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SOURCE: Integral BioSystems
In response to client requests, Integral BioSystems now offers a formulation development program combining a pre-development study to determine the potential intellectual property pitfalls related to proposed client development projects.
Bedford, MA (PRWEB) February 02, 2013
Integral BioSystems LLC, led by 20+ year veteran of drug formulation development Shikha P. Barman, Ph.D., has teamed up with intellectual property firm Patents Etcetera to offer an integrated, practical approach to the development of repurposed drugs for a new indication. While regulatory hurdles are fewer with the repurposing of drugs with a well-established safety profile in humans, IP concerns around these products are significant. Prior to embarking on reformulating and redeveloping the drug for a new indication, it is strategically prudent to start the process with IP strategy to examine approaches in drug delivery to gain patent protection for the new dosage form and indication. Integral BioSystems/Patent Etcetera now offer this service.
Integral BioSystems’ niche is in nano-engineered drug delivery systems aimed at providing solutions to long-held issues in drug products, especially in low drug absorption by target tissues due to cell impermeability and insolubility. In addition to assisting drug companies in developing their dosage forms, Integral scientists are also working on novel solutions to improve the bioavailability of Class II, III and IV compounds.
The Company has developed numerous dosage forms for ophthalmic, oral, sublingual, intranasal, IV and transdermal routes. Integral BioSystems has a translational approach to drug development, customizing delivery systems to achieve the biologically effective objectives of the therapy. Dosage forms are customized to achieve sustained release or targeted, tissue-focused delivery or fast-release/instant delivery, depending upon the desired product attributes.
Once the drug-containing formulations are tested in preclinical models, the Company develops an integrated CMC plan to systematically transition the project to scale up and product development. As part of product development, Integral BioSystems specializes in efficiently developing a dosage form to manufacture and test in Phase I/Phase II first-in-man trials for proof-of-concept. The Company has a network of manufacturers/analytical houses for pharmaceutics that can fast-track the manufacture and release of the sterile dosage form for first-in-man trials.
About Integral BioSystems
Integral BioSystems is a specialty drug delivery contract research organization that offers an integrated, practical approach to formulation development projects for both small molecule and large molecule drug candidates. The Company business model is based on the following corporate objectives: (a) to be a collaborating partner in formulation development/drug product design for start-up and small companies, taking concepts from the laboratory to the clinic, (b) to re-formulate approved drugs for better efficacy and safety profiles, (c) to be a collaborating partner with API synthesis companies to develop generic drug product formats and (d) offer corporate legal services such as contract development/negotiations, patent filings and assessment of IP portfolios.
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