
Modified Release

Polymeric Materials and Formulation Technologies for Modified-Release Tablet Development

2009 ◽  
Vol 9 (13) ◽  
pp. 1504-1517 ◽  
Author(s):  
J. Zarate ◽  
M. Igartua ◽  
R. Hernandez ◽  
J. Pedraz
Keyword(s):  
Polymeric Materials ◽  
Modified Release ◽  
Release Tablet

In vitro and in vivo testing and correlation for oral controlled/ modified release dosage forms. report of the 2nd workshop held December 1988, Washington, DC. U.S.A.

1990 ◽  
Vol 14 (1) ◽  
pp. 95-106 ◽  
Author(s):  
Jerome P. Skelly ◽  
Gordon L. Amidon ◽  
William H. Barr ◽  
Leslie Z. Benet ◽  
James E. Carter ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Washington Dc ◽  
Modified Release ◽  
In Vivo Testing

scholarly journals Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Quantitative Composition ◽  
Modified Release ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

scholarly journals Hot-Melt 3D Extrusion for the Fabrication of Customizable Modified-Release Solid Dosage Forms

Pharmaceutics ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 738 ◽  
Author(s):  
Jaemin Lee ◽  
Chanwoo Song ◽  
Inhwan Noh ◽  
Sangbyeong Song ◽  
Yun-Seok Rhee
Keyword(s):  
Dissolution Rate ◽  
Dosage Form ◽  
Amorphous State ◽  
Dosage Forms ◽  
Modified Release ◽  
Solid Dosage Forms ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Enhanced Solubility ◽  
Hot Melt

In this work, modified-release solid dosage forms were fabricated by adjusting geometrical properties of solid dosage forms through hot-melt 3D extrusion (3D HME). Using a 3D printer with air pressure driving HME system, solid dosage forms containing ibuprofen (IBF), polyvinyl pyrrolidone (PVP), and polyethylene glycol (PEG) were printed by simultaneous HME and 3D deposition. Printed solid dosage forms were evaluated for their physicochemical properties, dissolution rates, and floatable behavior. Results revealed that IBF content in the solid dosage form could be individualized by adjusting the volume of solid dosage form. IBF was dispersed as amorphous state with enhanced solubility and dissolution rate in a polymer solid dosage form matrix. Due to absence of a disintegrant, sustained release of IBF from printed solid dosage forms was observed in phosphate buffer at pH 6.8. The dissolution rate of IBF was dependent on geometric properties of the solid dosage form. The dissolution rate of IBF could be modified by merging two different geometries into one solid dosage form. In this study, the 3D HME process showed high reproducibility and accuracy for preparing dosage forms. API dosage and release profile were found to be customizable by modifying or combining 3D modeling.

scholarly journals In-Depth Study into Polymeric Materials in Low-Density Gastroretentive Formulations

Pharmaceutics ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 636
Author(s):  
Nieves Iglesias ◽  
Elsa Galbis ◽  
Lucía Romero-Azogil ◽  
Elena Benito ◽  
Ricardo Lucas ◽  
...  
Keyword(s):  
Polymeric Materials ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Low Density ◽  
Rapid Transit ◽  
Pharmacokinetic Properties ◽  
Depth Study ◽  
Resident Time ◽  
Materials Used ◽  
Oral Dosage Forms

The extensive use of oral dosage forms for the treatment of diseases may be linked to deficient pharmacokinetic properties. In some cases the drug is barely soluble; in others, the rapid transit of the formulation through the gastrointestinal tract (GIT) makes it difficult to achieve therapeutic levels in the organism; moreover, some drugs must act locally due to a gastric pathology, but the time they remain in the stomach is short. The use of formulations capable of improving all these parameters, as well as increasing the resident time in the stomach, has been the target of numerous research works, with low-density systems being the most promising and widely explored, however, there is further scope to improve these systems. There are a vast variety of polymeric materials used in low-density gastroretentive systems and a number of methods to improve the bioavailability of the drugs. This works aims to expedite the development of breakthrough approaches by providing an in-depth understanding of the polymeric materials currently used, both natural and synthetic, their properties, advantages, and drawbacks.

Preliminary evaluation of thein vitrorelease andin vivoabsorption in rabbits of the modified-release dosage forms

2012 ◽  
Vol 39 (6) ◽  
pp. 889-900 ◽  
Author(s):  
Aleksandra A. Petrovic ◽  
Sasa M. Petricevic ◽  
Slavica M. Ristic ◽  
Svetlana R. Ibric ◽  
Slobodanka S. Simic ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Preliminary Evaluation ◽  
Modified Release

scholarly journals Report of the workshop on: in vitro and in vivo testing and correlation for oral controlled/modified release dosage forms

1990 ◽  
Vol 63 (2) ◽  
pp. 83-93 ◽  
Author(s):  
Jerome P. Skelly ◽  
Gordon L. Amidon ◽  
William H. Barr ◽  
Leslie Z. Benet ◽  
James E. Carter ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Modified Release ◽  
In Vivo Testing

scholarly journals Artificial Neural Networks in Evaluation and Optimization of Modified Release Solid Dosage Forms

Pharmaceutics ◽  
2012 ◽  
Vol 4 (4) ◽  
pp. 531-550 ◽  
Author(s):  
Svetlana Ibrić ◽  
Jelena Djuriš ◽  
Jelena Parojčić ◽  
Zorica Djurić
Keyword(s):  
Neural Networks ◽  
Artificial Neural Networks ◽  
Dosage Forms ◽  
Drug Formulation ◽  
Modified Release ◽  
Solid Dosage Forms ◽  
Important Place ◽  
Pharmaceutical Development ◽  
Solid Dosage ◽  
Artificial Neural

Implementation of the Quality by Design (QbD) approach in pharmaceutical development has compelled researchers in the pharmaceutical industry to employ Design of Experiments (DoE) as a statistical tool, in product development. Among all DoE techniques, response surface methodology (RSM) is the one most frequently used. Progress of computer science has had an impact on pharmaceutical development as well. Simultaneous with the implementation of statistical methods, machine learning tools took an important place in drug formulation. Twenty years ago, the first papers describing application of artificial neural networks in optimization of modified release products appeared. Since then, a lot of work has been done towards implementation of new techniques, especially Artificial Neural Networks (ANN) in modeling of production, drug release and drug stability of modified release solid dosage forms. The aim of this paper is to review artificial neural networks in evaluation and optimization of modified release solid dosage forms.

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