Oral Formulations

Clinical expertise and innovative technologies to enhance your drug’s performance

OVERVIEW

CATALENT BENEFITS CATALENT SERVICES CATALENT CAPABILITIES FACILITIES

With over 75 years of experience we have the formulation expertise to tailor your API for optimal solubility, bioavailability, and permeability. As the innovators of softgel technology, we are particularly proficient in a large range of oral dose forms, supported by broad clinical knowledge and a regulatory track record that can shorten your development time and ensure positive delivery. Our proprietary technologies such as Zydis^® fast dissolve and controlled release can further enhance your product’s performance. With our team of over 1,000 scientists and our critical mass of global facilities, we can customize our services according to your requirements and support your project through its entire lifecycle – from development to supply.

Learn more about how the following can impact your project at the formulation stage:

CATALENT BENEFITS

Innovative, proprietary technologies that enhance outcome and improve compliance
Expert scientists experienced in overcoming the challenges of potent and complex compounds
Rich variety of oral dosage forms, customized to your API needs
- Tablets: immediate-release, sustained-release, delayed-release, film-coated, layered, orally disintegrating
- Capsules: powder, granule fill
- Powders: sachets, powder in a bottle
- Pellets: can be incorporated into tablets or capsule filled
- Liquids: solutions, suspensions, emulsions
- Specialty liquids: microemulsions, self-emulsifying systems
More new chemical entities (NCEs) to market than the global competition
First-class facilities with global compliance
Personalized project management
Strategic regulatory planning and support

CATALENT SERVICES

We provide a full-range of formulated study supplies and services:

Preclinical (GLP toxicology)
Prototype formulation screening studies
“First in Man” studies
Phase I – Phase III clinical
Formulation/process optimization
Scale-up/technology transfer
Commercial manufacturing technical support

CATALENT CAPABILITIES

Our state-of-the-art equipment includes:

Direct tablet compression
Fluid bed processing (granulation, drying, coating)
High-shear wet granulation
Dry granulation (roller compaction, slugging)
High-speed tablet compression
Unit dose lyophilization
Perforated pan tablet coating
Automated capsule filling (powder, granules, pellets)
Microencapsulation
Becomix semi-solids processing
Low-humidity/moisture requirements
High-potency compound handling
DEA controlled substances (schedule I – V)
Light-sensitive compound handling
Solvent handling capability
Pediatric dosages forms
Taste-masking

FACILITIES

We have two fast dissolve dosage form facilities plants dedicated to Zydis® fast dissolve production.

Somerset, New Jersey, U.S.A.
- Research and development
- Pilot line
- Commercial line with controlled and potent drug capabilities
- FDA audited
Swindon, U.K.
- Research and development
- Pilot line with controlled and potent drug capabilities
- FDA and MCA audited
- Controlled drug capabilities

Our four oral solids facilities have strong track records for both quality and regulatory compliance.

Winchester, Kentucky
- Capabilities
  - Category I-III and solvent-based processing
  - Extrusion and spheronization
  - Commercial high shear granulation
  - Blending
  - Tablet compression
  - Hardshell capsule filling
  - Pan-coating
  - Fluid bed
- Compliance
  - Over 98% on-time, in-full delivery performance for the past 3 years Often noted by customers as one of Catalent’s top sites for quality and service
  - Over 98% on-time, in-full delivery performance for the past 3 years
  - Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
Schorndorf, Germany
- Capabilities
  - Category I-IV and solvent-based processing
  - Commercial high-shear granulation
  - Blending
  - Dry granulation
  - Extrusion and spheronization
  - Tablet compression
  - Hardshell capsule filling
  - Pan coating
- Compliance
  - Passed three FDA pre-approval inspections (PAI) and numerous inspections by national and international regulatory authorities
Somerset, New Jersey
- Capabilities
  - Preformulation
  - Non-sterile oral dosage form development
  - Analytical support for oral dosage form development
  - Small-scale commercial manufacturing for non-sterile oral dosage forms
  - Hardshell capsule filling
- Compliance
  - Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
San Diego, California