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Showing posts tagged as : #manufacturing

Feature article

Cambrex

March 16, 2023

Pediatric dosage forms: Rising demand for pediatric dosage forms requires reformulation and development expertise but also to-scale manufacturing capabilities

Pharmaceutical companies are looking to pediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. The desire to develop pediatric dosage forms (PDFs) of drugs with existing adult indications has two main drivers: (1) the US Food and Drug Administration’s (FDA’s) role in limiting off-label use in pediatric patients, which aligns with the FDA’s role in ensuring the safety and efficacy of approved products for all patients; and (2) sustaining revenue growth through ...

Pharmaceutical companies are looking to pediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. The desire to develop pediatric dosage forms (PDFs) of drugs with existing adult indications has two main drivers: (1) the US Food and Drug Administration’s (FDA’s) role in limiting off-label use in pediatric patients, which aligns with the FDA’s role in ensuring the safety and efficacy of approved products for all patients; and (2) sustaining revenue growth through pediatric exclusivity that typically adds 180 days of intellectual property protection and thus almost 6 additional months of branded drug sales, which in some cases could translate to billions of dollars in revenue.

#scale-up #manufacturing #pediatric drug development #dosage form

Feature article

Parmaceutical manufacturer

Feb. 27, 2023

Innovations in oral solid dosage forms

Dr. Klaus Pollinger and Dr. Martina Breuer, Aenova Group, explore the challenges of development and commercial manufacturing of oral solid dosage forms, from a CDMO perspective.

#HPAPI #CDMO #manufacturing #Solid dosage forms #R&D #production

Announcement

MySTYL'One

July 11, 2022

Charge reduction assisted production of diminutive fluid bed granules for high drug load minitablets

The present works demonstrated the feasibility of producing high drug load minitablets from a cohesive, electrostatic–prone fine drug powder. The study is available in the PAPERS section.

Find others papers here and learn about

  • Tablet Disintegration and Dispersion under In Vivo-like Hydrodynamic Conditions
  • Influence of the porosity of cushioning excipients on the compaction of coated multi-particulates
  • Effects of Particle Surface Roughness on In-Die Flow and Tableting Behavior of Lactose

#STYL'One Nano #manufacturing #parameters #database #optimization

Announcement

MySTYL'One

June 23, 2022

Development and optimization of an Automated Microscale Manufacturing System for Oral Solid Dosage Forms

The present works detail an ambitious “Digital Medicines Manufacturing" (DM²) program, which aims to transform medicines development and manufacturing productivity, driving patient-centric supply through the creation and adoption of Industrial Digital Technologies (IDTs). Medelpharm is part of this innovative project. The 2 posters talking on it are available in the PAPERS section.

Find others papers here and learn about

  • Predictive modelling of powder compaction for binary mixtures using the fi...

The present works detail an ambitious “Digital Medicines Manufacturing" (DM²) program, which aims to transform medicines development and manufacturing productivity, driving patient-centric supply through the creation and adoption of Industrial Digital Technologies (IDTs). Medelpharm is part of this innovative project. The 2 posters talking on it are available in the PAPERS section.

Find others papers here and learn about

  • Predictive modelling of powder compaction for binary mixtures using the finite element method
  • Amorphous-based controlled-release gliclazide matrix system
  • Process Modeling and Simulation of Tableting—An Agent-Based Simulation Methodology for Direct Compression

#STYL'One Nano #manufacturing #parameters #database #optimization

Press review

www.korsch.com

Sept. 6, 2021

Key considerations in multilayer tableting

“The manufacturing of multilayer tablets may seem to be simple duplications of the basic single-layer compression cycle, but in reality, the process is far more complicated. In this article, KORSCH outlines the key considerations in the production of multilayer tablets and defines the key parameters for multilayer process optimization.” Click here for full article

#multilayer #manufacturing

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