Formulation Development

The Group uses our internal resources and expertise to develop pharmaceutical products from the "lab to the loading dock." Logical deduction based on previous delivery systems formulation with known actives has yielded human trials in as little as four months for some clients. In the past, we have developed formulations (including scale up and clinical/NDA batches) for human Rx and vet products.

Formulation examples include:

Human

* Oral delivery of Rx protein; formulation assistance, new delivery design and scale up.

* MDI reformulation; component compatibility, dose to dose uniformity, patient use trials, release testing, failure analysis, and system improvement.

* Vaginal Rx suppository; formulation assistance, scale up, and clinical trial batches.

* Sustained release Rx corticosteroid; formulation, scale up, and clinical trial batches.

* Topical aqueous-based Rx cream; packaging design, clinical trial manufacturing management, and analytical method design.

* Nasal delivery of recombinant peptide; formulation and clinical batches.

* Buccal delivery of opiate for acute pain management; pre-formulation and clinical trial batches.

* Controlled release; steroids, corticosteroids, friendly bacteria.

Veterinary

* Topical wound; formulation, scale up, and system improvement.

* Micro-encapsulated active; formulation assistance, taste masking, and texture control.

Manufacturing support, Problem solving, Validations, and Failure Analysis

McCoy Enterprises LLC. is a hands-on team. Our practical knowledge and approach form a unique view of a problem or project. By initially using low-tech approaches to find the right path, we have saved several customers hundreds of thousands of dollars. We have been able to find low-cost, practical solutions by assembling teams of manufacturers, engineers, and scientists with extensive corporate backgrounds.
 
Our teams include mechanical engineers, material scientists, chemical engineers, pharmaceutical scientists, manufacturing and industrial engineers, chemists, pharmacologists and others depending on the specific problem to be addressed. Most of our team members have over 20 years experience with large multinational manufacturing companies.
 
With a wide range of experience, McCoy Enterprises LLC. can provide a broad range of tools to new situations. For instance, using high speed photography to record the actuation of a metered dose inhaler, we were able to show that acoustic resonance was influencing product performance.
 
The team rapidly and efficiently trouble shoots manufacturing process problems. Some recent areas are outlined below. We specialize in solving operational issues using our scientific, engineering and analytical talents. In one case, a recall was prevented when we were called to help solve an out of tolerance specification in an end product. The diagnoses was a complex interaction between a second and third tier supplier. The problem was isolated and fixed. In another case, by identifying foreign materials and determining its source, we increased product yield by ten fold.
 
Extractables and Leachables We have performed Extractable and Leachable characterization of primary packaging components including new method development for many of the pharmaceutical industry leading companies. We can support your primary packaging component suppliers by establishing extractable profiles and including those profiles in the suppliers DMF. Programs suited for NDA filings, ongoing monitoring of incoming material (material of construction changes, etc.), in accordance with recently published draft guidelines from the FDA on container closure systems are our forté.