Massachusetts and Hungary
Years in Drug Formulation
Tom Bradshaw, President
|Areas of research|
|Drug Formulation Services Offered|
|•||Analytical method development||•||Bioavailability enhancement|
|Compatibility studies of active ingredients|
|Dosage form selection|
|Formulation stress testing||in silico studies|
|Manufacture of clinical supplies|
|Novel delivery system|
|Packaging compatibility assessment||Particle size reduction|
|Solubilizing water-insoluble drugs|
|Stability studies||Taste masking/flavorings|
|Other Services Offered|
|Disease Research||Target Identification|
|Lead Identification||Early Safety Tests|
|Lead Optimization||Pre-clinical Studies|
|IND Submission||Clinical Trials|
|NDA Submission||Post-marketing Studies|
|Types of Drugs|
|Peptide and Protein|
Company’s role in drug discovery and developmnet
SP Formulations has an exciting combination of broad dose form capability for pre-clinical and clinical dose preparation as well as capabilities in both the US and Europe. Sterile or injectible drugs are our strong point with lyophilization process development as well as formulation capabilities. We have sterile filling capabilities in the US ( Massachusetts) as well as Hungary. We also have strong analytical support (FDA inspected GMP/GLP) through SynomicsPharma Services at our Wareham site. We can manage your project from preformulation studies to final dose form release for clinical trials in either US or Europe.
Company’s experience and expertise in drug formulation
Our staff is very experienced in sterile, injectable, semi solid and solid dose form drug development. The leader of our technology group is Dr. Marcel Langenauer, who has over 20 years of development and commercial topical and solid drug development experience with two Swiss pharmaceutical companies, one as managing director.
Relationship with pharma companies
With clearly defined drug delivery parameters from our clients, we scope out our recommended development pathway keeping in mind the issues that could be troublesome in dealing with regulatory authorities. We structure the formulation programs so that we go from simple proof of concept to more complete formulations as our clients succeed with in vitro and in vivo testing. Timeliness, communication and responsiveness are key to our project management success.
Factors critical for drug formulation
A robust analytical strategy, good understanding of drug solubility, formulation stability and bioavailability are the key factors. Of course the desired delivery profile along with the dose form is also essential. An early screening process to define the range of concentrations possible and the early DMPK profile will help steer us in our later formulation work. Usually we can accomplish this early screening and formulation development in a four week time.
Scientific/business/regulatory trends impacting drug formulation
Perhaps the most important trend is the movement to large molecules and the related formulation issues. This and the decreased solubility of many new drug candidates make formulation a challenge.
Whereas biotechs and pharma have sought approval in the US as their first goal, now many biotechs are seeing the advantages of European development or development in other regions such as Eastern or Central Europe, and India/China/Brazil. Each of these areas can offer benefits of speed, partners, lower costs, and other benefits over the traditional venues. With the FDA-drug approval process becoming more difficult and slower, companies are looking for ways to succeed that are faster and less expensive.
One of our most rewarding success stories involved the development of a depot formulation for a client looking for a release profile on the order of 21 days. Using non-proprietary methods, we were able develop a simple formulation which allowed the client to show ‘proof-of-concept’ in animal models; thus facilitating additional funding for their program.
How will roles of CROs and contract manufacturers change over the next few years?
There is clearly a trend to place complete projects with a single CRO (less individual studies; more complete drug development projects). The highly fragmented CRO marketplace (over 1000 companies; the top twenty companies representing less than 50% of market) there will be increased pressure to consolidate in the CRO space.
Filed Under: Drug Discovery