Formulations Development & Manufacturing
Formulations Development Capability
At Quality Chemical Laboratories, we pride ourselves in providing scientifically focused formulation development activities. As a resource for prototype development, QCL offers a responsive service allowing critical formulation data to be achieved in a timely manner such that key clinical timelines can be met. QCL is heavily focused on the ability to be nimble and respond to clients’ needs which is achievable in a highly collaborative team environment where science is at the forefront. The combination of QCL’s expertise in multiple areas – API synthesis, Method Development, Formulation Development- allows strong formulation development within aggressive timelines fully supported by World Class analytical support. Our experts treat you as partners, working together to provide solutions to problems.
Specialized Areas of Expertise:
- Taste Masking
- Enteric Coating
- Aqueous Tablet Film Coating
- Immediate or Controlled Release
Formulation Development Capabilities:
Pre-Formulation Studies:
- Excipient Compatibility Study
- API/ Blend Physical Characterization
- Material Compatibility Study
Small Scale Prototype Development/ Dosage Determination
Process/ Scale Up Development- Abbreviated Stability Study (multiple packaging configurations available)
- Analytical Sample Production
- Lead in Stability Study
Quality Chemical Laboratories Manufacturing Equipment List 2023
Equipment | Equipment Info | Batch Sizes |
Syntegon TPR 200 Tablet Press | 8 stations B-tooling, 8 stations D-tooling | Up to ~ 24,000 tablets per hour |
Syntegon GKF 702 Automated Encapsulator | Powder/Pellet capabilities | Up to ~21,000 capsules per hour |
Riva – Piccola 8 Station B/D Tablet Press | 4 stations B-tooling, 4 stations D-tooling | Up to ~ 10,000 tablets per hour |
O’Hara Spray Systems Labcoat M | 8.5” coating pan up to a 15” coating pan | 200 grams to 3.0 kg |
Vector GMX-LAB Mini High Shear Granulator | 4 L and 8 L product bowls | 300 grams to 2.5 kg |
Vector TFC-LAB Micro Roller Compactor | Bench top Roller Compactor | Up to 1 kg per hour |
Vector VFC-LAB 3 Fluid Bed System | Top Spray Granulation, Wurster Coating, and Drying | 500 grams to 4.0 kg |
Accofil LM-14 | Various gun sizes | Up to 5 kg |
EZ Feed Blistering | Coldform/ Thermoform | Varies |
Quadro Comil 197S | Product Dedicated Screens and Impeller | Product Dependent |
GP Mill 2.5 | Product Dedicated Screens and Impeller | Product Dependent |
Tumble Blenders with Intensifier Bar Capabilities | Sift and Blend Technology Option is available | 30mL – 2ft3 |
SADE Weight Checker | Accuracy +/- 1.0mg | Product Dependent |
Michael D. Barron, MBA
Office: (910) 338-5767
Mobile: (919) 522-9302
Michael.Barron@qualitychemlabs.com
Rodney P. Robbins
Office: (910) 859-8190
Rodney.Robbins@qualitychemlabs.com