Characterisation of Relative Bioavailability of GLA-015 in Comparison With an Oily Cannabidiol Solution (NRF 22.10) - a Multiple Dose, Randomised, 2-period Crossover-trial With Twice Daily Administration in Healthy Adult Male and Female Subjects

Glatt Pharmaceutical Services GmbH & Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions.
The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution.
Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.

开始日期2021-03-17

申办/合作机构

SocraTec R&D Concepts in Drug Research & Development GmbH

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100 项与 Glatt Pharmaceutical Services Gmbh & Co Kg 相关的临床结果

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项与 Glatt Pharmaceutical Services Gmbh & Co Kg 相关的文献（医药）

2025-11-02·EXPERT OPINION ON PHARMACOTHERAPY

The Potential of Micropellets and Mini-Tablets in Oral Pediatric Formulations with Challenging APIs

Review

作者: Poellinger, Norbert

INTRODUCTION:

As medicines for adults are often not suitable for children, pediatric formulations must be specifically provided. Micropellets and mini-tablets are ideal platform technologies for APIs challenging in terms of solubility and taste, enabling products not only for the pediatric but also for the adult and the geriatric population.

AREAS COVERED:

Micropellets offer a great variety of oral drug products, administrations and flexible dosage strengths covering the palatability issue adequately. Dispensed into capsules, stick packs or sachets, micropellets can be directly administered into the mouth, sprinkled on food or dispersed in a liquid allowing for an even broader administration spectrum than mini-tablets. Personalized medicine, including combinations of different APIs and dosage strengths, can be compounded easily.

EXPERT OPINION:

To provide pediatric medicines also in developing countries at viable cost, a harmonization of pediatric product development and supply is suggested by WHO's GAP-f approach. Close cooperation between the different stakeholders supports a focused pediatric drug development and supply concept. A specialized pediatric CDMO (PedExpert CDMO) focusing on challenging APIs could mean an important step forward toward the goal 'Medicine for the children of the world.'

Chimia

How Technical Innovations May Help to Prevent Drug Shortages in Switzerland

Article

作者: Suter, Christian ; Pöllinger, Norbert ; Mahmoud, Ahmed ; Gygax, Daniel ; Eigenmann, Kaspar ; Mosbacher, Johannes ; Hürzeler, Marianne

In this work, we investigated the technical feasibility of 'on-demand' production of selected drugs to cover their demand for a time window of 90 days. We focused on two sub-processes 'automated chemical synthesis' and 'formulation in micropellets' to enable personalized dosing. The production of drugs 'on-demand' is challenging, important, but also attractive. Switzerland could thus gain access to an additional instrument for increasing resilience for supply-critical drugs. The biggest challenge in the case study presented here is the scalability of automated chemical synthesis and the application range of micropellet formulations.

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100 项与 Glatt Pharmaceutical Services Gmbh & Co Kg 相关的转化医学

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