scholarly journals In Vivo Antimalarial Activity of Polyalthia longifolia (Annonaceae) Leaf Extract and Assessment of Its Formulated Oral Dosage Forms

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Samuel Korsah ◽  
Stephen Yao Gbedema ◽  
Marcel Tunkungmen Bayor ◽  
Mariam El Boakye-Gyasi ◽  
Frederick William Akuffo Owusu ◽  
...  
Keyword(s):  
Antimalarial Activity ◽  
Dosage Forms ◽  
Stability Study ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Hematological Indices ◽  
Oral Dosage Forms ◽  
Polyalthia Longifolia

Plant medicine is commonly employed to treat malaria and other infections in Ghana. However, many of these phytomedicines have not been scientifically investigated to justify their use. This study therefore sought to investigate the antimalarial property of Polyalthia longifolia leaves and to formulate suitable dosage forms for ease of administration. A four-day antiplasmodial suppressive and curative study was conducted on ethanol extract of P. longifolia leaves (PLE) using Plasmodium berghei infected albino mice. Tablet and suspension dosage forms of PLE were formulated and evaluated for quality and stability. Statistically significant ( P < 0.05 ) parasitaemia suppression (61.25%) and cure (58.78%) were achieved at a PLE dose of 100 mg/kg, and increases in hematological indices ( P < 0.001 ) were also observed in the PLE-treated mice as compared to the untreated group. The tablets passed the tests for uniformity of weight, friability (<1%), hardness, disintegration (<15 minutes), and in vitro dissolution (>70% release in 45 minutes). The sedimentation volume, rheology, viscosity, and pH of the formulated suspension were within the official specifications. The dosage forms showed consistency in PLE content (85–105%) and no changes in physicochemical properties over the six months period of stability study. The in vivo antimalarial activity of PLE has been established and oral dosage forms that conformed to Pharmacopoeial standards are formulated for use in the management of malaria.

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 FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

1997 ◽  
Vol 4 (4) ◽  
pp. 23-32 ◽  
Author(s):  
Henry Malinowski ◽  
Patrick Marroum ◽  
Venkata Ramana Uppoor ◽  
William Gillespie ◽  
Hae-Young Ahn ◽  
...  
Keyword(s):  
Extended Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Fda Guidance ◽  
Solid Oral Dosage Forms ◽  
Development Evaluation ◽  
Oral Dosage Forms

scholarly journals Tailored on demand anti-coagulant dosing: An in vitro and in vivo evaluation of 3D printed purpose-designed oral dosage forms

2018 ◽  
Vol 128 ◽  
pp. 282-289 ◽  
Author(s):  
Basel Arafat ◽  
Nidal Qinna ◽  
Milena Cieszynska ◽  
Robert T. Forbes ◽  
Mohamed A. Alhnan
Keyword(s):  
Dosage Forms ◽  
Oral Dosage ◽  
In Vivo Evaluation ◽  
On Demand ◽  
3D Printed ◽  
Oral Dosage Forms

scholarly journals Effect of Medium pH on In Vitro Dissolution of Marketed Tetracyclines (Tetracycline and Doxycycline) Solid Oral Dosage Forms in Bahia, Brazil

2020 ◽  
Vol 27 (2) ◽  
pp. 32-40
Author(s):  
João Luis S. de Oliveira ◽  
Gilmar A. C. Teles Júnior ◽  
Desirée A. Bonfim ◽  
Carlos Magno R. Carvalho Júnior ◽  
Jéssica A. Santos ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Medium Ph ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms
Sign in / Sign up

Export Citation Format

Share Document