Ready-to-use detector

Abstract

Provided herein are systems and methods for detecting the temperature of a pharmaceutical product and indicating whether the pharmaceutical product is ready for use after a specified amount of time has elapsed. The detector provided herein includes a temperature sensor configured to be attached to a pharmaceutical product containing an active pharmaceutical ingredient (API) therein and configured to detect the temperature of the pharmaceutical product, at least one timer configured to begin measuring an elapsed time when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a bleach temperature, and at least one indicator configured to generate an indication that the pharmaceutical product is ready for use when the specified amount of time has elapsed in the at least one timer.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to detectors for pharmaceuticals, and more particularly to detectors that determine and indicate when a pharmaceutical is ready for use. [Background technology]

[0002] Pharmaceutical products are distributed with instructions for use (IFU) on the label and / or package insert that inform users how and when to use the product. For example, pharmaceutical products may contain an active pharmaceutical ingredient (API) that must be stored in a refrigerated environment (e.g., refrigerator, freezer, etc.) until consumption to maintain the API's potency, sterility, and / or physical form. The duration that an API can be maintained outside of a controlled refrigerated environment varies from API to API. The IFU informs users of the duration that the API must be in an ambient environment (e.g., outside of a refrigerator) before use, as well as the maximum time that the API can be maintained outside of a refrigerator before it expires.

[0003] Drug delivery performance is highly dependent on the temperature-sensitive formulation properties of the API, such as viscosity and density. The API can be, for example, injected (e.g., manually by a user or using an auto-injector), orally ingested / consumed, or inhaled. When injecting a drug through a needle, the injection force (e.g., in the case of manual injection) and injection time (e.g., in the case of mechanically assisted delivery such as an auto-injector) are highly dependent on the temperature of the formulation. API temperature is inversely proportional to viscosity, injection time, and injection force, such that lower temperatures result in higher viscosity, longer injection times, and greater injection force requirements. Therefore, a drug product (e.g., an API) needs to be outside of a controlled, cooled environment within the ambient environment for a certain duration to reduce viscosity and increase temperature, thereby reducing the force and injection time required to inject the API (manually or through the use of an auto-injector). Summary of the Invention

[0004] Provided herein are systems, devices, and methods for determining and indicating when a pharmaceutical product is ready for use. The detectors described herein can detect the temperature of the pharmaceutical product and, once it reaches or exceeds a bleach temperature, measure the elapsed time and indicate whether the pharmaceutical product is ready for use after a specified amount of time has passed.

[0005] As mentioned above, pharmaceutical products are traditionally distributed with instructions for use (IFU) on the product label and / or package insert that inform users how and when to use the product. For example, pharmaceutical products may contain active pharmaceutical ingredients (APIs) that must be stored in a cool, controlled environment (e.g., refrigerator, freezer, etc.) until consumption to maintain the stability of the API. The IFU informs users of the minimum and maximum durations that a pharmaceutical product containing the API must and can be left at ambient temperature (e.g., room temperature) before using the product. APIs may be required to be left at room temperature because, at least, drug delivery performance (e.g., injection time and / or injection force) can be highly dependent on the viscosity of the fluid, which is inversely proportional to the temperature of the API. Thus, at lower temperatures, the viscosity of the API is higher, which results in extended injection times and greater injection forces that may exceed the capabilities of the user and / or auto-injector. Despite informing the user of the waiting time in the IFU, as will be explained in more detail below, the waiting time observed by the user before using the medication is often inefficient, inaccurate, and ignored by the user.

[0006] For example, a user may not read the IFU materials, but rather, roughly estimate the duration for which the drug product must remain outside of a controlled refrigeration environment before using the drug product. In some embodiments, a user may not follow the IFU or the medical professional's instructions at all, but rather, attempt to use (e.g., inject) the drug product's API without waiting any duration after the drug product is removed from the controlled refrigeration environment. In some cases, a user may forget about the drug product after removing it from the controlled refrigeration environment, leaving the drug product in the ambient environment for a duration that exceeds the maximum duration for which the drug product may remain in the ambient environment, causing the API to expire.

[0007] In addition, the duration a medication may need to remain outside of a refrigerated environment may vary based on the temperature of the environment in which the medication is placed. For example, if a medication is placed in an environment warmer than ambient temperature, it may require less time to reach a suitable temperature for use. On the other hand, if a medication is placed in an environment cooler than ambient temperature (but still above the temperature range of the controlled refrigerated environment), it may require more time to reach a suitable temperature for use. In some instances, a medication may never reach the desired use temperature or may require excessive time to reach the desired use temperature. Additionally, a user may use multiple different medications each day, and each medication may require a different duration to warm to the appropriate use temperature, or the appropriate use temperature may vary from medication to medication. Thus, a user may incorrectly correlate the waiting time with a given medication and use those medications incorrectly.

[0008] Incorrect use of an API can lead to many problems for users. For example, when an API is injected into a user, the injection time may be prolonged if the API has not reached the appropriate temperature for use. As discussed above, this is caused by the API's higher viscosity, which is inversely proportional to the API's temperature. In some cases, an API may not be fully injected (or may not be injected at all) if it is not at the appropriate temperature for use. For example, low temperatures and high viscosities may require a large injection force that exceeds the user's capabilities, or, if the API is injected with an auto-injector, may require a large injection force that exceeds the maximum spring force that can be exerted by the auto-injector's spring. Furthermore, injecting an API that has not reached the appropriate temperature can cause user discomfort and pain, at least at the injection site. Pain can result from at least the low temperature of the API and / or the high viscosity of the fluid, because the low temperature and high viscosity prevent the fluid from dispersing once injected. Additionally, if a drug product is left outside of a controlled, refrigerated environment for longer than the maximum notified duration (e.g., if the user forgets about the drug product after removing it from the refrigerated environment), the drug product may lose its effectiveness or, even worse, expire. For example, the sterility of the drug product may be compromised, and the physical form of the API may shrink, thus rendering the drug product unsuitable for use.

[0009] Provided herein is a detector configured to be attached to a pharmaceutical product. The detector is configured to automatically detect the temperature of the pharmaceutical product, measure one or more elapsed times once one or more bleach temperatures are reached or exceeded, and indicate whether the pharmaceutical product is ready for use after a specified length of time. By tracking both time and temperature, the detector can reduce any risk of user confusion and more efficiently notify the user when the pharmaceutical product is ready for use. Pharmaceutical products may include, for example, injectors (e.g., autoinjectors, syringes, manual injectors, etc.) and containers (e.g., vials, bottles, cartridges, etc.) that contain or are configured to contain active pharmaceutical ingredients (APIs) (e.g., pharmaceuticals, drugs, antibiotics, vaccines, medications, etc.).

[0010] In some embodiments, a detector configured to be attached to a pharmaceutical product containing an active pharmaceutical ingredient (API) therein is provided, the detector comprising: a temperature sensor configured to detect a temperature of the pharmaceutical product; at least one timer configured to begin measuring an elapsed time when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a bleach temperature; and at least one indicator configured to generate an indication that the pharmaceutical product is ready for use when an amount of time specified by the at least one timer has elapsed.

[0011] In some embodiments, the specified amount of time is selected to correspond to when the active pharmaceutical ingredient (API) within the pharmaceutical product is ready for use.

[0012] In some embodiments, the specified amount of time is selected to correspond to the amount of time it takes for an active pharmaceutical ingredient (API) contained within the pharmaceutical product to reach the desired temperature when placed in an environment within standard room temperature range.

[0013] In some embodiments, the bleaching temperature corresponds to a temperature outside the standard refrigeration temperature range.

[0014] In some embodiments, a pharmaceutical product is provided, the pharmaceutical product comprising: a container configured to contain an active pharmaceutical ingredient (API); and a detector disposed adjacent to the container.

[0015] In some embodiments, the container comprises a syringe configured to contain an active pharmaceutical ingredient (API).

[0016] In some embodiments, the injector comprises an auto-injector.

[0017] In some embodiments, the temperature sensor determines the temperature of the active pharmaceutical ingredient (API) based at least in part on the temperature of the container.

[0018] In some embodiments, the detector is removably attached to the container.

[0019] In some embodiments, the detector comprises a user-controlled actuator configured to activate the temperature sensor.

[0020] In some embodiments, the at least one timer is configured to begin measuring a second elapsed time when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a second bleach temperature.

[0021] In some embodiments, the second bleaching temperature is higher than the bleaching temperature described above.

[0022] In some embodiments, a first timer of the at least one timer is configured to measure an elapsed time when a bleach temperature is detected, and a second timer of the at least one timer is configured to measure a second elapsed time when a second bleach temperature is detected.

[0023] In some embodiments, the elapsed time measured by the at least one timer is of a longer duration than the second elapsed time measured by the at least one timer.

[0024] In some embodiments, the at least one indicator is configured to generate an indication that the medication is ready for use when a second specified amount of time has elapsed on the at least one timer.

[0025] In some embodiments, the at least one indicator includes at least one of an audio indicator and / or a visual indicator.

[0026] In some embodiments, the visual indicator comprises a first illuminator configured to be activated when the medication is ready to be used.

[0027] In some embodiments, the visual indicator comprises a second illuminator configured to be activated when the medication is not ready for use.

[0028] In some embodiments, the audio indicator is configured to produce a sound when the medication is ready to be used.

[0029] In some embodiments, the indicator comprises a graphical user interface (GUI) on the mobile device configured to indicate when the medication is ready for use.

[0030] In some embodiments, the mobile device is communicatively coupled to one or more of a temperature sensor and a timer.

[0031] In some embodiments, the graphical user interface (GUI) is configured to display an expected duration of the injection based at least in part on the detected temperature and medication.

[0032] In some embodiments, the detector includes a fluid configured to move through a temperature sensor and at least one timer.

[0033] In some embodiments, the detector comprises a user-controlled actuator that, when actuated, is configured to move fluid from a reservoir associated with the user-controlled actuator to the temperature sensor.

[0034] In some embodiments, the temperature sensor comprises a window configured to indicate that the detector is in operation.

[0035] In some embodiments, the fluid is configured to move from the temperature sensor through at least one timer when the pharmaceutical agent reaches or exceeds a bleach temperature.

[0036] In some embodiments, the fluid is configured to travel through at least one timer to at least one indicator for a specified amount of time.

[0037] In some embodiments, the specified amount of time corresponds to when the active pharmaceutical ingredient (API) within the pharmaceutical product is ready for use.

[0038] In some embodiments, the fluid is configured to travel from the temperature sensor through a second timer of the at least one timer when the pharmaceutical agent reaches or exceeds a second bleach temperature.

[0039] In some embodiments, the fluid is configured to travel through a second timer to the at least one indicator for a second specified amount of time.

[0040] In some embodiments, the second bleaching temperature is greater than the bleaching temperature described above, and the second specified length of time is greater than the specified length of time described above.

[0041] In some embodiments, a method for indicating that a pharmaceutical product is ready for use is provided, the method including: detecting a temperature of the pharmaceutical product with a temperature sensor; measuring an elapsed time with at least one timer when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a bleach temperature; and generating an indication that the pharmaceutical product is ready for use with at least one indicator when a specified amount of time has elapsed on the at least one timer.

[0042] In some embodiments, the specified amount of time is selected to correspond to when the active pharmaceutical ingredient (API) within the pharmaceutical product is ready for use.

[0043] In some embodiments, the specified amount of time is selected to correspond to the amount of time it takes for an active pharmaceutical ingredient (API) contained within the pharmaceutical product to reach the desired temperature when placed in an environment within standard room temperature range.

[0044] In some embodiments, the bleaching temperature corresponds to a temperature outside the standard refrigeration temperature range.

[0045] In some embodiments, the method includes activating the temperature sensor with a user-controlled actuator.

[0046] In some embodiments, the method includes measuring, with at least one timer, a second elapsed time when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a second bleach temperature.

[0047] In some embodiments, the second bleaching temperature is higher than the bleaching temperature described above.

[0048] In some embodiments, a first timer of the at least one timer is configured to measure an elapsed time when a bleach temperature is detected, and a second timer of the at least one timer is configured to measure a second elapsed time when a second bleach temperature is detected.

