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US-12625124-B2 - Methods for validating medication

US12625124B2US 12625124 B2US12625124 B2US 12625124B2US-12625124-B2

Abstract

The present disclosure provides methods and systems for providing a validated drug product to an end-user or distributing business. Also provided herein are methods and systems for providing a certificate of analysis for a drug product to provide more information to a user.

Inventors

  • Adam CLARK-JOSEPH

Assignees

  • VALISURE LLC

Dates

Publication Date
20260512
Application Date
20250912

Claims (10)

  1. 1 . A method for validating a medication batch or a subset of a medication batch post-manufacturing, the method comprising: (a) obtaining a sample from the medication batch or the subset of the medication batch post-manufacturing; (b) performing an analytical test on the sample to determine an analysis result; (c) determining a validation status of the medication batch or the subset of the medication batch post-manufacturing based on the analysis result; and (d) providing the validation status to a drug manufacturer, a distributor, a pharmacy, a medical professional, a government agency, or an end user, wherein the validation status indicates that the medication batch or the subset of the medication batch post-manufacturing (i) meets or exceeds quality standards; or (ii) does not meet quality standards.
  2. 2 . The method of claim 1 , wherein the analytical test is at least one analytical test selected from the group consisting of: nuclear magnetic resonance spectroscopy, mass spectrometry, high-performance liquid chromatography, Fourier transform infrared spectroscopy, and Raman spectroscopy.
  3. 3 . The method of claim 1 , wherein the validation status is provided on a report.
  4. 4 . The method of claim 3 , wherein the report indicates a number of analytical tests performed on the sample, a number of ingredients analyzed, adherence to a quality standard, deviation from a reference quantity, dissolution test results, or any combination thereof.
  5. 5 . The method of claim 3 , wherein the report indicates one or more impurities present in the sample.
  6. 6 . The method of claim 1 , wherein the sample is in a solid form selected from the group consisting of: a pill, a capsule, a tablet, and a powder.
  7. 7 . The method of claim 1 , wherein the sample is in a liquid, cream, lotion, or gel form.
  8. 8 . The method of claim 1 , wherein the sample of a medication batch post-manufacturing is a drug prescribed by a licensed healthcare practitioner, a drug purchased over-the-counter, a drug purchased over the internet, a drug acquired from a manufacturer, or a drug acquired from a distributor.
  9. 9 . The method of claim 1 , wherein the sample is taken from a container or package containing more than one unit of the medication batch post-manufacturing.
  10. 10 . The method of claim 1 , wherein the sample is or comprises a biologic, a pharmaceutical, or a veterinary drug.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 19/029,932, filed Jan. 17, 2025, now abandoned, which is a continuation of U.S. patent application Ser. No. 18/732,336, filed Jun. 3, 2024, now abandoned, which is a continuation of U.S. patent application Ser. No. 18/381,987, filed Oct. 19, 2023, now abandoned, which is a continuation of U.S. patent application Ser. No. 18/111,314, filed Feb. 17, 2023, now abandoned, which is a continuation of U.S. patent application Ser. No. 16/615,617, filed Nov. 21, 2019, now U.S. Pat. No. 11,619,619, issued Apr. 4, 2023, which is a U.S. National Phase application of International Patent Application No. PCT/US2018/033983, filed May 22, 2018, which claims the benefit of U.S. Provisional Application No. 62/509,592, filed May 22, 2017, each of which is herein incorporated by reference in its entirety. INCORPORATION BY REFERENCE All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BACKGROUND OF THE INVENTION There is a considerable and increasing problem associated with counterfeit, impure, or substandard medications (e.g., pharmaceutical products) in both developing and developed countries. Accordingly, the ability to accurately identify, verify, and/or determine the composition, quantity, content, purity, and/or physical properties (such as dissolution rate) of medications is becoming an important issue not only for governments and corporations, but also for individuals and/or intended end-users of a product. For example, a lack of oversight for verifying identity, composition, and/or quantity of ingredients in pharmaceutical products can lead to unintended and adverse consequences for individual end-users. Various types of non-analytical methods, such as matching end-user information with the prescription, are available to the end-user. However, analytical tests in order to identify and/or determine the chemical composition, quantity, content, purity and/or physical properties of medications such as drugs and biologics or other chemicals for validation may not be available to the end-user or other businesses in the pharmaceutical supply chain post-manufacturing. Current quality-control systems may rely on many different participants, with different incentives, at different stages of a long, complicated, decentralized supply chain to each perform separate, specific analyses; each link in the chain may assume that all previous testing earlier in the chain was performed and reported correctly, and that those test results remain valid regardless of conditions and events in the interim. If any of the testing, anywhere along this lengthy and complicated chain, is falsified, improperly performed, misreported, or otherwise compromised, the problem may propagate all the way through to the end. Because such issues have been found to arise frequently, verifying the mere provenance of a medication may not be an adequate verification of quality. SUMMARY OF THE INVENTION Recognizing a need for the ability to accurately identify, verify, and/or determine the composition, quantity, content, purity, and/or physical properties of medications such as drugs, the present disclosure provides methods and systems for analyzing ingredients of medications selected from a batch using analytical tests. Validated medications from the tested batch may then be provided to an end-user or distributing businesses based on meeting quality standards. Comprehensive, independent analysis is optionally performed close to the end or at the very end of the supply chain, optionally in the final step before medications are distributed to end-users or a distributing business; this penultimate quality control technique is an alternative to relying on a decentralized collection of test results reported by various parties at different stages of the supply chain. In one aspect, provided herein are methods for analyzing a unit of a medication in order to determine a validation status of a medication batch. A batch of medication may be the whole batch produced at a manufacturer or a subset of batch that has been split off from the original batch. The method comprises: receiving the unit of the medication, wherein the unit of the medication is from the medication batch or subset of a batch; analyzing an ingredient of the unit of the medication using an analytical test thereby generating an analysis result; comparing the analysis result to a reference or derivative thereof thereby generating a comparison result; determining the validation status of the medication batch or subset of a batch based on the comparison result; and providing a validated unit of the medication to an end-user or distributing business, wherein the validated unit of