With combined expertise in respiratory APIs, excipients, manufacturing equipment and powder processing, INTO supports you in overcoming the challenges during development of your inhaled formulation
INTO can support you with expertise in:
Respiratory API development and manufacturing
Analytical methoddevelopment and validation
Formulation designand optimization
API - solid statecharacterization
Pre-formulation activities – API screening,Lactose screening
Solid state characterization, particle engineering using sono-crystallization, micronization using jet-milling technology and post-micronization conditioning studies.
1
API development and characterization:
Solid state characterization, particle engineering using sono-crystallization, micronization using jet-milling technology and post-micronization conditioning studies.
2
Stand-alone/Individual studies:
These studies can be designed as single stand-alone study or can be combined with other evaluations. These studies include analytical method development and validation, RLD Characterization, Pre-formulation studies, formulation development and optimization, powder filling trials and stability studies.
3
Preliminary development:
Using a stepwise approach and QbD principles, INTO starts with simple proof of concept studies to establish understanding about APIs and excipients, which can further be developed using screening experiments and process optimization into final target formulation.
4
Consultancy services:
With combined experience, your inhaled formulation development can be supported in the areas of APIs, lactose, analytical development, formulation development, scale-up and technology transfer by INTO’s expert consultants.