[0049] In some embodiments, the elapsed time measured by the at least one timer is of a longer duration than the second elapsed time measured by the at least one timer.

[0050] In some embodiments, the method includes generating, using the at least one indicator, an indication that the medication is ready for use when a second specified amount of time has elapsed on the at least one timer.

[0051] In some embodiments, the at least one indicator includes at least one of an audio indicator and / or a visual indicator.

[0052] In some embodiments, the method includes activating at least one visual indicator when the medication is ready for use.

[0053] In some embodiments, the method includes activating a second visual indicator of the at least one visual indicator when the medication is not ready for use.

[0054] In some embodiments, the method includes activating an audio indicator to produce a sound when the medication is ready to be used.

[0055] In some embodiments, the method includes indicating on a graphical user interface (GUI) on the mobile device that the medication is ready for use.

[0056] In some embodiments, the mobile device is communicatively coupled to one or more of a temperature sensor and a timer.

[0057] In some embodiments, the method includes displaying an expected duration of the injection on a graphical user interface (GUI) based at least in part on the detected temperature and the medication.

[0058] In some embodiments, the method includes the fluid being configured to move through a temperature sensor and at least one timer.

[0059] In some embodiments, the method includes using a user-controlled actuator to move fluid from a reservoir associated with the user-controlled actuator to a temperature sensor.

[0060] In some embodiments, the fluid travels from the temperature sensor through at least one timer when the pharmaceutical reaches or exceeds a bleach temperature.

[0061] In some embodiments, the fluid travels through at least one timer to at least one indicator for a specified amount of time.

[0062] In some embodiments, the specified amount of time corresponds to when the active pharmaceutical ingredient (API) within the pharmaceutical product is ready for use.

[0063] In some embodiments, the fluid travels from the temperature sensor through a second timer of the at least one timer when the pharmaceutical agent reaches or exceeds a second bleach temperature.

[0064] In some embodiments, the fluid travels through a second timer to the at least one indicator for a second specified amount of time.

[0065] In some embodiments, the second bleaching temperature is greater than the bleaching temperature described above, and the second specified length of time is greater than the specified length of time described above.

[0066] In some embodiments, a detector configured to be attached to a pharmaceutical product containing an active pharmaceutical ingredient (API) therein is provided, the detector comprising: a temperature sensor configured to detect a temperature of the pharmaceutical product; at least one processor configured to calculate a change between the detected temperatures over time; and at least one indicator configured to generate an indication that the pharmaceutical product is ready for use when the change in the calculated change between the detected temperatures over time meets or falls below a predetermined threshold.

[0067] In some embodiments, the predetermined threshold is selected to correspond to when an active pharmaceutical ingredient (API) within a pharmaceutical product is ready for use.

[0068] In some embodiments, calculating the change between the detected temperatures over time includes determining a difference between a first temperature and a second temperature, the first temperature and the second temperature being detected a predetermined amount of time apart.

[0069] In some embodiments, the at least one processor is configured to generate a ratio of a difference between the first temperature and the second temperature separated by a predetermined amount of time and compare the ratio to a predetermined threshold.

[0070] In some embodiments, a method for indicating that a pharmaceutical product is ready for use is provided, the method including: detecting a temperature of the pharmaceutical product using a temperature sensor; calculating, using at least one processor, a change between the detected temperatures over time; and generating, using at least one indicator, an indication that the pharmaceutical product is ready for use if a change in the calculated change between the detected temperatures over time meets or is below a predetermined threshold.

[0071] In some embodiments, the predetermined threshold is selected to correspond to when an active pharmaceutical ingredient (API) within a pharmaceutical product is ready for use.

[0072] In some embodiments, calculating the change between the detected temperatures over time includes determining a difference between a first temperature and a second temperature, the first temperature and the second temperature being detected a predetermined amount of time apart.

[0073] In some embodiments, the at least one processor generates a ratio of the difference between the first temperature and the second temperature separated by a predetermined amount of time and compares the ratio to a predetermined threshold.

[0074] In some embodiments, a liquid crystal sensor is provided that is configured to be attached to a pharmaceutical product that contains an active pharmaceutical ingredient (API), the liquid crystal sensor comprising: liquid crystals configured to change color to indicate an increase in temperature of the pharmaceutical product as the pharmaceutical product warms; and at least one indicator configured to indicate when the API in the pharmaceutical product has reached a specified temperature or temperature range, which indicates when the pharmaceutical product is ready for use.

[0075] In some embodiments, a portion of the liquid crystal is adjacent to at least one indicator on the liquid crystal sensor and is configured to change color when the medication is ready to be used.

[0076] In some embodiments, the liquid crystal comprises a visual meter that indicates the temperature of the medication increasing as the medication warms.

[0077] In some embodiments, at least one indicator corresponds to an end of a visual meter.

[0078] In some embodiments, the at least one indicator is configured to indicate an expected duration of the injection.

[0079] In some embodiments, any one or more of the features, characteristics, or elements discussed above with respect to any of the embodiments may be incorporated into any of the other embodiments mentioned above or described elsewhere herein. [Brief explanation of the drawings]

[0080] [Figure 1] 1 illustrates a medication having a detector disposed thereon for detecting the temperature of the medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 2A] FIG. 1 shows a system diagram of a detector for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 2B] 1 illustrates an exemplary detector for indicating when a medication is ready to be used, according to some embodiments. [Figure 2C] 1 illustrates an exemplary detector for indicating when a medication is ready to be used, according to some embodiments. [Figure 2D] 1 illustrates an exemplary graphical user interface (GUI) of a personal computing device for indicating when a medication is ready to be used, according to some embodiments. [Figure 2E] 1 illustrates an exemplary printed circuit board (PCB) of a detector for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 2F] 1 shows a schematic diagram of a detector for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 3] 1 shows a plot of the time it takes for the exterior surface of a pharmaceutical casing and the liquid contained within the casing to warm to room temperature (eg, 21.7° C.), according to some embodiments. [Figure 4A]1 illustrates a detector comprising a fluid and one or more substrates for detecting the temperature of a pharmaceutical product and indicating when the pharmaceutical product is ready to be used, according to some embodiments. [Figure 4B] 1 illustrates a detector comprising a fluid and one or more substrates for detecting the temperature of a pharmaceutical product and indicating when the pharmaceutical product is ready to be used, according to some embodiments. [Figure 4C] 1 illustrates a detector comprising a fluid and one or more substrates for detecting the temperature of a pharmaceutical product and indicating when the pharmaceutical product is ready to be used, according to some embodiments. [Figure 4D] 1 illustrates a detector comprising a fluid and one or more substrates for detecting the temperature of a pharmaceutical product and indicating when the pharmaceutical product is ready to be used, according to some embodiments. [Figure 4E] 1 illustrates a detector comprising a fluid and one or more substrates for detecting the temperature of a pharmaceutical product and indicating when the pharmaceutical product is ready to be used, according to some embodiments. [Figure 5A] 1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 5B] 1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 5C] 1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 5D] 1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 5E] 1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 5F] 1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 5G]1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 5H] 1 illustrates a liquid crystal sensor for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. [Figure 6] 1 illustrates a method for detecting the temperature of a medication and indicating when the medication is ready to be used, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0081] Described herein are detectors configured to be attached to a pharmaceutical product and detect the temperature of the pharmaceutical product and indicate whether the pharmaceutical product is ready for use based on a specified amount of time elapsed. The disclosed detectors can detect when the pharmaceutical product reaches a bleach temperature and indicate whether the pharmaceutical product is ready for use based on a specified amount of time elapsed since reaching or exceeding the bleach temperature. A bleach temperature can be defined as a temperature outside of a standard refrigeration range (e.g., 2°C to 8°C). In some embodiments, the bleach temperature can be between 10°C and 15°C (e.g., 12°C). Based on the pharmaceutical product reaching one or more bleach temperatures, the detector can start a timer configured to measure the elapsed time and indicate that the pharmaceutical product is ready for use after the specified amount of time has elapsed.

[0082] Traditionally, users may refer to the instructions for use (IFU) accompanying a drug product (e.g., on the product label and / or package insert) to determine how and when to use the drug product. Additionally, a medical professional may provide instructions for use of the drug product to the user verbally during a medical visit and / or in a written medical note. The instructions may include a waiting time required before using the drug product. The waiting time may be defined as the duration that a drug product stored in a controlled, refrigerated environment (e.g., a refrigerator, a freezer, etc.) is required to rest in an ambient environment (e.g., standard room temperature, approximately 20°C to 22°C) before use. The waiting time may be required to allow the drug product's API to warm to ambient temperature, thus reducing the API's viscosity and preparing the API for proper injection. The instructions may also include a maximum duration that should not be exceeded while the drug product is resting in an ambient environment. The API may expire after a predetermined duration (e.g., 4 to 8 hours) outside of a controlled, refrigerated environment, thus rendering the API unsafe for use.

[0083] These instructions are often forgotten, misplaced, confused (e.g., with another medication), or ignored (e.g., if the user is in a hurry) during medication use. Users may attempt to use the medication immediately after it is removed from the refrigerated environment, and if the medication requires injection, failure to adhere to the waiting time may result in prolonged injection times, failed medication injection, and / or at least pain at the injection site. Each of these problems may be due to at least the low temperature and therefore high viscosity of the API. Injection time can be defined as the duration required to fully inject the medication into the user. In some cases, users may forget to track time after removing the medication from the controlled refrigerated environment and leave the medication in the ambient environment for a duration that exceeds the maximum duration the medication can be left outside the refrigerated environment. In this case, the medication may lose its efficacy and / or expire, thus rendering the medication unsuitable and unsafe for use.

[0084] In some cases, despite a user's scrutiny of the recommended waiting time provided in the IFU and / or communicated by a medical professional, the drug product may require more or less time to reach the appropriate temperature for use. This variability in time to reach the appropriate temperature for use may be due, at least in part, to fluctuations in room temperature where the drug product is required to stand before use. In certain instances, the drug product may never reach the appropriate temperature for use. Currently, there is no way for a user to know that the drug product is ready for use sooner than the recommended waiting time or that additional standing time is required before use. The detectors described herein detect the temperature of the drug product and activate one or more timers based on the detection of at least one bleach temperature. The timers may be configured using various algorithms to indicate when the drug product is ready for use based on the elapsed time and / or the temperature reached. The provided detectors can more efficiently and effectively inform the user when the drug product is ready for use, reducing any risk of user confusion and improving user compliance with waiting times associated with the active pharmaceutical ingredient (API).

[0085] The detectors described herein may include a temperature sensor, at least one timer, and at least one indicator. In some embodiments, the temperature sensor may detect the temperature of the pharmaceutical product, and a first timer may begin measuring an elapsed time when the temperature sensor detects that the pharmaceutical product has reached or exceeded a bleach temperature. In some embodiments, the second detector may be configured to measure a second elapsed time when the temperature sensor detects that the pharmaceutical product has reached a second bleach temperature. The at least one indicator may generate an indication that the pharmaceutical product is ready for use when a specified amount of time measured by either the first timer or the second timer has elapsed. In some embodiments, the detector may need to be activated by a user to begin detecting the temperature of the pharmaceutical product. In some embodiments, the indicator may include one or more illuminators configured to illuminate when the pharmaceutical product is not ready for use and when the pharmaceutical product is ready for use. In some embodiments, the sensor may be communicatively coupled to a personal computing device (e.g., a desktop, tablet, mobile device, smartwatch, etc.) and indicate to a user when the pharmaceutical product is / is not ready for use.

[0086] In some embodiments, the detector may include a fluid that moves through one or more fluid paths (e.g., a timer) when the temperature of the fluid reaches or exceeds one or more bleach temperatures. The fluid may move through one or more fluid paths to an indicator for a specified length of time to indicate that the medication is ready for use. In some embodiments, the detector may need to be activated by a user for the fluid to move to the temperature sensor.

[0087] In some embodiments, the detector may be embodied in a liquid crystal sensor comprising a liquid crystal that may be configured to change color based on the increasing temperature of the pharmaceutical product to indicate whether the pharmaceutical product is ready for use after an elapsed time.

