CoreRx, Inc.
CoreRx, Inc.

Headquarters
6101 Johns Rd. Suite 8 Tampa, Fl. 33634

Location(s)
6101 Johns Rd. Suite 8 Tampa, Fl. 33634

Years in Drug Formulation
3 Years

Spokesperson
Brian McMillan, Director of Formulation Development and Dr. Todd Daviau, Director Pre-Formulation and Analytical Development

Web site 

Company's role in drug discovery and developmnet
CoreRx, Inc. is a full service classical pharmaceutical development and consultation organization dedicated to bringing investigational, new, and abbreviated drug applications to the market. The main facets of our business are Pharmaceutical Development Consulting, Formulation Development, Analytical Development/Validation, and Clinical Manufacturing Services.

Company's experience and expertise in drug formulation
Formulation Development personnel at CoreRx,Inc. have combined over 75 years in the Formulation Development arena in both “Big Pharma” and the contract research industry with regards to the development of IND, NDA and ANDA products. This includes formulation of solids (IR, MR, and SR), semi-solids, liquids, suspensions, ointments, gels, creams, ophthalmics, and parenterals (IV and IM).

Relationship with pharma companies
CoreRx, Inc. prides itself on a close relationship with it’s clients which caters to each and every goal and objective of the respective project. Initial contact between CoreRx, Inc. members and clients is centered on both immediate project objectives, as well as long term project goals as far as formulation development, process development, scale-up, and technology transfer of the developed formulation and process to commercial manufacturing. Each scientist employed on a particular project at CoreRx, Inc. is directly available at all times for communication with the client. There is no middle man unless desired.

Factors critical for drug formulation
These factors will obviously vary depending on the dosage form. However, chemical stability and dose uniformity regardless of dosage form are always critical considerations in the development process. At CoreRx, Inc. for example, the chemical stability aspect is approached in early stage development with studies such as excipient compatibility studies for solid oral dosage forms. Various potential excipients (tablet diluents, disintegrant’s, lubricant’s) are examined in an attempt to make predictions of ultimate dosage form stability. For each dosage form potential formulations are screened under “stressed” conditions such as 40°C/75%R.H. and even 60°C/75%R.H. storage conditions.

Scientific/business/regulatory trends impacting drug formulation
Aqueous solubility for both solid and liquid dosage forms due to compound size, morphology, salt selection, and lipophilicity of drug molecules. Also, many dosage forms in today’s market are formulated with multiple active pharmaceutical ingredients (API’s) so compatibility between these API’s becomes a major consideration which has a direct effect on the dosage form which may be chosen for commercial market.

A number of factors are having a direct impact on formulation and drug development. These include intellectual property protection (patent protection), and the cost of “getting a drug to market” because of uncertain regulatory standards determining whether a drug should be approved. If there were enhanced “regulatory standards,” as well as education to the “scientific community” of these standards it would potentially cut down on costly development activities which may or may not be necessary depending on the dosage form being developed.

Success story
CoreRx, Inc. was approached by a client who had a tri-layer tablet in early phase clinical that needed potential reformulation. The drug was a potential “Blockbuster” obesity medication with modified release of two Active Pharmaceutical Ingredients. Within a few short months CoreRx, Inc. was able to “reformulate” the tri-layer tablet into a mono-layer product with less release rate variability, enhanced chemical stability, and obvious manufacturing advantages regarding price and ease of manufacture.

How will roles of CROs and contract manufacturers change over the next few years?
Contract Research Organizations role in drug development and manufacturing will be widely enhanced in coming years with the state of the current economy and wide range lay-offs within the industry. Potential products will stay in the pipe-lines of “Big Pharma” companies but with more and more layoffs of development personnel this work will be outsourced to contract research organizations such as CoreRx, Inc. All of this will lead to bigger roles for CRO’s in the development (in particular) of IND and NDA products targeted for the market.