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Development Services
Development Services
IntelGenx has 30+ years of experience providing development services to clients and partners across the full product lifecycle of drug development. We offer a broad spectrum of development services from the R&D and pilot areas within our GMP-compliant facility. Services include formulation prototype development, technology transfer, process scale-up, regulatory support and clinical studies monitoring. We serve clients and partners worldwide.
Product Development
Product Development
Full range of development services, tailored to design customized products
FORMULATION
- One / several APIs
- Strength up to 80 mg
- API-specific formulations
- Organic / non-organic solvents
- Mono / multi layer(s)
- Taste masking
TESTING
- Permeation and Solubility testing
- Physical properties assessment
- Irritation assays
- Pharmacokinetic studies
- Porcine mucosa testing (Franz cells trials)
- Dissolution studies
INTELLECTUAL PROPERTY
- Product-specific
- Technology-specific
- Conceptual patents
- Innovative processes
Formulation Development
FORMULATION DEVELOPMENT (non-GMP)
IntelGenx provides early stage services for pre-GMP projects including formulation prototype, first prototype and production of pilot GCP batch of first prototype.
Formulation Development
IntelGenx will perform the following formulation development activities to develop a first prototype formulation:
|
FILM DRUG DELIVERY SYSTEM FORMULATION; |
TASTE MASKING; | PERMEABILITY TESTING; |
SOLUBILITY STUDY; |
| IN VITRO IRRITATION STUDY; |
LAB-SCALE PROCESS DEVELOPMENT; |
PHYSICAL CHARACTERIZATION (E,G, ELONGATION, FOLDING, ADHESION); |
EXPERIMENTAL STABILITY STUDY AT 50°C. |
Pilot Batch Manufacturing
IntelGenx will perform the following activities to produce a GCP pilot batch of the first prototype formulation:
- Documentation generation, including specifications, batch records and protocols;
- Batch manufacturing of up to five hundred (500) film drug product units as per Good Clinical Practices for phase I clinical studies – C.05.010(j) (the “GCP”);
- Raw materials testing (See Section 4.2.2);
- Testing and release of film drug product (See Section 4.2.3); and
- Stability study (See Section 4.2.4, Table 2).
Clinical Monitoring
Clinical Monitoring
IntelGenx sponsors and monitors pilot clinical phase 1 studies to assess whether developped prototype formulations meet pharmacokinetic requirements for a pivotal clinical study. Along with conducting the pilot study, IntelGenx selects and monitors contract research organizations (CROs), drafts clinical study approval documentation including CTA and IND applications, provides on-site clinical monitoring, and makes clinical recommendations for advancing the development program.