[0088] The detectors described herein may be associated with various pharmaceutical products. For example, pharmaceutical products may include drug delivery devices (e.g., auto-injectors, syringes, etc.), nasal sprays, inhalers, eyedroppers, or containers (e.g., vials, bottles, cartridges, etc.) that contain or are configured to contain active pharmaceutical ingredients (APIs) (e.g., pharmaceuticals, drugs, antibiotics, vaccines, medications, etc.). Injection devices may include syringes (e.g., hypodermic syringes, oral delivery syringes, pre-filled syringes, glass syringes, plastic syringes, etc.), on-body delivery systems (OBDS), patch pumps, automatic injection systems (e.g., pumps, patch pumps, and pens), manual injection systems, syringe pumps, etc.

[0089] In some embodiments, the medication may be provided with a detector attached to the medication. In some embodiments, the user may be required to attach the detector to the medication before using the medication. In some embodiments, the detector and medication may be single-use and disposable. In some embodiments, the detector may be reusable. In some embodiments, the medication may include an API contained in a container (e.g., a vial, bottle, cartridge, etc.), and the user may remove the API from the container using an injection device when a detector associated with the container indicates that the medication is ready to be used.

[0090] In some embodiments, the active pharmaceutical ingredient (API) may require storage in a refrigerated environment (e.g., refrigerator, freezer, etc.) until use. Exemplary APIs may include eye / ear drops, reconstituted antibacterial agents, injectables, and other large molecule drugs (e.g., nipocalimab) in liquid form.

[0091] The list of APIs provided above is not intended to be exhaustive and may be extended to any pharmaceuticals, drugs, medications, antibiotics, vaccines, etc. not expressly mentioned herein. One of skill in the art will be able to reasonably apply the detectors disclosed herein to a variety of containers, syringes, etc. and various pharmaceutical products containing APIs contained therein.

[0092] Referring now to the drawings, like parts are designated throughout the specification and drawings with the same reference numerals, respectively.

[0093] Medications for use with the detector The detectors disclosed herein can be configured to be attached to a variety of pharmaceutical products containing active pharmaceutical ingredients (APIs).

[0094] FIG. 1 illustrates an exemplary pharmaceutical product having a detector 100 attached thereto. The pharmaceutical product 102 may include, for example, a drug delivery device, a nasal spray, an inhaler, an eye dropper, a container, or another vessel for housing an API. As described above, exemplary drug delivery devices may include injection devices such as syringes (e.g., hypodermic syringes, oral delivery syringes, prefilled syringes, glass syringes, plastic syringes, etc.), on-body delivery systems (OBDS), patch pumps, automatic injection systems (e.g., pumps, patch pumps, and pens), manual injection systems, syringe pumps, etc. In some embodiments, exemplary containers may include vials, bottles, cartridges, etc. Hereinafter, the containing portion of the pharmaceutical product (e.g., drug delivery device, container, etc.) may be referred to as a "container."

[0095] In some embodiments, detector 100 may be configured within the packaging of pharmaceutical product 102. In some embodiments, detector 100 may be configured on an exterior portion of the packaging of pharmaceutical product 102. In some embodiments, at least a portion of detector 100 may be configured within a reservoir of pharmaceutical product 102 such that detector 100 may be in physical contact with the API contained within the pharmaceutical product. In embodiments in which at least a portion of detector 100 (e.g., a temperature sensor) is not in contact with the API of the pharmaceutical product, one or more algorithms may be configured to extrapolate the temperature of the API based on the temperature of the container, packaging, etc.

[0096] For example, detector 100 may be configured to detect the temperature of the exterior surface of pharmaceutical product 102 to determine the temperature of the API contained within the container, as described in more detail with respect to at least FIG. 3. In some embodiments, detector 100 may be attached to the packaging of the pharmaceutical product or to the exterior surface of the pharmaceutical product and configured to detect the temperature of the environment (e.g., air) immediately surrounding the pharmaceutical product to determine the temperature of the API. In some embodiments, detector 100 may be attached to and configured to detect the temperature of a container comprising one or more materials, such as glass and polymers (e.g., polyvinyl chloride, polystyrene, polypropylene, polyethylene, polyester, nylon, polyvinylidene chloride, polycarbonate, etc.). Because many of these materials can be insulators, through experimentation and / or algorithms, the temperature of the API within the container may be determined by considering the characteristics of heat transfer between the container, the environment, and the API, as described in more detail below.

[0097] One or more of the detector 100 and the container of the pharmaceutical product 102 may include an adhesive material so that the detector 100 can be adhered to the pharmaceutical product 102, for example, by a user and / or before providing the pharmaceutical product to the user. In some embodiments, the pharmaceutical product 102 and the detector 100 may be manufactured and / or provided as a single unit such that the detector 100 is not configured to be removable from the pharmaceutical product 102. In some embodiments, the detector 100 may be provided on a removable sleeve, the sleeve configured to attach around at least a portion of the pharmaceutical product 102. In some embodiments, as described above, the pharmaceutical product 102 may be single-use and disposable. Similarly, the detector 100 may be single-use and disposable. In some embodiments, each of the detector 100 and / or pharmaceutical product 102 may be reusable and / or semi-reusable. For example, a user may adhere a single reusable detector 100 to a different single-use pharmaceutical product 102 every day (or every few hours, every few days, every few months, etc.).

[0098] Detector 100 may be embodied in an electrical system, a fluid-based system, or a liquid crystal sensor system, each of which is described in more detail below with respect to Figures 2A-2F, 4A-4E, and 5A-5H.

[0099] Electrical detectors for pharmaceuticals 1 may be embodied in an electrical detection system that includes one or more electrical components (e.g., one or more processors, temperature sensors, illuminators, etc.) communicatively coupled (e.g., via wired and / or wireless communication) to detect the temperature of the pharmaceutical product, measure the elapsed time when one or more bleach temperatures are reached or exceeded, and indicate when the pharmaceutical product is ready for use based on the elapsed time. Figures 2A-2F illustrate features of an electrical detector configured to detect the temperature of the pharmaceutical product and indicate whether the pharmaceutical product is ready for use based on a specified elapsed time, according to some embodiments.

[0100] 2A shows a system diagram of a detector 200 configured to detect the temperature of a medication and indicate when the medication is ready to be used. Detector 200 may include any one or more features of detector 100 described above with respect to FIG. 1. Detector 200 may include a user-controlled actuator 204, a temperature sensor 206, an illuminator (e.g., a light indicator) 208, a speaker 210, a processor 212, a memory 214, and a power source (e.g., a battery) 216. Each of the illustrated components of detector 200 may be embodied by two or more components. For example, detector 200 may include multiple processors 212, temperature sensors 206, illuminators 208, etc. In some embodiments, each of the components of detector 200 may be communicatively coupled to one another such that each component may transmit signals to and / or receive signals from other components of detector 200. In some embodiments, each of the components may be communicatively coupled to at least one or more processors 212 such that the processors 212 are configured to receive signals from each of the components of the detector 200 and to send one or more signals to the components of the detector 200 to perform actions based on the received signals.

[0101] In some embodiments, based on the received signal, processor 212 may be configured to activate and / or deactivate one or more components (e.g., temperature sensor 206, illuminator 208, and / or speaker 210) indicated on detector 200. In some embodiments, processor 212 may include at least one timer configured to measure an elapsed time (e.g., once a bleach temperature is detected by temperature sensor 206). The timer, in some embodiments, may measure a time that starts at zero and counts down to a predetermined time. In some embodiments, the timer may measure a time that starts at a predetermined time and counts down to zero. In some embodiments, the timer is a separate component communicatively coupled to at least processor 212 and / or one or more components (e.g., temperature sensor 206) of detector 200. In some embodiments, processor 212 may include multiple timers configured to measure different elapsed times to indicate when the medication is ready to be used after a specified amount of time has elapsed. In some embodiments, the processor 212 may include one or more memories, such as memory 214 (eg, the memory 214 may reside within the processor 212).

[0102] As shown in FIG. 2A , the detector 200 may include a user-controlled actuator 204. The user-controlled actuator 204 may include one or more touch-sensitive buttons, switches, capacitive touch sensors, pressure sensors, etc. configured to receive user input indicating a request to activate (e.g., turn on) the detector 200. For example, FIG. 2B illustrates the detector 200 with the user-controlled actuator 204, which may be a touch-sensitive button. In some embodiments, the user-controlled actuator 204 may be configured to send a signal (e.g., directly and / or indirectly via the processor 212) to one or more components of the detector 200 (e.g., the temperature sensor 206, the illuminator 208, and / or the speaker 210) upon receiving the user input. For example, the user-controlled actuator 204 may be configured to receive the user input and send a signal to the temperature sensor 206 to activate the temperature sensor 206 and begin detecting the temperature of the medication. In some embodiments, the user-controlled actuator 204 may alternatively or additionally send a signal to the processor 212, which may send a signal to the temperature sensor 206 to activate the sensor. The user may engage (e.g., tap, push, etc.) the user-controlled actuator 204 for a specified amount of time (e.g., 1, 2, 3 seconds) to activate the detector 200. In some embodiments, in response to a user activating the detector 200 via the user-controlled actuator 204, a light indicator (e.g., illuminator 220 in FIG. 2B ) may be configured to illuminate (e.g., based on a signal received from the user-controlled actuator 204 and / or the processor 212). The illuminator may communicate, for example, that the detector 200 is operational (e.g., detecting at least the temperature of the pharmaceutical product) but is not yet ready for use.

[0103] In some embodiments, the detector 200 may include one or more temperature sensors 206. The temperature sensor 206 may be configured to continuously detect the temperature of the pharmaceutical product (e.g., the pharmaceutical product 102 described above with respect to FIG. 1 ). In some embodiments, the temperature sensor 206 may be disposed within the detector 200 such that at least a portion of the temperature sensor 206 is adjacent to and / or in contact with an exterior surface of the pharmaceutical product. As described above, in some embodiments, the temperature sensor 206 may be disposed on the pharmaceutical product packaging and / or configured to measure the temperature of the pharmaceutical product packaging. In some embodiments, the temperature sensor 206 may be disposed within the pharmaceutical product to directly detect the temperature of the API. In some embodiments, the temperature sensor 206 may be configured to detect the temperature of the environment (e.g., air) immediately surrounding the pharmaceutical product. The temperature sensor 206 may include one or more thermocouples, resistance temperature detectors (RTDs), thermistors (e.g., negative temperature coefficient (NTC) thermistors), and / or semiconductor-based integrated circuits (ICs). For example, the temperature sensor 206 may include an NTC thermistor, such that the resistance of the thermistor decreases as the temperature increases. In some embodiments, the thermistor may include a polymeric material or a ceramic material. The temperature sensor 206 may be communicatively coupled to one or more components of the detector 200. For example, the temperature sensor 206 may be configured to receive input (e.g., a signal) from the user-controlled actuator 204 (e.g., directly and / or indirectly via the processor 212). For example, as described above, the user-controlled actuator 204 may send a signal to the temperature sensor 206, and the temperature sensor 206 may operate based on the received signal.

[0104] In some embodiments, the temperature sensor 206 may be configured to send and receive signals to the processor 212. For example, the temperature sensor 206 may continuously detect the temperature of the medication as it warms up to an appropriate use temperature (e.g., toward ambient temperature). For each detected temperature, the temperature sensor 206 may send a signal indicative of the detected temperature to the processor 212. The processor 212 may determine when the medication is ready for use based on the detected temperature and / or elapsed time, as described in more detail below.

[0105] In some embodiments, upon detecting a bleach temperature of the pharmaceutical product, the temperature sensor 206 may be configured to activate one or more timers (e.g., directly and / or indirectly via the processor 212). The bleach temperature of the pharmaceutical product may be a temperature outside the standard refrigeration range (e.g., 2°C to 8°C), as defined above. In some embodiments, the bleach temperature may be 10°C to 15°C (e.g., 12°C), and thus, minor fluctuations in temperature above the standard refrigeration range for a short period of time may not be classified as a bleach temperature. In some embodiments, the initial temperature detected by the temperature sensor 206 may be the bleach temperature. In some embodiments, the value of the bleach temperature may be stored in a temperature library in the memory 214, allowing the processor 212 to retrieve temperature data from the memory 214 and classify the signal as corresponding to the detected bleach temperature.

