# US 10,308,414 B2 · Method and system for calculating a suitability indicator > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,308,414 B2 - Document ID: US10308414B2 - Status: Granted - Kind: B2 - Application number: 15/308,505 - Filed: 2015-05-05 - Published: 2017-08-31 - Granted: 2019-06-04 - Earliest claimed: 2014-05-05 - Assignees: Boehringer Ingelheim International GmbH - Applicants: Boehringer Ingelheim International GmbH - Inventors: Eduard Balthes - Web page: https://patentgrep.com/patent/US10308414B2 ## CPC - B65D 79/02: Arrangements or devices for indicating incorrect storage or transport ({B65D79/005 takes precedence } ; measuring devices G01) - A61J 1/03: for pills or tablets (containers for pills or tablets with special dispensing means therefor B65D83/04) - G01N 15/08: Investigating permeability, pore-volume, or surface area of porous materials - G01N 17/00: Investigating resistance of materials to the weather, to corrosion, or to light - G01N 33/15: Medicinal preparations {; Physical properties thereof, e.g. dissolubility} - B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Methods and systems for calculating a suitability indicator which corresponds to a suitability of a packaging system for packaging a substance, where a stability indicator which corresponds to a stability of the substance or of a component of the substance is determined as a function of at least one ambient condition, preferably the relative humidity and/or temperature of the environment of the substance, and the suitability indicator is calculated with at least one parameter relating to the ambient condition and with the stability indicator of the substance. ## Claims ### Claim 1 A method, comprising: computing by simulation a respective suitability indicator for each of a plurality of packaging systems, where each such packaging system is a candidate for packaging a substance, wherein each suitability indicator corresponds to a respective suitability of a respective one of the plurality of packaging systems to protect the substance under defined climatic ambient conditions, wherein the suitability indicator is computed based on: (i) a stability indicator, which corresponds to at least one of a physical and chemical stability of the substance, or of a component of the substance, and which is determined as a function of at least one ambient condition of the substance, and (ii) a permeation model, which includes: (a) sorption data of the substance or parameters corresponding thereto, (b) at least one of the sorption data of the package, permeation data of the package and the at least one parameter relating to the at least one ambient condition of the substance; and selecting one or more of the plurality of packaging systems based on the suitability indicator. ### Claim 2 (depends on 1) The method according to claim 1, wherein the at least one ambient condition is a relative humidity or temperature of the surrounding area of the substance, the surrounding area being in direct contact with the substance. ### Claim 3 (depends on 1) The method according to claim 1, wherein the ambient condition is computed with at least one parameter relating to the ambient condition, and each of the respective suitability indicators is calculated with the ambient condition that has been computed. ### Claim 4 (depends on 1) The method according to claim 1, wherein each of the respective suitability indicators corresponds to a development over time of the uptake of water by the substance, or a development over time of a degradation of the substance or a component of the substance, disposed within a corresponding one of the packaging systems. ### Claim 5 (depends on 1) The method according to claim 1, wherein each of the respective suitability indicators represents or predicts a stability of the substance when packaged within a corresponding one of the packaging systems. ### Claim 6 (depends on 1) The method according to claim 1, wherein a development over time of an uptake of water, or of a water content, of the substance are computed using the permeation model, using said ambient conditions of the substance. ### Claim 7 (depends on 1) The method according to claim 1, wherein at least one of: the stability indicator of the substance is determined independently of the sorption data of the plurality of packages, and sorption data of the plurality of packages are determined independently of the stability indicator of the substance. ### Claim 8 (depends on 1) The method according to claim 1, wherein the substance is being present as a solid in the form of a number of discrete units, in the form of a loose dry compacted material, in the form of tablets or in the form of capsules. ### Claim 9 (depends on 1) The method according to claim 1, wherein the stability indicator is determined on the basis of properties of the substance after the substance has been exposed, in an open or unpackaged state, to constant ambient conditions over a defined period of time. ### Claim 10 (depends on 1) The method according to claim 1, wherein the stability indicator comprises a plurality of stability indicator values which correspond to properties of the substance after the substance has been exposed, in an open or unpackaged state, to different ambient conditions, which are constant for the particular stability indicator value over different, defined periods of time. ### Claim 11 (depends on 9) The method according to claim 9, wherein a group of stability indicator values is determined, the group of stability indicator values being determined particular ambient conditions according to at least one of: by varying only the relative humidity of the surrounding area of the substance, and