Overview

Stable isotopes are non-radioactive chemical tracers that are relatively unexploited by the pharmaceutical industry as compared to the natural sciences. Stable isotope ratios are measured by combustion and mass spectrometric analyses of either bulk phases or specific compounds. Bulk phases are typically analyzed by either offline combustion followed by dual-inlet mass spectrometry or by online combustion coupled with isotope-ratio-monitoring/mass spectrometry (irmMS). Specific compounds are analyzed by either gas chromatography coupled with irmMS (irmGCMS) or by liquid chromatography coupled with irmMS (irmLCMS), depending on the chromatographic properties of the analytes. Jasper (1999, Pharm. Technol. 23 (10) reviews nine major points regarding the properties and uses of stable isotopes in the pharmaceutical industry, including the suggestion of Isotopic Fingerprint™ and Isotopic Pedigree™ Identification of Active Pharmaceutical Ingredients (APIs) and drug products. The problems of pharmaceutical Product and Process Counterfeiting are illustrated here.

Operating Models

MIT LLC has two operating models, the Outsourced Service Lab Model and the In-Firm Licensed Model.

In the Outsourced Service Lab Model, samples are sent to MIT LLC for analysis. We typically provide the isotopic data with documented interpretation of the isotopic results, typically in publishable quality. Virtually all clients perform an outsourced study before advancing to industrial scale.

With the In-Firm Licensed Model, MIT LLC will license the use of its isotopic authentication technologies to a firm for a license fee that is proportional to number of samples analyzed.

In either case, please contact for the details of the business model. (Contact Us.)

Costs (US)? Analytical costs for ISP (per lot of 10⁶ tablets) are estimated as follows. At the R&D level, bulk isotopic analysis (e.g., C, H, O, N, S isotopes) normalizes to ~1.5 cents/100-tablet bottle. Prices decrease significantly at the manufacturing scale.

Test Studies

Patent Coverage

MIT LLC has a patent or patents pending in two areas of stable isotope application: Stable-Isotopic Product Authenticity and Stable-Isotopic Process Authenticity. In Stable-Isotopic Product Authenticity, we use the natural or ambient stable-isotopic compositions of pharmaceutical materials (raw materials, synthetic intermediates, Active Pharmaceutical Ingredients (APIs), excipients, and finished drug products) to trace the identity of these materials within the manufacturing environment and the marketplace (“Isotopic Fingerprints” or “Nature’s Fingerprint®”; see Jasper, 2004). We have a patent granted in this area, with 15 more pending. We have a patent pending in Stable-Isotopic Process Authenticity in which we can trace the Isotopic Pedigree ℠ of synthetic pathways by measuring the Isotopic Fingerprints of each of the reaction steps. This approach is applicable in areas of Process Analytical Chemistry, Process Control, and Process Patent Protection (see Jasper et al., 2005 or contact us about your particular synthetic pathway).

Read: Connecticut High-Tech Company Uses "Natures Fingerprint" To Add Value to patient Portfolios
(CURE: The Bioscience Network of CT)