[0106] In some embodiments, the timer may measure the elapsed time after the detection of the bleach temperature for a specified length of time. The specified length of time may be based on one or more factors, such as the material of the pharmaceutical container, the detected ambient room temperature, and / or the API contained in the container. For example, the memory 214 may be configured to store a library of specific times associated with different pharmaceutical containers, APIs, and room temperatures. The system may be configured to select the specific length of time, for example, using at least the detected temperature of the container to determine the room temperature, as described in more detail below. In some embodiments, as described above, the timer of the processor 214 may be configured to count from zero to a specified time. In some embodiments, the timer may be configured to count down from a specified time toward zero.

[0107] In some embodiments, the temperature sensor 206 may continue to detect the temperature of the pharmaceutical product following detection of the bleach temperature. In some embodiments, the temperature sensor 206 may detect a second bleach temperature that is higher than the first bleach temperature. Based on the second bleach temperature, the temperature sensor 206 may be configured (e.g., directly or indirectly via the processor 212) to cause a timer to measure a second elapsed time. In some embodiments, the second elapsed time may be shorter than the first elapsed time. In some embodiments, the detector 200 may include two or more timers (e.g., two, three, four, five, or more timers) configured to measure respective elapsed times of the subject (e.g., optionally embodied within the processor 212). In some embodiments, rather than measuring the second elapsed time based on the second detected bleach temperature, the processor 212 may be configured to modify the specified length of time that the timer is counting. For example, the processor 212 may shorten the time that the timer is counting if the timer is counting from zero. In some embodiments, the processor 212 may reduce the current time of the timer based on the second detected bleach temperature if the timer started counting time from a predetermined value associated with the first bleach temperature and / or pharmaceutical.

[0108] For example, detector 200 may be configured to indicate that the medication is not ready for use if the detected temperature is below the bleach temperature (e.g., 15°C in this example). When temperature sensor 206 detects a temperature of 15°C or greater, processor 212 may be configured to initiate a first elapsed time measurement. For example, a timer may measure a 30-minute elapsed time such that the medication is ready for use after 30 minutes have elapsed. In some embodiments, temperature sensor 206 may continue to detect the temperature of the medication after the first timer begins measuring the elapsed time. When temperature sensor 206 detects a second bleach temperature (e.g., 18°C ​​in this example), processor 212 may be configured to initiate a second elapsed time measurement. For example, based on the second bleach temperature, the timer may be configured to measure a 5-minute elapsed time. Detector 200 may be configured to notify the user that the medication is ready for use when either the first elapsed time or the second elapsed time has elapsed (e.g., whichever occurs first).

[0109] In some embodiments, detector 200 may include a third timer configured to measure elapsed time regardless of the detected bleach temperature. For example, the third timer may be configured to measure elapsed time when detector 200 is activated and may indicate that the pharmaceutical product is ready for use after a predetermined amount of time has elapsed.

[0110] In some embodiments, in addition to or instead of measuring the elapsed time after reaching and / or exceeding the bleach temperature, processor 212 may be configured to determine the relationship between the elapsed time and the detected temperature to determine whether the pharmaceutical product is ready for use. For example, processor 212 may determine when the pharmaceutical product is ready for use by continuously tracking the temperature change of the pharmaceutical product over time. Processor 212 may analyze the rate of temperature change over time, and if processor 212 detects a low, stable ratio (e.g., less than 1), processor 212 may cause one or more indicators (described in more detail below) to indicate that the pharmaceutical product is ready for use. For example, processor 212 may continuously compare two temperatures detected a predetermined duration (e.g., 1 minute) apart to determine a ratio (e.g., second temperature - first temperature / 1 minute). In some embodiments, processor 212 may compare two temperatures detected a shorter duration (e.g., 15, 30, 45 seconds, etc.) or a longer duration (e.g., 2, 3, 4 minutes, etc.) apart. Based on the relationship between temperature and time, the processor 212 may be able to determine when the pharmaceutical product has equilibrated to an appropriate use temperature (eg, ambient temperature) and is ready to be used.

[0111] FIG. 2F shows an exemplary schematic diagram with one or more logic gates for determining when a medication is ready to be used, according to at least the above algorithm. For example, when a user engages a user-controlled actuator (e.g., a switch) 204, a timer 224 may be configured to begin measuring elapsed time, and a temperature sensor 206 (e.g., a negative temperature coefficient (NTC) thermistor) may simultaneously begin detecting the temperature of the medication. The timer 224 (e.g., optionally embodied within the processor 212) and the temperature sensor 206 may transmit signals indicative of the measured time and detected temperature, respectively. Based on the received signals, the processor (e.g., a computer processing unit (CPU)) 212 may be configured to analyze the change in temperature. As shown in FIG. 2F, based on the analysis, the processor 212 may transmit a signal to one or more logic gates 226 communicatively coupled to one or more indicators. For example, when the temperature change is greater than 1, the processor 212 may send an “off” (e.g., binary 0) signal to a “NOT” logic gate 226 (e.g., configured to perform the opposite of a received signal) communicatively coupled to the illuminator (e.g., an LED light indicator) 220. As described in more detail below, the illuminator 220 may be configured to indicate to a user when the medication is not ready for use. The processor 212 may also (e.g., substantially simultaneously) send an “off” signal to an “AND” logic gate. The “AND” logic gate may receive input from additional components of the detector 200 configured to determine when the detector 200 is stabilized. For example, upon activation of the detector 200 by the user-controlled actuator 204, a second timer may be configured to begin measuring a predetermined elapsed time (e.g., at least 1 minute). Once the predetermined elapsed time has elapsed, a switch may be activated such that a signal may be sent to the “AND” logic gate. When the two signals (eg, binary 1) from the components match, an illuminator (eg, LED light indicator) 208 communicatively coupled to the "AND" logic gate may be activated.In some embodiments, when the temperature change is less than 1, the processor 212 may send an "on" (e.g., binary 1) signal to the logic gate 226. A "NOT" logic gate may send a signal to the illuminator 220, turning the illuminator off. On the other hand, an "AND" logic gate, upon receiving two matching signals (e.g., binary 1), may send a signal to one or more indicators (e.g., the illuminator 208, the speaker 210) indicating that the medication is ready for use.

[0112] In some embodiments, the processor 212 may use the initial temperature of the environment outside of the controlled cooling environment (e.g., once the medication is removed from the refrigerator) to determine when the medication is ready to be used. For example, the temperature sensor 206 may detect the temperature of the medication during an initial stabilization period that occurs upon activation of the detector 200 (e.g., via the user-controlled actuator 204). The initial stabilization period may be of a predetermined duration (e.g., 1 minute, 90 seconds, 2 minutes, etc.). For example, the temperature sensor 206 may detect a first temperature at the time of activation (time1=0) and a second temperature at a predetermined time point after the activation time (e.g., time2=0.7). * The second temperature may be detected at a predetermined time constant (time constant), where the predetermined time is based on the calculated time constant of the detector 200. The time constant of the detector 200 may be determined experimentally by measuring the temperature change of the pharmaceutical product detected by the detector 200 and noting the point at which, for example, 63% settling occurs. Using the first detected temperature and the second detected temperature, the processor 212 of the detector 200 may estimate the ambient temperature (e.g., room temperature). For example, the relationship between the estimated ambient temperature and the detected first and second temperatures may be embodied in the following equation: T ambient =T1+2(T2-T1) Equation 1. Estimated Ambient Temperature

[0113] In some embodiments, the relationship between the first temperature and the second temperature for determining the ambient room temperature may be different from that provided above in Equation 1. In some embodiments, one or more of the estimated ambient temperature, the first temperature, and the second temperature may be stored, for example, in a memory (e.g., a temporary memory of the processor 212, the memory 214, etc.). Based on the estimated ambient temperature, the processor 212 may determine a target temperature (e.g., a temperature at which the pharmaceutical product is ready to be used) and / or a maximum wait time (e.g., a maximum time required to wait before using the pharmaceutical product). In some embodiments, the target temperature may be a portion (e.g., 90%, 95%, 98%, or another specified value) of the estimated ambient temperature. In some embodiments, the maximum wait time may additionally or alternatively be based on the type of API in the container, the material of the container, the volume of the API, etc. For example, as described above, the processor 212 may access a memory 214 that stores a target temperature associated with the determined ambient temperature and a maximum wait time associated with the determined wait time and one or more of the one or more factors provided above.

[0114] In some embodiments, the processor 212 may initiate a measurement of elapsed time (e.g., limited by a maximum wait time) in response to determining the estimated ambient temperature. In some embodiments, the maximum wait time may be independent of the estimated room temperature, such that a timer in the processor 212 initiates a measurement of elapsed time (limited by a predetermined maximum wait time) upon activation of the detector 200. The temperature sensor 206 may be configured to periodically detect the temperature of the pharmaceutical product over time (e.g., at least every 5, 10, 20, 30, or 60 seconds) once the target temperature is determined. The processor 212 may be configured to receive a signal indicative of the detected temperature from the temperature sensor 206 and may compare the detected temperature to the target temperature. In some embodiments, the processor 212 may be configured to activate one or more indicators when a temperature equal to or greater than the target temperature is detected or when the maximum wait time is reached, whichever occurs first.

[0115] In some embodiments, the processor 212 may be configured, upon activation of the detector 200 (e.g., via the user-controlled actuator 204), to measure the elapsed time until the detection of a bleach temperature (e.g., 12°C, 15°C, or another predetermined temperature). Based on the time elapsed to reach the bleach temperature, the processor 212 may determine the ambient temperature (e.g., room temperature) and / or the time required for the pharmaceutical product to reach an appropriate use temperature. For example, as described above, the temperature sensor 206 may periodically detect the temperature of the pharmaceutical product and compare the detected temperature to a determined appropriate use temperature to identify whether the pharmaceutical product is ready for use. In some embodiments, the temperature sensor 206 may activate one or more timers (e.g., embodied within the processor 212) to measure the elapsed time based on the determined time required for the pharmaceutical product to reach an appropriate use temperature.

[0116] In some embodiments, the processor 212 may be configured to measure a specified amount of time upon activation of the detector 200 regardless of the temperature of the environment outside the controlled cooling environment.

[0117] In some embodiments, processor 212 may apply one or more of the methods (e.g., algorithms) described above to determine when a medication is ready for use. For example, processor 212 may use a combination of algorithms to provide an indication that a medication is ready for use when it is determined that the above-described scenarios have occurred (e.g., whichever occurs first may cause the indication).

[0118] In some embodiments, detector 200 may include one or more indicators configured to indicate when the medication is ready for use. As described above, detector 200 may further include one or more indicators (e.g., illuminator 220 shown in FIGS. 2B-2C) configured to indicate when the medication is not ready for use. In some embodiments, the one or more indicators of detector 200 may include illuminator 208 and / or speaker 210. In some embodiments, illuminator 208 may include one or more light emitting diodes (LEDs). In some embodiments, illuminator 208 may be configured to receive a signal transmitted from processor 212, the signal indicating that the medication is ready for use. For example, processor 212 may be configured to transmit a signal to illuminator 208 when a specified amount of time has elapsed, as described above. In some embodiments, processor 212 may be configured to transmit a signal to illuminator 208 upon determining that the appropriate use temperature has been reached (e.g., before the specified amount of time has elapsed). In some embodiments, processor 212 may deactivate an illuminator configured to indicate to a user that the medication is not ready for use (e.g., illuminator 220 of FIGS. 2B-2C) after a specified time has elapsed and / or when an appropriate use temperature has been reached. In some embodiments, illuminator 220 may be configured to be deactivated substantially simultaneously with illuminator 208 being activated.

