Xcelience Formulation Development and Manufacturing

For the oral dosing route of administration, there are four main dosage form options to consider for first-in-human studies.These are API in bottle, powder in bottle (PIB), powder into capsule (PIC), and traditional formulation for tablets/capsules. All four options are utilized and each approach has associated advantages and disadvantages. Click on Paul Skultety's photo to read entire article for Contract Pharma or cut and paste http://www.contractpharma.com/articles/2009/06/formulation-development-options-to-the-clinic into your browser.

Benefits:
- Improved manufacturing outcomes as a result of applying technology in a manner consistent with the FDA's Quality by Design initiative
- Early drug development made easy - equipment appropriately scaled to client needs

Advantages:
- Scales to Fette 1200i press in the cGMP manufacturing area
- Enables early assessment of how the developed process and formula will perform in production, which can result in shortened development time, and early identification and resolution of potential formulation issues
- Cost-effective small batch production in the experimental area while obtaining all of the necessary processing parameters

Features:
- 10-Station tabletop rotary tablet press
- Measures precompression force, compression force, and ejection force for each punch
- Dies and punches are compatible with B or D series according to TSM or EU standards, which enables the employment of the same type of punches to be used in production
- The Director Software V4 Scalability Program
- This data acquisition and analysis system provides detailed analysis, such as compaction profiles, strain rate studies, single compaction event investigation, and statistical analysis of each production run

Specifications:
Model: Piccola B-10 Minipress
Tooling TSM or EU: B
Maximum tablet diameters: 16 mm
Number stations: 10
Output: 2.000 / 30.000
Compression force max.: 60 KN
Upper punch penetration: 0-6 mm
Depth of fill: 17 mm
Pitch diameter: 150 mm
Power consumption: 2 KW
Net weight: 295 Kg
Gross weight: 360 Kg

From preformulation to clinical supplies manufacturing and stability, we have one focus: the success of your project.

Preformulation:
- Polymorph Screens
- Salt Screens
- Drug Substance Characterization

Method development, qualification and validation:
- Raw material testing
- Stability sample analysis
- Dissolution testing
- Residual solvent analysis
- Chiral determination
- Cleaning evaluations
- Technical packages for drug substances

Formulation Development:
- Solids (tablets, capsules, sustained release and coatings)
- Semi-solids (ointments, creams, gels)
- Dispersed systems (emulsions, suspensions)
- Liquids (orals, ophthalmics, parenterals)

Clinical Supplies Manufacturing, Packaging and Labeling:
- API into capsule
- Tablets and capsules
- Liquid in capsule
- Semi-solids
- Non-sterile liquid
- Reference product blinding
- Matching placebo formulation
- Creation/qualification of blinded reference product
- Process qualification
- Process definition optimization
- Technology transfer

Stability Program Management

Drug Development Consulting:
- Product development planning, management and review
- Analytical development planning and review
- Project management
- Vendor selection management
- Expert testimony
- Technical due diligence
- Candidate evaluation