This article shows the content of a poster which was presented at the ๐๐จ๐ฃ๐ณ๐ ๐ฐ๐ผ๐ป๐ณ๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ ๐ถ๐ป ๐๐น๐ฎ๐๐ด๐ผ๐ 2023
Malaria & Treatment Challenges
Children aged under 5 years are the worst affected by malaria, causing about 10 % of all childrenโs deaths in regions where malaria is endemic. Fixed dose combination (FDC) of Artesunate (AS) and Amodiaquine (AQ), are recommended by the WHO for malaria treatment. Currently AS/AQ is only available as bilayer tablets which are crushed for paediatric administration causing noncompliance due to the bitter taste of AQ. The aim of this work is to develop a FDC of AS/AQ taste masked micropellets (diameter <250 ยตm) with improved palatability and mouthfeel for oral administration in young children. The manufacturing of effectively taste masked micropellets is facilitated using the MicroCoatโข technology.
MicroCoatโข Technology
What is MicroCoatโข Technology?
Drug is layered on MCC microspheres (Celletsยฎ,100-200 ยตm) in a fluidized bed coater where dry powder glidant is added into coating chamber by external feeding port to eliminate agglomeration.
- Reducing inter-particular cohesive forces
- “in-situ” stabilization of coating process
- Reducing agglomeration/aggregation
- Significantly increasing production yield
- Increasing spray rate
Application in Lab and Pilot Scales
Final Product Evaluation
Excipient Safety Evaluation
Total excipients intake was calculated at two dose strengths: 25 mg/67.5 mg and 50 mg/135 mg (AS/AQ) for use in children 4.5 kg to <18 kg, corresponding to (2 months-5 years). Excipients safety profiles were evaluated against the โGenerally Regarded as Safeโ (GRAS), โSafety and Toxicity of Excipients for Paediatricsโ (STEP) and โFDA Inactive Ingredientโ databases. No excipient safety concerns were raised following the evaluation process to be used in the target population.
Conclusions
An effective taste masked coating was successfully applied on drug loaded micropellets using MicroCoatโข technology on both laboratory and pilot scale giving an acceptable paediatric ASAQ FDC product which can improve adherence of anti-malarial treatments in children under 5 years. The final formulation will be further assessed by acceptability and biorelevant dissolution studies.
See the full posterย on “Taste Masked Artesunate/Amodiaquine Micropellets in the Fight Against Malaria”ย here
(click the picture to enlarge the poster)
Source: Fluid Pharma, Unitaid,
Authors: Alan Reader, Dina Shokry, Annette Grave, Janosch Kilnger, Maurice Wilde,Dan Baker, Sangeetha Marri, Catherine Tuleu, Sejal Ranmal, Daniel Schaufelberger, Harun Sinha, Richard Lasky, Sandra Klein, Frank Karkossa, Kavil Patel, Stephanie De Sa, Marques Basset & Fang Liu
Poster “Taste Masked Artesunate/Amodiaquine Micropellets in the Fight Against Malaria” ๐ณ๐ฟ๐ผ๐บ ๐๐ต๐ฒ ๐๐จ๐ฃ๐ณ๐ ๐ฐ๐ผ๐ป๐ณ๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ 2023 ๐ถ๐ป ๐๐น๐ฎ๐๐ด๐ผ๐
