Complex product development



Inhalexpert carries out the development project management and the technical management.

Inhalexpert has concluded a strategic alliance with APTYS Pharmaceuticals allowing to provide services mainly in complex product i.e. formulation, analytical and stability.

Complex product focused, we provide formulation, analytical, stability.


Our added value:

Emphasizes efficiency of pharmaceutical development through optimized development process road map and approach based on science and risk (ICH Q8 and ICH Q9). Proposes optimized QbD documentation in order to demonstrate process & product understanding and control and to ensure rapid transfer of information for manufacturing and dossier.









Development of complex product

Analytical
development

Development and validation of methods
API, related substances and preservatives
In vitro dissolution
Deformulation, inverse engineering
Compatibility studies
Transfer

Quality control & ICH stability studies

Assay, in vitro dissolution, hardness, friability, disintegration, pH, viscosity, microscopic aspect, moisture content, microbiology, …
25°C, 60% RH
30°C, 65% RH
40°C, 75% RH
5°C

Products
development

Patent studies
Development strategy
Sustained release tablets or pellets
Solutions, suspensions, emulsions
Gels, creams
Injectable depot
Selection of preservatives
Transfer

Production
assistance

Scale-up and transfer
Design, installation and qualification of a production plant
Assistance to production


Efficiency of pharmaceutical development through optimized development process


Development
expertise

Micronisation
Wet granulation, drying and milling
Direct compression
Tablet compaction
Tablet coating
Inhaled product i.e. DPI, MDI, Nasal Spray and Nebulizer

Project
management

Business plan
Design intent
Process roadmap
Scientific management
Steering subcontractors
QbD project management

Development
methodology

Quality by Design ICH Q8
Risk management ICH Q9
Knowledge management
Process Analytical Technology
Capability study

Optimization of organization and ways of working

Pharmaceutical quality system ICH Q10
Situation (SWOT) and environmental analysis
Definition of target and objectives
Actions plan
Training



Some products already developed

  • Pulmonary dosage forms (Nebulizer, Dry Powder Inhaler, Metered Dose Inhaler, Nasal spray)
  • Injectable dosage forms of peptides (lyophilisate, depot)
  • Buccal bioadhesive dosage forms
  • Rectal dosage form (gels, suppository)
  • Transdermal dosage forms
  • Oral sustained release dosage form
  • Ocular dosage form (depot)
  • Nanoparticles