scholarly journals How to Modify Drug Release in Paediatric Dosage Forms? Novel Technologies and Modern Approaches with Regard to Children’s Population

2019 ◽  
Vol 20 (13) ◽  
pp. 3200 ◽  
Author(s):  
Monika Trofimiuk ◽  
Katarzyna Wasilewska ◽  
Katarzyna Winnicka

In the pharmaceutical technology, paediatric population still presents the greatest challenge in terms of developing flexible and appropriate drug dosage forms. As for many medicines, there is a lack of paediatric dosage forms adequate for a child’s age; it is a prevailing practice to use off label formulations. Children need balanced and personalized treatment, patient-friendly preparations, as well as therapy that facilitates dosing and thus eliminates frequent drug administration, which can be ensured by modified release (MR) forms. MR formulations are commonly used in adult therapy, while rarely available for children. The aim of this article is to elucidate how to modify drug release in paediatric oral dosage forms, discuss the already accessible technologies and to introduce novel approaches of manufacturing with regard to paediatric population.

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  

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.


1997 ◽  
Vol 17 (3) ◽  
Author(s):  
A. Ainaoui ◽  
E.M. Ouriemchi ◽  
D. Bidah ◽  
M.K. El Amrani ◽  
J.M. Vergnaud

2005 ◽  
Vol 94 (1) ◽  
pp. 120-133 ◽  
Author(s):  
Thomas Schreiner ◽  
Ulrich F. Schaefer ◽  
Helmut Loth

2021 ◽  
Vol 11 (4-S) ◽  
pp. 195-211
Author(s):  
Atul Pund ◽  
Atishkumar Mundada ◽  
Manoj Magar ◽  
Abhijeet Kadam

Background: Conventional oral dosage forms have limited bioavailability and frequent dosing of the drug is needed to maintain the effective therapeutic concentration in the body. This results in poor patient compliance and fluctuations in the plasma drug levels, especially in the chronic diseases and disorders. Objective: To overcome such problems and to enhance the efficiency and bioavailability of the drug, modified drug delivery systems such as extended release delivery systems (controlled release; sustained release) and delayed release delivery systems are developed which can prolong the release and hence action of the drug in the body. Methods: Through this review, we throw the light on recent patents and patent applications on modified release systems pertaining to oral dosage forms.  The various free patent search databases were used to collect and analyze the information on modified release delivery systems. Results: Modified release systems such as extended release and delayed release delivery systems have been found to be of great significance due to their advantages over immediate release dosage forms. These systems are formulated using various approaches, different types of release controlling polymers such as natural, semisynthetic and synthetic polymers and found to avoid the limitations of conventional oral dosage forms. Conclusion: Modified drug release systems have potential especially, in case of the chronic diseases, mental health disorders and lifestyle diseases and disorders. These systems have unique commercial advantages which will sustain the interest of both the researchers and the pharmaceutical companies. Keywords: Modified release systems, extended release systems, controlled release systems, sustained release systems, delayed release systems, oral dosage forms, multilayer dosage form, multilayered tablets


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