scholarly journals Safe use of Dexamethasone in pediatrics: design and evaluation of a novel stable oral suspension

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Ana Santoveña-Estévez ◽  
Diego Dorta-Vera ◽  
Iris González-García ◽  
Javier Suárez-González ◽  
Nuria Teigell-Pérez ◽  
...  
Keyword(s):  
Quality Criteria ◽  
Standard Operating Procedure ◽  
Active Pharmaceutical Ingredient ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Citrate Buffer ◽  
Physical Chemical ◽  
Oral Formulations ◽  
Minimum Number ◽  
And Control

Abstract Background Dexamethasone is used in pediatrics mainly for treatment of croup and bronchopulmonary dysplasia. Commercially available pediatric oral formulations include inadequate excipients for this population. When there are only commercially available oral dosage forms for adults, a formulation is prepared to reduce the dose by manipulation of authorized tablets or injectable dosage forms. This practice most of times is made without the quality and control that process requires. The aim of this study is to propose a formulation secure and suitable for pediatrics by the use of a Standard Operating Procedure that ensures its quality. Methods Design of two formulations was performed with lowest number and amount of excipients suitable for pediatrics, avoiding use of dexamethasone salts and preservatives. An accurate and precise analytical method and a methodology for analyzing uniformity of doses were developed. Physical, chemical and microbiological stability was tested. Results Stability of Dexamethasone was improved by acidification with citric/citrate buffer. Proposed suspension complies with quality criteria required for an oral non-sterile formulation using Dexamethasone as active pharmaceutical ingredient, and the minimum number and quantity of excipients suitable for pediatrics. Conclusions This formulation is physical, chemical and microbiologically stable during 15 days storage at 5 and 25°C.

scholarly journals Application of Permeation Enhancers in Oral Delivery of Macromolecules: An Update

Pharmaceutics ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. 41 ◽  
Author(s):  
Sam Maher ◽  
David Brayden ◽  
Luca Casettari ◽  
Lisbeth Illum
Keyword(s):  
Oral Delivery ◽  
State Of The Art ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Active Pharmaceutical Ingredients ◽  
Permeation Enhancers ◽  
Pharmaceutical Ingredients ◽  
Current State ◽  
Oral Formulations ◽  
Oral Dosage Forms

The application of permeation enhancers (PEs) to improve transport of poorly absorbed active pharmaceutical ingredients across the intestinal epithelium is a widely tested approach. Several hundred compounds have been shown to alter the epithelial barrier, and although the research emphasis has broadened to encompass a role for nanoparticle approaches, PEs represent a key constituent of conventional oral formulations that have progressed to clinical testing. In this review, we highlight promising PEs in early development, summarize the current state of the art, and highlight challenges to the translation of PE-based delivery systems into safe and effective oral dosage forms for patients.

Patent landscape of pediatric-friendly oral dosage forms and administration devices

2021 ◽  
pp. 1-23
Author(s):  
Christina Karavasili ◽  
Angelos Gkaragkounis ◽  
Dimitrios G. Fatouros
Keyword(s):  
Dosage Forms ◽  
Oral Dosage ◽  
Patent Landscape ◽  
Oral Dosage Forms

scholarly journals Multi-Analytical Framework to Assess the In Vitro Swallowability of Solid Oral Dosage Forms Targeting Patient Acceptability and Adherence

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 411
Author(s):  
Abdul Latif Ershad ◽  
Ali Rajabi-Siahboomi ◽  
Shahrzad Missaghi ◽  
Daniel Kirby ◽  
Afzal Rahman Mohammed
Keyword(s):  
Hydroxypropyl Methylcellulose ◽  
Analytical Framework ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Surface Erosion ◽  
World Population ◽  
Swallowing Problems ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