[0119] In some embodiments, the illuminator 208 may be configured to illuminate for a predetermined duration. For example, the illuminator 208 may illuminate for any duration (e.g., seconds, minutes, or hours) up to a specified length of time (e.g., 4, 5, 6, 7, or 8 hours). In some embodiments, a timer in the processor 212 may measure the time it takes for the medication to be ready for use and may indicate that the medication should not be used after a predetermined duration of readiness (e.g., 4 hours). For example, after the predetermined duration, the illuminator 208 may be deactivated (e.g., neither the illuminator 208 nor the illuminator 220 is activated). In some embodiments, the detector 200 may include an additional indicator (e.g., illuminator 221 in FIG. 2C ) configured to illuminate after a predetermined duration to indicate that the medication has expired. For example, various APIs may be unsafe for use after being left outside a controlled refrigeration environment for a predetermined duration (e.g., 2, 4, 6, or 8 hours). The illuminator 221 may be configured to illuminate after the predetermined duration has elapsed. The duration corresponds to the API of the drug. By turning off illuminator 208 and / or turning on illuminator 221 after a predetermined duration, detector 200 can indicate a time window during which it is safe to use the drug.

[0120] In some embodiments, the illuminator 208 may be communicatively coupled to the user-controlled actuator 204 (e.g., directly or indirectly via the processor 212) such that a user may engage the user-controlled actuator 204 to stop the illuminator 208. In some embodiments, the user may engage the user-controlled actuator 204 to pause and / or power off the detector 200. In some embodiments, the detector 200 may include one or more sensors (not shown) configured to detect when a medication has been used and / or is currently being used, and the illuminator 208 may be configured to stop when it is determined that the medication has been used.

[0121] In some embodiments, illuminator 208 (and / or illuminator 220 shown in FIGS. 2B-2C) may be configured to illuminate continuously and / or flash. For example, the illuminator may flash according to a predetermined pattern corresponding to elapsed time as the medication approaches a ready-to-use state. For example, illuminator 220 may initially flash at a slow rate, and the rate at which the illuminator flashes may increase as the medication reaches the appropriate time and / or temperature for use. In some embodiments, illuminator 220 may initially flash at a fast rate, and the rate may decrease as the medication approaches a ready-to-use state (e.g., based on the measured temperature and / or elapsed time).

[0122] In some embodiments, the detector 200 may include an array of illuminators (e.g., as shown in FIG. 2C ) configured to indicate the status of the pharmaceutical when the pharmaceutical reaches an appropriate temperature and / or time for use. For example, the detector 200 may include at least two, three, four, five, six, seven, or eight illuminators configured to indicate the status of the pharmaceutical (e.g., not ready, ready, and / or expired). In some embodiments, the array of illuminators 220 may be configured to gradually illuminate over time and / or as the temperature of the pharmaceutical approaches an appropriate use temperature. For example, a first illuminator may be activated when the detector 200 is activated, a second illuminator may be activated a specified amount of time after activation of the detector and first illuminator, a third illuminator may be activated a specified amount of time following activation of the second illuminator, and so on, until the corresponding illuminator 208 is activated when the device is ready for use. In some embodiments, the multiple illuminators 220 may be configured to gradually illuminate as a bleach temperature is detected. For example, if a first bleach temperature is detected, a first illuminator may be activated; if a second bleach temperature is detected, a second illuminator may be activated; if a third bleach temperature is detected, a third illuminator may be activated, and so on until an appropriate operating temperature and / or specified time period is reached. In some embodiments, the illuminators may comprise one or more colors (e.g., red, blue, green, white, yellow, etc.). For example, illuminator 208 may illuminate a first color (e.g., green) and illuminator 220 may illuminate a second color (e.g., red) that is different from the first color.

[0123] 2B-2C, each of illuminators 208, 220, and 221 may correspond to a text label and / or icon on detector 200 to indicate whether the medication is ready for use. For example, detector 200 may include a label adjacent illuminator 220 configured to indicate that detector 200 is operational but the medication is not yet ready for use (e.g., "Not Ready for Use," "Not Ready," "Operating," "On," etc.). Similarly, detector 200 may further include a label adjacent illuminator 208 configured to indicate that the medication is ready for use (e.g., "Ready for Use," "Ready," etc.). Detector 200 may also include a label adjacent illuminator 221 (e.g., "Expired," "Elapsed," etc.) configured to indicate that the medication has expired, for example, due to reaching or exceeding an allotted maximum time outside of a controlled cooling environment.

[0124] In some embodiments, in addition to or instead of activating the illuminator 208, the processor 212 may send a signal to the speaker 210 configured to indicate that the medication is ready to be used. In some embodiments, the speaker 210 may comprise a multi-tone and / or piezoelectric sounder (e.g., a buzzer). The speaker 210 may generate an audible sound (e.g., a tone, an alarm, a noise, etc.) in response to receiving a signal from the processor 212. In some embodiments, the speaker 210 may generate a continuous or discontinuous (e.g., a beep pattern) sound. In some embodiments, the speaker 210 may be configured to generate a sound for a predetermined duration. For example, the speaker 210 may generate a sound for 5, 10, 15, 20, 25, or 30 seconds or less. In some embodiments, the speaker 210 may generate a noise for 5, 10, 15, 20, 25, or 30 seconds or more. In some embodiments, speaker 210 may be communicatively coupled (e.g., directly or indirectly via processor 212) to user-controlled actuator 204 such that a user may engage user-controlled actuator 204 to deactivate speaker 210. In some embodiments, detector 200 may include one or more sensors (not shown) configured to determine when a medication has been used and / or is currently being used, and based on a determination that the medication has been used, speaker 210 may be configured to deactivate. In some embodiments, detector 200 may include one or more volume controllers (not shown) such that a user may control the volume of the sound produced by speaker 210.

[0125] As shown in FIG. 2A , the detector 200 may be communicatively coupled to a personal computing device 218 via wireless communication (e.g., WiFi, Bluetooth, Zigbee, etc.) to indicate when the medication is ready for use. The personal computing device 218 may include a mobile device, tablet, desktop, smartwatch, etc. In some embodiments, the detector 200 may include one or more processors configured to send and / or receive signals from the personal computing device 218 (i.e., separate from the processor 212, which may be configured to send and / or receive signals from components within the detector 200). FIG. 2D shows an exemplary mobile computing device 218 having a graphical user interface (GUI) 222. As shown, the GUI 222 of the mobile computing device 218 may be configured to indicate when the medication is ready for use. In some embodiments, the GUI 222 may be configured to indicate when the medication is not ready for use. The GUI 222 may provide a detected temperature (e.g., the temperature of a container) when the medication is / is not ready for use. In some embodiments, the mobile computing device 218 may be configured to generate a notification when the medication is ready to be used (e.g., based on the temperature and / or age of the medication). For example, the mobile computing device 218 may generate a notification (e.g., a sound, vibration, text notification, etc.) when the medication is ready to be used, even though the mobile computing device is not currently displaying the GUI 222. In some embodiments, the GUI 222 may further provide the user with information related to the API (e.g., the type and / or dosage of the API, the expiration date, etc.).

[0126] In some embodiments, the GUI 222 can display an expected injection time. The injection time may be defined as the expected duration for injecting the API, for example, if the medication includes an auto-injector. The injection time may be dynamically updated (e.g., decreased), for example, as the auto-injector injects the API into the user. In some embodiments, the processor 212 may include one or more sensors configured to detect when the auto-injector begins and / or finishes an injection, and this data may be transmitted to the mobile computing device 218 for display on the GUI 222. In some embodiments, the auto-injector may experience a plunger delay (e.g., the time difference between the detector 200 detecting that the injection is complete and the end of stopper movement within the auto-injector) based on the detected temperature, which may be taken into account when determining when the injection is finished. In some embodiments, a given patient's injection data may be tracked through the GUI 222 and transmitted, for example, to an electronic health record (EHR) associated with the patient and accessible to a healthcare professional, allowing the healthcare professional to view the patient's compliance with the medication regimen.

[0127] In some embodiments, detector 200 may further comprise a display (not shown) communicatively coupled to one or more components of detector 200 (e.g., processor 212) and configured to provide at least a portion of the information described above in connection with GUI 222 of mobile computing device 218. For example, detector 200 may comprise a liquid crystal display (LCD) that may display the expected injection time, the detected temperature of the medication, the wait time, etc. In some embodiments, detector 200 may comprise one or more illuminators (e.g., illuminators 208, 220, 221, etc.) in combination with the LCD display.

[0128] 2E illustrates an example printed circuit board (PCB) implementation of detector 200. In some embodiments, user-controlled actuator 204 may comprise a PCB switch. In some embodiments, processor 212 may include a microcontroller. In some embodiments, temperature sensor 206 may include a thermistor. The PCB of detector 200 may include multiple indicators. For example, detector 200 may include a speaker 210 (e.g., a piezoelectric sounder), an illuminator 208 (e.g., an LED) configured to indicate when the medication is ready to be used, and an illuminator 220 (e.g., an LED) configured to indicate when the medication is not ready to be used. In some embodiments, power source 216 of detector 200 may include a battery (e.g., a single-use or rechargeable battery). In some embodiments, the battery may be configured to be removable from a retainer on the PCB so that the battery may be removed after use of detector 200 (e.g., if detector 200 and / or medication are single-use). The PCB of the detector 200 may be housed within a housing configured to be attached to the pharmaceutical product. In some embodiments, the PCB of the detector 200 is embodied within the housing of the pharmaceutical product. An exemplary housing is shown in FIG. 1 for the detector 100 and pharmaceutical product 102.

[0129] Exemplary uses of the electronic detector 200 are provided herein. In some embodiments, a user can remove a medication with the detector 200 attached from a controlled cooling environment (e.g., a refrigerator) and from the medication's packaging and activate the detector 200 via the user-controlled actuator 204, which can cause the temperature sensor 206 to automatically begin detecting the medication's temperature. Upon activation of the device, the illuminator 220 can illuminate to indicate to the user that the detector 200 is activated but is not yet at the appropriate temperature for use and therefore not ready for use. Additionally, upon detecting a first temperature (e.g., a bleach temperature) outside the standard refrigeration range (which can occur substantially simultaneously with the illuminator 220 being activated), a timer can begin passively measuring the elapsed time. After a specified amount of time has elapsed, the processor 212 (which can include a timer that measures the elapsed time) can turn on the illuminator 208 and turn off the illuminator 220. By activating the illuminator 208, the detector 200 can indicate to the user that the medication is within the appropriate temperature range for use. In some embodiments, the temperature range suitable for use may correspond to a standard ambient (e.g., room) temperature range of 20° C. to 22° C. In some embodiments, the temperature range suitable for use may range from 15° C. to 30° C., depending at least on the API of the pharmaceutical agent. In some embodiments, the user may be further notified that the pharmaceutical agent is ready for use from an audible indication generated by the speaker 210 and / or via a notification on the GUI 222 of the mobile computing device 218.

[0130] Exemplary Relationship Between API and Vessel Temperature FIG. 3 shows an exemplary plot of temperature versus time, where the temperature of the container, the temperature of the liquid (e.g., API) contained within the container, and the ambient room temperature (e.g., 21.7°C in this example) are measured over time. The plot in FIG. 3 may demonstrate a relationship between the temperatures of each of three entities (e.g., the liquid, the container, and the room). In some embodiments, the relationship between at least the temperature of the liquid and the container may be applied within one or more algorithms configured in detector 200, such that when detector 200 detects the temperature of the container, the temperature of the API within the container may be estimated (e.g., extrapolated) based on the plotted and / or tabulated relationship, as described above. As shown, the temperatures of the container and the liquid may increase at substantially the same rate over time, although the temperature of the liquid may initially be lower due to its storage in a controlled, cooled environment. Thus, depending on one or more factors, such as the type of liquid, the material of the container, the volume of the liquid, and the presence or absence of voids, the container may reach room temperature faster than the liquid. For example, based on the heat capacity of the container (e.g., depending at least on the mass and specific heat of the container), the rate at which heat is transferred from the ambient environment through the container to the API may vary. As shown, the temperature difference between the temperature of the container and the temperature of the liquid may decrease over time. Thus, in some embodiments, the temperature of the container may not need to reach ambient room temperature for the pharmaceutical product to be ready for use. This relationship may be determined and tabulated for multiple container materials, liquid types, and liquid volumes, for use, for example, in an algorithm that determines when the pharmaceutical product is ready for use.