by varying only the temperature, while keeping the water content of the substance constant, and stability indicator values are determined for different periods of time over which the substance has been exposed to the particular ambient condition. ### Claim 12 (depends on 9) The method according to claim 9, wherein the suitability indicator is computed with these stability indicator values and with a plurality of parameters of the plurality of packaging systems relating to the particular ambient conditions, the parameters representing the behavior of the plurality of packaging systems in terms of different ambient conditions. ### Claim 13 (depends on 1) The method according to claim 1, wherein the suitability indicator comprises a plurality of suitability indicator values which correspond to properties of the substance or predict properties of the substance, after the substance, packaged using one of the plurality of packaging systems, has been stored over different periods of time. ### Claim 14 (depends on 1) The method according to claim 1, wherein the suitability indicator is computed by extrapolating or predicting the stability characteristics of the substance when packaged using one of the plurality of packaging systems, using the stability indicator and one or a number of parameters of the plurality of packaging systems. ### Claim 15 (depends on 1) The method according claim 1, wherein at least one of the following is also taken into account when computing the suitability indicator: a water content or a relative humidity of an atmosphere which is found or is to be enclosed within the package in the packaging process using the plurality of packaging systems, and which is in direct contact with this substance when it is packaged in the plurality of packaging systems, a water content or a relative humidity of the packaging material, a water content or a relative humidity of the substance. ### Claim 16 (depends on 1) The method of claim 1, wherein: the permeation model includes: permeation data of a package or one or more packaging materials of the plurality of packaging systems, sorption data of the package or one or more packaging materials of the plurality of packaging systems, and sorption data of the substance, and at least two different ones of the plurality of packaging systems are evaluated by comparing at least two of the respective suitability indicators with one another and with at least one target value, and the one or more packaging systems is or are automatically selected or discarded using the results of the comparison or a better suitability of one packaging system compared with another packaging system is indicated, signaled or displayed. ### Claim 17 (depends on 16) The method according to claim 16, wherein a combination of packaging material or packaging materials and the geometric shape of the packaging material(s) forming the package is selected or determined, so that the combination is suitable for packaging the substance and enables subsequent storage to take place under certain climatic conditions over a given period of time without any degradation of the substance exceeding a certain threshold when stored under these conditions in the packaged state. ### Claim 18 (depends on 1) The method according to claim 1, wherein the package is characterized at least by the chemical composition of one or more packaging materials and by a geometric shape of the packaging material or materials and also by process conditions of the packaging process or its effects on at least one of the substance, the packaging materials and the atmosphere enclosed together with the substance during the packaging process. ### Claim 19 (depends on 1) The method according to claim 1, wherein the package is characterized by its chemical composition and a geometric shape, while sorption data and permeation data of the package take account of both the chemical composition and the geometric shape. ### Claim 20 (depends on 1) The method of claim 1, wherein each stability indicator is determined depending on only one particular stability influencing factors or ambient conditions, among a plurality of such stability influencing factors or ambient conditions, while further or the remaining stability influencing factors or ambient conditions are kept unvaried. ### Claim 21 (depends on 20) The method according to claim 20, wherein the stability influencing factors or ambient conditions comprise at least one of a relative humidity of the ambient or atmosphere being in direct contact with the substance, an absolute water content of the substance, and the temperature of the substance. ### Claim 22 (depends on 20) The method according to claim 20, wherein each stability indicator is a function and is determined depending on time, such stability indicator indicating at least one of a physical and chemical stability of the substance or of a component of the substance as a function of both time and the particular one of the stability influencing factors, and wherein the function is expressable or interpolable as a hypersurface. ### Claim 23 (depends on 1) The method of claim 1, wherein a set of multiple samples of the substance are examined at the same time under different ambient conditions, wherein a particular one or more of the samples of the substance is or are exposed to conditions where a minimum stability of the samples of the sample set can be expected, and wherein one or one of the particular one or more samples is examined at several subsequent time-points until a stability degradation of the particular one or more samples is determined and only after this determination, one or more of the further samples of the set are examined as well.