Patheon Inc.
Patheon Inc.

Headquarters
PO Box 110145, Research Triangle Park, NC 27709-9998, US

Location(s)
PO Box 110145, Research Triangle Park, NC 27709-9998, US

Years in Drug Formulation
6 Years

Web site 

Company's role in drug discovery and developmnet
"Our goal is to provide customers with 'best in class' development services which accelerate customer molecules to market efficiently. We will continue to add new technologies and value-added services to meet the development needs of our customers."

Patheon offers a comprehensive array of contract manufacturing and packaging services from an international network of facilities located throughout Europe and North America. With a wide range of capabilities for virtually all finished dosage forms and packaging formats and a strong history of quality, Patheon can meet your outsourcing needs through flexibility, creativity, and service excellence.

Company's experience and expertise in drug formulation
Patheon has strong expertise in development of controlled and immediate release formulations for non-parenteral dosage forms such as tablets, capsules, dry powders, liquids, and semisolids like creams, ointments, gels, etc. Patheon has demonstrated expertise in development of parenteral dosage forms both liquids and freeze-dried. Liquid formulations include dispersed dosage forms as suspensions, emulsions, and liposomes.

Patheon’s formulation group has been conducting the development of a range of entities covering small molecules, proteins, peptides, enzymes, and monoclonal antibodies for more than 12 years. Patheon has developed several special dosage form development capabilties such as controlled release formulations, high potency compound development, poorly soluble drug solubilization and bio-enhancement, lyophilization, etc.

Patheon focuses on rapid development of new pharmaceutical products for Proof of Concept or Phase 1 studies. This approach called "Quick to Clinic" utilizes standardized, streamlined development programs to produce fit for purpose formulations for a range of oral dosage forms.

Factors critical for drug formulation
It is important to understand the physico-chemical properties of the API and lot to lot variations throughout formulation development process. This is addressed by our 'in house' capability to conduct pre-formulation studies and to conduct full material characterization of the API. By understanding the properties, time & cost savings can be made in the development process.

For early phase we focus on speed of development to allow our clients to reach their key clinical milestones earlier. We couple this with the use of miniaturization techniques to minimize the amount of costly API Selection of an appropriate dosage form type plus formulation composition is aimed at maximizing bioavailability across the wide dose range typical of Phase 1 studies.

Another critical factor for success is the robustness of composition and process. Patheon undertakes design of experiments and establishes critical processing parameters to develop a scalable, manufacturable, and stable product.

Scientific/business/regulatory trends impacting drug formulation
Techniques for dealing with very low aqueous soluble compounds with low oral bioavailability are an increasing need for new chemical entities.

Improving solubility & bioavailability. Safe handling of highly potent drugs. Increasing requirement for modified release formulation development. We also see a trend in development of fixed dose combination product development as line extension of existing molecules. The properties of two or more API’s in the same dosage form introduces challenges in formulation and stability.

Techniques for dealing with poorly soluble compounds with low oral bioavailability are an increasing need.

Quality by design and PAT drive establishment of robust formulations.

Business trend is focused on bio-pharmaceuticals. Most of the enquires we receive are from biotech companies or are about reformulation of existing API obtained by recombinant techniques.

For early phase, the so called Phase 0 or microdosing studies are beginning to become more prevalent. This allows very early PK information to be obtained with reduced toxicology burden. For later phase development, design of experiments, and formulation design space analysis are being encouraged by authorities.

Success story
Here following some case studies where Patheon has added value to the formulation development of clients’ projects:

Client subcutaneous / IV formulation with a high osmolality. API present in a carrier because of extreme handling difficulties. Existing client carrier system resulted in an osmolality that was too high for a subcutaneous / IV formulation. Patheon developed an alternative API carrier system that gave the same benefits in terms of API handling characteristics but reduce osmolality.

Extreme processing problems encountered when developing a tablet formulation from an existing capsule formulation (sticking during compression). A number of conventional solutions were initially tried without success. Patheon understanding of the underlying causes of the issue led to its resolution involving an unconventional use of common excipient. This in combination with the development strategy used led to the enhancement of all of the products characteristics (processing and finished product).

Client required very quick development of a Phase 1 formulation containing a high API content. This was initially intended to be based on a formulation and process supplied by client. API had extremely poor processing characteristics (extremely low density and highly cohesive). Patheon resolved these issues by developing a new formulation and process in an extremely short timelines. Conventional solutions to API cohesiveness were unsuccessful e.g. use of various glidants and mixing methods. The processing issues were resolved by the novel use of an excipient and a suitable formulation for Phase 1 was developed.

How will roles of CROs and contract manufacturers change over the next few years?
Outsourcing will be expanding dramatically; competitions among contract manufacturer will require an higher level of specialization in new techniques to become more attractive to business (in particular for lyophilization and poorly soluble compounds).

There will be an increase in projects involving formulation of large molecules (pepites & proteins).