[0131] Fluid-based detectors for pharmaceuticals 1 may be embodied in a fluid-based system including one or more fluids (e.g., liquid, gas) that are selected to detect a change in the temperature of a pharmaceutical product and that can move for a specified duration before indicating whether the pharmaceutical product is ready to be used. Figures 4A-4E show various fluid-based detectors configured to detect the temperature of a pharmaceutical product and indicate whether the pharmaceutical product is ready to be used when a specified length of time has elapsed, according to some embodiments.

[0132] FIG. 4A shows the front end of a fluid-based detector 400 at different stages of use, where the detector 400 is configured to detect the temperature of a pharmaceutical product and indicate whether the pharmaceutical product is ready for use after a specified amount of time has elapsed. The detector 400 may include any one or more features of the detectors 100, 200 described above with respect to FIGS. 1 and 2A-2F. For example, the detector 400 may be removably attached to the pharmaceutical product (e.g., using an adhesive). In some embodiments, the detector 400 may be disposable and single-use due to one or more irreversible features. The detector 400 may include a user-controlled actuator 404, a temperature sensor 406, and an indicator 408. In some embodiments, the user-controlled actuator 404 may include a button (e.g., a blister) configured to activate the movement of a fluid contained within a reservoir (e.g., a sealed pod) associated with the button. The fluid may include a miscible fluid (e.g., a dyed liquid, a gel, etc.). In some embodiments, the temperature of the fluid at detector 400 may be related (e.g., via one or more empirical relationships) to the temperature of the active pharmaceutical ingredient (API) contained within the pharmaceutical product, such that the detected temperature of the fluid may be used to determine when the pharmaceutical product is ready for use.

[0133] In some embodiments, the temperature sensor 406 and the indicator 408 may each comprise a window and a reservoir (e.g., a chamber) so that a user can view the fluid (e.g., liquid) in the reservoir through the window to indicate the status of the detector 400. The windows of the indicator 408 and the temperature sensor 406 may comprise a circular, oval, rectangular, or other shape. In some embodiments, the windows of the indicator 408 and the temperature sensor 406 may comprise substantially the same shape. In some embodiments, the window of the temperature sensor 406 may be one shape (e.g., rectangular) and the window of the indicator 408 may be a different shape (e.g., oval).

[0134] As shown, prior to use, the temperature sensor window and indicator window may be empty (e.g., empty) reservoirs. When the detector 400 is activated, fluid may move from a reservoir associated with the user-controlled actuator 404 to the temperature sensor 406, indicating that the detector is activated. For example, the user-controlled actuator 404 may be configured to induce pressure in a fluid-containing reservoir of the detector 400, such that when the user-controlled actuator 404 is pressed or depressed (e.g., for 1, 2, 3, or more seconds), fluid contained within the reservoir may be forced from the reservoir toward the temperature sensor 406 (e.g., via one or more capillaries, as described in more detail with respect to FIGS. 4B-4E ). In some embodiments, the fluid contained within the reservoir associated with the user-controlled actuator 404 may be configured to begin moving toward the temperature sensor 406 upon detection of a temperature change that may affect the state of the fluid (e.g., at the fluid's melting point, where the fluid changes from a solid to a liquid). After a specified amount of time, the fluid visible in the temperature sensor 406 may migrate (e.g., via one or more capillaries, a substrate, a gel, etc.) and become visible in the indicator 408, indicating that the medication is ready for use.

[0135] In some embodiments, the temperature sensor 406 may include a label configured to indicate that the detector 400 is operational but the medication is not ready for use (e.g., "On," "Operating," "Not ready for use," "Not ready," etc.). Similarly, the indicator 408 may include a label configured to indicate that the medication is ready for use (e.g., "Ready," "Ready to be used," "Ready for use," etc.). Each of the labels may be disposed on and / or adjacent to a window of the sensor and indicator. For example, the label may be disposed on the window such that when a reservoir associated with the window of the sensor and indicator is empty, the label is unreadable and when the reservoir contains fluid, the label is readable. The manner in which fluid may move from a reservoir associated with the user-controlled actuator 404 to each of the reservoirs of the temperature sensor 406 and the indicator 408, according to some embodiments, is described in more detail below with respect to FIGS. 4B-4E .

[0136] 4B shows the back end of the detector 400, which includes a fluid reservoir 428 and one or more substrate pathways 430, 432. As described above, fluid can be configured to move from the fluid reservoir 428 associated with the user-controlled actuator 404 upon actuation of the detector 400. In some embodiments, the fluid reservoir 428 can be fluidly connected to a reservoir of the temperature sensor 406 via one or more capillaries (e.g., fluid pathways). In some embodiments, the interface between the reservoir 428 and the capillaries configured to connect the reservoir 428 to the reservoir of the temperature sensor 406 can include one or more valves (not shown). For example, by engaging the user-controlled actuator 404, and thus inducing pressure in the reservoir 428, the valves at the interface can be actuated to allow fluid contained within the reservoir 428 to move through the one or more capillaries toward the reservoir of the temperature sensor 406. In some embodiments, a valve at the interface may be actuated upon detection of a temperature change (e.g., reaching or exceeding the bleach temperature) by the temperature sensor 406. In some embodiments, the time required to travel from the reservoir 428 to the temperature sensor 406 may be negligible and independent of the temperature of the fluid.

[0137] In some embodiments, the fluid may be contained in the reservoir of the temperature sensor 406 until one or more breach temperatures of the fluid are detected. In some embodiments, the fluid in the detector 400 may be selected such that when a first breach temperature of the fluid (e.g., 10°C, 12°C, 14°C, etc.) is detected, at least a portion of the fluid may begin to move through the first substrate pathway 430 (e.g., membrane, gel, etc.). For example, when the first breach temperature is detected, a valve between the reservoir of the temperature sensor 406 and the substrate pathway 430 may be actuated to allow the fluid to move into the substrate pathway 430. In some embodiments, when a second breach temperature of the fluid (e.g., 16°C, 18°C, 20°C, etc.) is detected, at least a portion of the fluid may begin to move through the second substrate pathway 432. For example, when the second breach temperature is detected, a valve between the reservoir of the temperature sensor 406 and the substrate pathway 432 may be actuated to allow the fluid to move into the substrate pathway 432. In some embodiments, the first substrate pathway 430 and the second substrate pathway 432 may each be configured such that fluid may travel through the pathway for a specified length of time. For example, fluid may travel through the first substrate pathway 430 for a first specified length of time (e.g., 50 minutes) and through the second substrate pathway 432 for a second specified length of time (e.g., 10 minutes). Thus, if a second (e.g., higher) bleach temperature is detected, fluid may begin traveling through the second substrate pathway 432, which may require a shorter time to reach the indicator 408.

[0138] In some embodiments, detector 400 may include multiple substrate pathways configured to accommodate various durations for which the pharmaceutical agent is ready for use. For example, in addition to or instead of one or more of the substrate pathways described above, detector 400 may include a third substrate pathway, through which fluid may travel to indicator 408 for a specified length of time regardless of the detected temperature.

[0139] The substrate pathway may comprise a porous membrane, gel, or other material configured to move fluid through the pathway for a specified length of time. In some embodiments, the size (e.g., length, width, etc.) of the substrate pathway within detector 400 may be configured to move fluid for a specified length of time. The specified length of time may correspond to one or more requirements for use of the pharmaceutical product. For example, a given API contained within the pharmaceutical product may be required to sit at ambient temperature (e.g., room temperature) for a particular length of time and / or may be required to reach an appropriate use temperature (e.g., a desired temperature) before use. Thus, one or more substrate pathways 430, 432 may be configured to correspond to a required time, or in some embodiments, may be configured such that the API is at the desired temperature for use when the fluid reaches indicator 408.

[0140] In some embodiments, fluid may be contained within the reservoir of the temperature sensor 406 for a negligible amount of time before moving into one or more substrate pathways 430, 432. For example, when the fluid reservoir of the temperature sensor 406 reaches a threshold pressure, one or more valves at the interface between the temperature sensor 406 and one or more substrate pathways 430, 432 may be actuated to allow fluid to move into the pathways. In some embodiments, as described above, fluid may move through one or more substrate pathways 430, 432 for a specified amount of time. In some embodiments, the specified amount of time may be independent of the temperature of the fluid.

[0141] In some embodiments, fluid may be contained within a reservoir of temperature sensor 406 until a bleach temperature is reached or exceeded. Once the bleach temperature is reached, the fluid in detector 400 may migrate into indicator 408 (e.g., via one or more capillaries, etc.). For example, the bleach temperature may indicate that the pharmaceutical product is ready for use, and thus, fluid may migrate from temperature sensor 406 to indicator 408 for a negligible amount of time (e.g., the fluid path fluidly connecting the indicator may not function as a timing mechanism).

[0142] In some embodiments, one or more of the substrate pathways 430, 432 may be fluidly connected to the indicator 408. As described above, the indicator 408 may be configured to indicate whether the pharmaceutical agent is ready to be used. Thus, as fluid in the detector 400 travels through one or more of the substrate pathways 430, 432, the fluid may travel into a reservoir of the indicator 408. In some embodiments, the indicator 408 may indicate when the pharmaceutical agent is ready to be used when fluid traveling from the first substrate pathway 430 or the second substrate pathway 432 reaches the reservoir of the indicator 408 (e.g., whichever occurs first).

[0143] 4C illustrates a fluid-based detector 400 that includes two or more fluids. In some embodiments, the fluid in reservoir 434 may be different from the fluid in reservoir 428, such that the two individual fluids are configured to move to temperature sensor 406 upon reaching or exceeding different breach temperatures, for example. For example, upon actuation by user-controlled actuator 404 (described in more detail above), a first fluid (e.g., the fluid in reservoir 428) may be configured to move to temperature sensor 406 upon reaching a first breach temperature (e.g., 10°C, 12°C, 14°C, etc.). Similarly, upon actuation via user-controlled actuator 404, a second fluid (e.g., the fluid in reservoir 434) may be configured to move to temperature sensor 406 upon reaching a second breach temperature (e.g., 16°C, 18°C, 20°C, etc.) (e.g., whichever occurs first). In some embodiments, the fluid in reservoir 428 may move at a first rate and the fluid in reservoir 434 may move at a second rate, the rates depending on the detected temperature. Fluid from reservoirs 428, 434 may move from temperature sensor 406 to indicator 408 to indicate when the medication is ready for use in a manner similar to that described above with respect to FIG. 4B.

[0144] In some embodiments, the substrate pathways of the detector 400 may be embodied in various configurations. The configuration of each substrate pathway may be selected to correspond to a specified length of time, such that the time required to travel through a given substrate pathway corresponds to the time required for the pharmaceutical to be ready for use. FIG. 4D shows the detector 400 with one or more gel-filled fluid pathways 436, 438 configured to transport the detector's fluid from the temperature sensor 406 to the indicator 408 to indicate whether the pharmaceutical is ready for use. In some embodiments, one or more characteristics of the fluid pathways 436, 438 may be altered to correspond to the time required for the pharmaceutical to reach a desired temperature. In some embodiments, the characteristics of the fluid pathways 436, 438 may be altered to correspond to the length of time the pharmaceutical must remain outside of a controlled cooling environment before use. For example, the length, width, configuration, and gel type of the pathways 436, 438 may be manipulated to correspond to one or more specified lengths of time. In some embodiments, the interface between the temperature sensor 406 and the one or more pathways 436, 438 may include one or more valves that may be activated upon reaching or exceeding one or more bleach temperatures to allow fluid to travel to the indicator 408. In some embodiments, rather than requiring a bleach temperature to be reached or exceeded, fluid may be configured to travel from the temperature sensor 406 into the one or more gel-filled pathways 436, 438 upon reaching a threshold amount of pressure due to fluid traveling from the fluid reservoir 428 to the temperature sensor 406 after activation (e.g., via the user-controlled actuator 404). In some embodiments, the detector 400 may include one or more exhaust pathways 440. The exhaust pathways may be configured to aid fluid circulation within the detector 400 by providing a path into which remaining gel that does not interact with the fluid in the detector 400 can enter as fluid travels through one or more gel-filled fluid pathways toward the indicator 408. As shown in FIG. 4D, the exhaust path can fluidly connect a reservoir of the indicator 408 to, for example, a reservoir 428 associated with the user-controlled actuator 404.