A lack of effective intervention in addressing patient non-adherence and the acceptability of solid oral dosage forms combined with the clinical consequences of swallowing problems in an ageing world population highlight the need for developing methods to study the swallowability of tablets. Due to the absence of suitable techniques, this study developed various in vitro analytical tools to assess physical properties governing the swallowing process of tablets by mimicking static and dynamic stages of time-independent oral transitioning events. Non-anatomical models with oral mucosa-mimicking surfaces were developed to assess the swallowability of tablets; an SLA 3D printed in vitro oral apparatus derived the coefficient of sliding friction and a friction sledge for a modified tensometer measured the shear adhesion profile. Film coat hydration and in vitro wettability was evaluated using a high-speed recording camera that provided quantitative measurements of micro-thickness changes, simulating static in vivo tablet–mucosa oral processing stages with artificial saliva. In order to ascertain the discriminatory power and validate the multianalytical framework, a range of commonly available tablet coating solutions and new compositions developed in our lab were comparatively evaluated according to a quantitative swallowability index that describes the mathematical relationship between the critical physical forces governing swallowability. This study showed that the absence of a film coat significantly impeded the ease of tablet gliding properties and formed chalky residues caused by immediate tablet surface erosion. Novel gelatin- and λ-carrageenan-based film coats exhibited an enhanced lubricity, lesser resistance to tangential motion, and reduced stickiness than polyvinyl alcohol (PVA)–PEG graft copolymer, hydroxypropyl methylcellulose (HPMC), and PVA-coated tablets; however, Opadry® EZ possessed the lowest friction–adhesion profile at 1.53 a.u., with the lowest work of adhesion profile at 1.28 J/mm2. For the first time, the in vitro analytical framework in this study provides a fast, cost-effective, and repeatable swallowability ranking method to screen the in vitro swallowability of solid oral medicines in an effort to aid formulators and the pharmaceutical industry to develop easy-to-swallow formulations.

scholarly journals Formulation Effects in the Antioxidant Activity of Extract from the Leaves of Cymbopogon citratus (DC) Stapf

Molecules ◽  
2021 ◽  
Vol 26 (15) ◽  
pp. 4518
Author(s):  
Raquel Sousa ◽  
Artur Figueirinha ◽  
Maria Teresa Batista ◽  
Maria Eugénia Pina
Keyword(s):  
Antioxidant Activity ◽  
Perennial Grass ◽  
Antioxidant Properties ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Dpph Assay ◽  
Cymbopogon Citratus ◽  
The World ◽  
Food And Beverage ◽  
Oral Dosage Forms

Cymbopogon citratus DC (Stapf.) is a perennial grass and it is distributed around the world. It is used as a condiment for food and beverage flavouring in the form of infusions and decoctions of its dried leaves. Our previous studies have shown antioxidant, anti-inflammatory and gastroprotective activities for the infusion and its phenolic fractions. The aim of the present work was to develop oral dosage forms from a Cymbopogon citratus extract to be used as a functional food with antioxidant properties. Initially, an essential oil-free infusion was prepared, lyophilized and characterized by HPLC-PDA. Total phenols were quantified with the Folin–Ciocalteu method and the antioxidant activity was assessed by DPPH assay. Gelatine capsules containing the extract with different excipients, selected after DSC and IR trials, were prepared. A formulation exhibiting better antioxidant behaviour in a gastric environment was attained. These results suggest that the proposed formulation for this extract could be a valuable antioxidant product and, consequently, make an important contribution to “preventing” and minimizing diseases related to oxidative stress conditions.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam

2014 ◽  
Vol 103 (2) ◽  
pp. 367-377 ◽  
Author(s):  
Igor E. Shohin ◽  
Julia I. Kulinich ◽  
Galina V. Ramenskaya ◽  
Bertil Abrahamsson ◽  
Sabine Kopp ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Quinine Sulfate

2012 ◽  
Vol 101 (2) ◽  
pp. 499-508 ◽  
Author(s):  
Stefanie Strauch ◽  
Jennifer B. Dressman ◽  
Vinod P. Shah ◽  
Sabine Kopp ◽  
James E. Polli ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Quinine Sulfate ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms
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