Integrated Pharmaceutical Services
Micro Nano Encapsulation
We help clients throughout the pharmaceutical development life cycle. Southwest Research Institute’s clinical trial supply services ensure new drugs meet FDA and CGMP requirements for sourcing, manufacturing, packaging and distribution across the clinical trial supply chain. Clients can use our fully integrated services from formulation development, analytical support, to CGMP Manufacturing of API and drug product supplied in a variety of final dosage forms.
Capsule Filling Services & Encapsulation
SwRI specializes in providing solid oral dosage forms, tablets and capsules, for early phase clinical trials. Our capsule filling services fill a niche by providing a customized approach to capsule dosage forms to meet our customer’s needs for their clinical trial supply:
A sachet-filling machine at SwRI measures out powder-based new drugs used in FDA-approved clinical trials.
- Variety of capsule sizes (00-5) and formulations (gelatin, vegetarian, enteric)
- Batch sizes from 500-500,000 capsules
- Low-dosage accuracy down to 0.5 mg
- Manufactured in ISO 7 (class 10,000) and ISO 8 (class 100,000) clean rooms
- High-potency compounds
- Blending of raw materials
- Bottling, sealing and labeling
- Oral Multi-particulates (Melt spray Congealing and fluid bed coating)
- Powder sachet filling
- Unit dose vials (lyophilized or dry powder fill)
- Clinical supply forecasting services and distribution
- Milling and micronization
SwRI chemists operate a capsule-filling machine used in FDA-approved CGMP manufacturing of clinical trial drugs.
Other services provided for CGMP manufacturing of clinical trial supplies include:
- Capsule Formulation Development
- Tablet Formulation Development
- Oral Formulation Development
- Milling Services