[0145] In some embodiments, the detector 400 may comprise two or more fluids configured to interact and indicate whether the pharmaceutical agent is ready for use. For example, FIG. 4E shows the detector 400 including a gas and a fluid (e.g., a liquid, a gel, etc.). In some embodiments, the gas may be contained within a reservoir 428 associated with the user-controlled actuator 404, such that upon activation, the gas may move from the reservoir 428 through one or more capillaries toward the temperature sensor 406 (e.g., due to induced pressure within the reservoir 404). In some embodiments, one or more capillaries fluidly connecting the reservoir 428 and the reservoir of the temperature sensor 406 may contain a fluid (e.g., a liquid, a gel, etc.), and upon activation of the detector 400, the gas may move the fluid from the capillary into the temperature sensor 406, indicating that the detector 400 is in operation. In some embodiments, the temperature sensor 406 may be fluidly connected to the indicator 408 via one or more substrate pathways 430 (e.g., capillaries). The fluid in detector 400 may travel from temperature sensor 406 to indicator 408 for a specified length of time configured to correspond, for example, to the length of time required for a pharmaceutical product to rest before use. In some embodiments, the specified length of time may be configured to correspond to the time required for the pharmaceutical product to reach an appropriate use temperature.

[0146] In some embodiments, detector 400 may include one or more valves, for example, at the interface between reservoir 428 and a capillary tube fluidly connecting the reservoir to temperature sensor 406. Thus, when a user activates detector 400, gas contained in a reservoir associated with user-controlled actuator 404 may be configured to activate a valve, allowing the gas to migrate into the capillary tube. In some embodiments, the interface between the capillary tube and temperature sensor 406 may alternatively or additionally include a valve configured to be activated when gas enters the capillary tube, increasing the pressure within the capillary tube, thus allowing fluid within the capillary tube to enter the reservoir of temperature sensor 406 through the valve. In some embodiments, the one or more valves may be activated in response to detecting one or more breach temperatures of the fluid. In some embodiments, the fluid may begin to migrate from temperature sensor 406 toward indicator 408 upon reaching or exceeding the breach temperature. In some embodiments, detector 400 may include one or more vents configured to allow any trapped gas in detector 400 to exit. For example, the vent 440 may be fluidly connected to a reservoir of the indicator 408 such that when a fluid (e.g., a liquid, a gel, etc.) moves through one or more reservoirs of the detector 400 toward the reservoir of the indicator 408, gas may be released from the vent 440.

[0147] Liquid crystal sensors for pharmaceuticals 1 may be embodied in a liquid crystal (e.g., thermochromic) sensor that includes liquid crystals that can detect temperature changes in a pharmaceutical product and change color to indicate whether the pharmaceutical product is ready for use. Figures 5A-5H show various liquid crystal sensors configured to detect the temperature of a pharmaceutical product and indicate whether the pharmaceutical product is ready for use, according to some embodiments.

[0148] 5A-5H illustrate a liquid crystal sensor 500 configured to detect a change in temperature of a pharmaceutical product and indicate when the pharmaceutical product is ready for use. For example, a liquid crystal disposed on a polymer may be configured to change color at a specified temperature and / or time to indicate whether the pharmaceutical product is ready for use. In some embodiments, the liquid crystal sensor 500 may include any one or more features of the detectors 100, 200, and / or 400 described above with respect to FIGS. 1, 2A-2F, and / or 4A-4E.

[0149] As shown in FIG. 5A , the liquid crystal sensor 500 can include a first indicator 520 configured to indicate whether the medication is not ready for use and a second indicator 508 configured to indicate whether the medication is ready for use. In some embodiments, one or more of the first indicator and the second indicator can include a liquid crystal configured to detect the temperature of the medication and change color as the temperature of the medication increases (e.g., warms). In some embodiments, the liquid crystal of the liquid crystal sensor 500 can be configured to resemble a meter when it changes color, as shown in FIG. 5A . The indicator 508 can be configured to correspond to a portion of the meter that can indicate whether the medication is ready for use. For example, the indicator 508 can include colored markings that can separate a first portion of the meter (e.g., when the medication is not ready for use) from a second portion of the meter (e.g., when the medication is ready for use). In some embodiments, the indicator 508 can additionally or alternatively include an icon (e.g., a check mark, a thumbs-up, a text label, etc.) disposed adjacent to and / or within the second portion of the meter to indicate whether the medication is ready for use.

[0150] In some embodiments, the liquid crystal may be configured to initially change color at the end of the meter in the first indicator 520 when the medication to which the liquid crystal sensor 500 is attached is removed from a controlled cooling environment (e.g., a refrigerator, freezer, etc.). As the medication continues to warm to an appropriate use temperature (e.g., ambient temperature), additional liquid crystals in the sensor 500 may change color to "fill" the meter. For example, the liquid crystals between the end of the meter in the indicator 520 and the second indicator region 508 may change color over time as the detected temperature increases. After a designated time has elapsed and / or when ambient temperature is detected, the liquid crystal associated with the second indicator 508 may be configured to change color to indicate that the medication is ready for use.

[0151] FIG. 5B illustrates a liquid crystal sensor 500 including a first indicator 520 configured to indicate whether the medication is ready for use and a second indicator 508 configured to indicate whether the medication is ready for use. Similar to the sensor 500 described above with respect to FIG. 5A, one or more of the indicators may include liquid crystals. For example, the liquid crystals in the indicator 520 may be configured to “fill” a meter visualization as the detected temperature of the medication warms. The liquid crystals may be configured to change color in a sequential pattern such that the meter fills over time in a direction toward the second indicator 508. In some embodiments, the second indicator 508 may include a colored box configured to indicate a portion of the meter that may correspond to when the medication is ready for use. For example, the medication may be ready for use when the liquid crystals disposed within the box of the indicator 508 change color. In some embodiments, the box of the indicator 508 may be permanently visible (e.g., it may not include liquid crystals configured to change color based on the detected temperature). In some embodiments, indicator 508 may be highlighted with a color different from the color of the liquid crystal (e.g., the liquid crystal showing the meter may be red and indicator 508 may be green). In some embodiments, indicator 508 may include a label configured to inform the user that the medication is ready to be used when the liquid crystal disposed within indicator 508 changes color (e.g., "Ready," "Ready to Use," etc.).

[0152] In some embodiments, the liquid crystal sensor may further provide one or more of an expected injection time, a detected temperature of the medication, a time when the medication will be ready for use, etc. For example, the liquid crystal sensor 500 shown in FIG. 5C may indicate, using one or more icons and / or text fields, when the medication is not ready for use, but after a time has elapsed, indicate that the medication is ready for use (508) in addition to one or more injection times 542. For example, a first injection time may correspond to a length of time for injection of the API if the medication is injected at a low temperature (i.e., high viscosity) before reaching a suitable temperature for use. A second displayed injection time may correspond to a length of time for injection of the API if the API is injected at a suitable temperature for use (e.g., the injection time may be estimated and displayed in advance of the time to inject the API).

[0153] Similarly, FIG. 5D illustrates a liquid crystal sensor 500 that includes an indication (e.g., an icon and / or text field) 520 that indicates when the medication is not ready for use, in addition to a meter configured to dynamically update to display the injection rate (542). In some embodiments, the meter may be consistently displayed on the liquid crystal sensor 500, and the indicator on the meter may be configured to move (e.g., the liquid crystal may change color) based on the detected temperature. For example, the indicator may move from the "slow" end of the meter to the "fast" end of the meter as the medication warms, indicating that the injection time (e.g., rate) is increasing. As shown in FIG. 5D, when the medication is ready for use, the liquid crystal (520) that previously indicated the medication's status may be configured to change color, and the liquid crystal sensor 500 may display the expected injection rate of the API.

[0154] 5E illustrates a liquid crystal sensor 500 comprising multiple indicators (e.g., graphics, icons, etc.) configured to indicate whether a medication is ready for use. For example, when the liquid crystal sensor 500 detects a temperature change in the medication, the liquid crystal comprising the indicator may change color (e.g., fade) over time until no indicator is present on the detector. When the indicator 520 disappears, the medication may be ready for use.

[0155] 5F illustrates a liquid crystal sensor 500 including an indicator 520 configured to indicate that the medication is not ready for use. For example, the indicator 520 may include an empty icon (e.g., an outline of a shape such as a circle, square, oval, star, triangle, etc.). When the liquid crystal detects a change in temperature, the empty icon may be configured to change color and / or fill, as indicated by the indicator 508. For example, the indicator may change from a first color (e.g., red) to a second color (e.g., green). The indicator 508 configured to indicate that the medication is ready for use may further include one or more ubiquitous icons (e.g., a thumbs-up, a star, a check mark, etc.) that may appear when the medication is ready for use.

[0156] FIG. 5G illustrates a liquid crystal sensor including one or more features of FIGS. 5A-5B above. For example, the liquid crystal sensor 500 illustrated in FIG. 5G may comprise a meter having a first portion / end (520) configured to indicate when a medication is not ready for use and a second portion / end (508) configured to indicate when the medication is ready for use. In some embodiments, the liquid crystal comprising the meter may dynamically change color over time from the first end to the second end as the detected temperature increases to indicate when the medication is ready for use and / or is ready for use.

[0157] 5H illustrates a liquid crystal sensor configured to indicate when a medication is ready for use and relay information about the medication's temperature as it warms. For example, liquid crystal sensor 500 may include a scale with a temperature benchmark at a first end (520) of the scale that may indicate when a low temperature is detected. After a period of time, a temperature benchmark on a second end of the scale (e.g., corresponding to when the medication is ready for use) may be gradually displayed. In some embodiments, the appropriate temperature for use may be highlighted (e.g., outlined on indicator 520) to indicate when the medication is ready for use.

[0158] Each of the liquid crystal sensors 500 described above with respect to Figures 5A-5H can include one or more features described with respect to other embodiments. For example, the detector 500 described with respect to Figure 5A can include one or more features of the detector 500 described with respect to Figure 5H (e.g., the detector 500 of Figure 5A can further display temperature information). The various embodiments and illustrations of the liquid crystal sensor 500 are not intended to be construed as individual embodiments, but rather to demonstrate various features that can be implemented in combination using liquid crystal (e.g., thermochromic) sensing to indicate at least when a pharmaceutical product is ready for use.

[0159] Color-changing materials for pharmaceuticals In some embodiments, one or more components of detector 100 described above with respect to FIG. 1 may be embodied within the pharmaceutical product itself. For example, a pharmaceutical product container may include one or more color-changing materials configured to detect the temperature of the pharmaceutical product and change color when the pharmaceutical product is at a suitable temperature for use. In some embodiments, the color-changing material of the pharmaceutical product may be configured to change color over a specified period of time, such that the pharmaceutical product is ready for use after the specified amount of time has elapsed. In some embodiments, the rate at which the color-changing material of the pharmaceutical product changes color may be selected based on one or more characteristics (e.g., type, volume, etc.) of the API contained within the pharmaceutical product.

[0160] In some embodiments, the container of the medication may include a window (e.g., a window on a syringe holder) configured to change color at an appropriate use temperature. In some embodiments, the window may additionally or alternatively change color after a specified amount of time has elapsed after the medication is removed from the refrigerator. In some embodiments, the window may change from opaque to transparent, or vice versa. In some embodiments, additional or different components of the medication may be configured to change color in response to detection of an appropriate use temperature and / or the passage of a specified amount of time. For example, the cap of an auto-injector may be configured to change from opaque to transparent (or vice versa) when the medication is ready to be used.

[0161] In some embodiments, one or more components of the pharmaceutical agent may include a color-changing polymer. For example, if the container of the pharmaceutical agent is a drug delivery device (e.g., a syringe), the needle guard of the device may be configured to change color when the pharmaceutical agent is ready to be used (e.g., based on one or more of the temperature reached and / or time). In some embodiments, additionally or alternatively, the plunger of the drug delivery device may be configured to change color when the pharmaceutical agent is ready to be used. In some embodiments, one or more internal components of the drug delivery device may change color when the pharmaceutical agent is ready to be used, and the user can view the internal color-changing components through a window (e.g., on a syringe holder).

[0162] In some embodiments, the pharmaceutical product may include any combination of the detection systems described above. For example, the pharmaceutical product may include a liquid crystal sensor configured to indicate the time for injection and one or more color-changing materials configured to indicate when the pharmaceutical product is ready to be used. In some embodiments, the pharmaceutical product may include one or more illuminators (e.g., LED light indicators) and an LED display screen configured to indicate the time for injection. The examples provided are not intended to be limiting, and it should be understood that any combination of the features of the detection systems described herein may be combined to indicate at least when the pharmaceutical product is ready to be used.

[0163] How to indicate when a drug is ready for use As described above, the detectors disclosed herein can be configured to be attached to a pharmaceutical product to detect the temperature of the pharmaceutical product and indicate when the pharmaceutical product is ready for use. The pharmaceutical product can include a container configured to contain an active pharmaceutical ingredient (API). Figure 6 illustrates a method 600 for detecting the temperature of a pharmaceutical product and indicating when the pharmaceutical product is ready for use, according to some embodiments.

[0164] In step 602, a temperature sensor in the detector may detect the temperature of the pharmaceutical product. In step 604, at least one timer in the detector may begin measuring an elapsed time when the detected temperature of the pharmaceutical product reaches or exceeds a bleach temperature. In some embodiments, the timer may be embodied in the detector's processor, as described above. In step 606, at least one indicator in the detector may generate an indication that the pharmaceutical product is ready for use when a specified amount of time on the at least one timer has elapsed. In some embodiments, the specified amount of time may be selected to correspond to when an API contained within the pharmaceutical product is ready for use. In some embodiments, the specified amount of time may be selected to correspond to the time it takes for an API contained within the pharmaceutical product to reach a desired temperature when placed in an environment within a standard room temperature range.

[0165] The above description describes example systems, methods, techniques, parameters, etc. However, it should be recognized that such description is not intended as a limitation on the scope of the present disclosure, but is instead provided as a description of example embodiments.

[0166] Although the description herein uses terms such as first, second, etc. to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another.

Claims

1. 1. A detector configured to be attached to a pharmaceutical product containing an active pharmaceutical ingredient (API), comprising: a temperature sensor configured to detect a temperature of the pharmaceutical product; at least one timer configured to initiate measurement of elapsed time when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a bleach temperature; at least one indicator configured to generate an indication that the medication is ready for use when a specified amount of time has elapsed on the at least one timer; A detector comprising:

2. 10. The detector of claim 1, wherein the specified amount of time is selected to correspond to when the active pharmaceutical ingredient (API) in the pharmaceutical product is ready for use.

3. 3. The detector of claim 1 or 2, wherein the specified amount of time is selected to correspond to an amount of time for the active pharmaceutical ingredient (API) contained within the pharmaceutical product to reach a desired temperature when placed in an environment within a standard room temperature range.

4. 4. A detector according to any one of claims 1 to 3, wherein the bleach temperature corresponds to a temperature outside the standard refrigeration temperature range.

5. A pharmaceutical product, a container configured to contain an active pharmaceutical ingredient (API); A detector according to any one of claims 1 to 4, arranged adjacent to the container; A pharmaceutical product comprising:

6. 6. The pharmaceutical product of claim 5, wherein the container comprises a syringe configured to contain the active pharmaceutical ingredient (API).

7. The pharmaceutical product of claim 6 , wherein the syringe comprises an auto-injector.

8. 8. The pharmaceutical product of claim 5, wherein the temperature sensor determines the temperature of the active pharmaceutical ingredient (API) based at least in part on the temperature of the container.

9. The pharmaceutical product according to any one of claims 5 to 8, wherein the detector is removably attached to the container.

10. A detector according to any preceding claim, comprising a user-controlled actuator configured to activate the temperature sensor.

11. 11. The detector of claim 1, wherein the at least one timer is configured to initiate measuring a second elapsed time when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a second bleach temperature.

12. The detector of claim 11 , wherein the second bleach temperature is greater than the bleach temperature.

13. 13. The detector of claim 11 or 12, wherein a first timer of the at least one timer is configured to measure the elapsed time when the breach temperature is detected, and a second timer of the at least one timer is configured to measure the second elapsed time when the second breach temperature is detected.

14. 14. The detector of claim 11, wherein the elapsed time measured by the at least one timer is of longer duration than the second elapsed time measured by the at least one timer.

15. 15. The detector of any one of claims 11 to 14, wherein the at least one indicator is configured to generate an indication that the medicinal product is ready for use when a second specified amount of time has elapsed on the at least one timer.

16. A detector according to any preceding claim, wherein the at least one indicator comprises at least one of an audio indicator and / or a visual indicator.

17. 17. The detector of claim 16, wherein the visual indicator includes a first illuminator configured to be activated when the medication is ready to be used.

18. 18. The detector of claim 17, wherein the visual indicator includes a second illuminator configured to be activated when the medication is not ready for use.

19. A detector according to any one of claims 16 to 18, wherein the audio indicator is configured to produce a sound when the medicine is ready to be used.

20. 20. The detector of any one of claims 1 to 19, wherein the indicator comprises a graphical user interface (GUI) on a mobile device configured to indicate when the medication is ready for use.

21. The detector of claim 20 , wherein the mobile device is communicatively coupled to one or more of the temperature sensor and the timer.

22. 22. The detector of claim 20 or 21, wherein the graphical user interface (GUI) is configured to display an expected duration of an injection based at least in part on the detected temperature and the medication.

23. A detector according to any preceding claim, comprising a fluid configured to move through the temperature sensor and the at least one timer.

24. 24. The detector of claim 23, comprising a user-controlled actuator configured, when actuated, to move the fluid from a reservoir associated with the user-controlled actuator to the temperature sensor.

25. 25. The detector of claim 24, wherein the temperature sensor comprises a window configured to indicate that the detector is in operation.

26. 26. The detector of claim 24 or 25, wherein the fluid is configured to move from the temperature sensor through the at least one timer when the pharmaceutical product reaches or exceeds the bleach temperature.

27. 27. The detector of claim 26, wherein the fluid is configured to travel through the at least one timer to the at least one indicator for the specified amount of time.

28. 28. The detector of claim 27, wherein the specified amount of time corresponds to when the active pharmaceutical ingredient (API) in the pharmaceutical product is ready for use.

29. 29. The detector of claim 27 or 28, wherein the fluid is configured to move from the temperature sensor through a second timer of the at least one timer when the pharmaceutical agent reaches or exceeds a second bleach temperature.

30. 30. The detector of claim 29, wherein the fluid is configured to travel through the second timer to the at least one indicator for a second specified amount of time.

31. 31. The detector of claim 30, wherein the second bleach temperature is greater than the bleach temperature and the second specified length of time is greater than the specified length of time.

32. 1. A method for indicating that a pharmaceutical product is ready for use, comprising: detecting the temperature of the pharmaceutical product using a temperature sensor; using at least one timer to measure the time elapsed when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a bleach temperature; generating, using at least one indicator, an indication that the medication is ready for use when a specified amount of time has elapsed on the at least one timer; A method comprising:

33. 33. The method of claim 32, wherein the specified amount of time is selected to correspond to when an active pharmaceutical ingredient (API) within the pharmaceutical product is ready for use.

34. 34. The method of claim 32 or 33, wherein the specified amount of time is selected to correspond to the amount of time it takes the active pharmaceutical ingredient (API) contained within the pharmaceutical product to reach a desired temperature when placed in an environment within a standard room temperature range.

35. 35. The method of any one of claims 32 to 34, wherein the bleaching temperature corresponds to a temperature outside the standard refrigeration temperature range.

36. A method according to any one of claims 32 to 35, comprising activating the temperature sensor with a user-controlled actuator.

37. 37. The method of any one of claims 32 to 36, comprising measuring a second elapsed time using the at least one timer when the temperature of the pharmaceutical product detected by the temperature sensor reaches or exceeds a second bleach temperature.

38. 38. The method of claim 37, wherein the second bleaching temperature is higher than the bleaching temperature.

39. 39. The method of claim 37 or 38, wherein a first timer of the at least one timer is configured to measure the elapsed time when the bleach temperature is detected, and a second timer of the at least one timer is configured to measure the second elapsed time when the second bleach temperature is detected.

40. 40. The method of any one of claims 37 to 39, wherein the elapsed time measured by the at least one timer is of longer duration than the second elapsed time measured by the at least one timer.

41. 41. The method of any one of claims 37 to 40, comprising generating, using the at least one indicator, an indication that the medicinal product is ready for use when a second specified amount of time has elapsed on the at least one timer.

42. The method of any one of claims 32 to 41, wherein the at least one indicator comprises at least one of an audio indicator and / or a visual indicator.

43. 43. The method of claim 42, comprising activating the at least one visual indicator when the medication is ready for use.

44. 44. The method of claim 43, comprising activating a second visual indicator of the at least one visual indicator if the medication is not ready for use.

45. 45. A method according to any one of claims 42 to 44, comprising activating the audio indicator to produce a sound when the medicine is ready for use.

46. 46. ​​The method of any one of claims 32 to 45, comprising indicating on a graphical user interface (GUI) on a mobile device that the medicinal product is ready for use.

47. 47. The method of claim 46, wherein the mobile device is communicatively coupled to one or more of the temperature sensor and the timer.

48. 48. The method of claim 46 or 47, comprising displaying on the graphical user interface (GUI) an expected duration of the injection based at least in part on the detected temperature and the medication.

49. The method of any one of claims 32 to 48, including a fluid configured to move through the temperature sensor and the at least one timer.

50. 50. The method of claim 49, comprising using a user-controlled actuator to move the fluid from a reservoir associated with the user-controlled actuator to the temperature sensor.

51. 51. The method of claim 50, wherein the fluid travels from the temperature sensor through the at least one timer when the pharmaceutical product reaches or exceeds the bleach temperature.

52. 52. The method of claim 51, wherein the fluid travels through the at least one timer to the at least one indicator for the specified amount of time.

53. 53. The method of claim 52, wherein the specified amount of time corresponds to when the active pharmaceutical ingredient (API) within the pharmaceutical product is ready for use.

54. 54. The method of claim 52 or 53, wherein when the pharmaceutical product reaches or exceeds a second bleach temperature, the fluid travels from the temperature sensor through a second timer of the at least one timer.

55. 55. The method of claim 54, wherein the fluid travels through the second timer to the at least one indicator for a second specified time.

56. 56. The method of claim 55, wherein the second bleaching temperature is greater than the bleaching temperature and the second specified length of time is greater than the specified length of time.

57. 1. A detector configured to be attached to a pharmaceutical product containing an active pharmaceutical ingredient (API), comprising: a temperature sensor configured to detect a temperature of the pharmaceutical product; at least one processor configured to calculate changes between the detected temperatures over time; at least one indicator configured to generate an indication that the medication is ready for use when a change in the calculated change between the detected temperatures over time meets or falls below a predetermined threshold; A detector comprising:

58. 58. The detector of claim 57, wherein the predetermined threshold is selected to correspond to when the active pharmaceutical ingredient (API) in the pharmaceutical product is ready for use.

59. 59. A detector as described in claim 57 or 58, wherein calculating the change between the detected temperatures over time comprises determining a difference between a first temperature and a second temperature, the first temperature and the second temperature being detected a predetermined amount of time apart.

60. 60. The detector of claim 59, wherein the at least one processor is configured to generate a ratio of a difference between the first temperature and the second temperature separated by the predetermined amount of time and compare the ratio to the predetermined threshold.

61. 1. A method for indicating that a pharmaceutical product is ready for use, comprising: detecting the temperature of the pharmaceutical product using a temperature sensor; calculating, with at least one processor, changes between the detected temperatures over time; generating, using at least one indicator, an indication that the medication is ready for use when a change in the calculated change between the detected temperatures over time meets or falls below a predetermined threshold; A method comprising:

62. 62. The method of claim 61, wherein the predetermined threshold is selected to correspond to when an active pharmaceutical ingredient (API) in the pharmaceutical product is ready for use.

63. 63. The method of claim 61 or 62, wherein calculating the change between the detected temperatures over time includes determining a difference between a first temperature and a second temperature, the first temperature and the second temperature being detected a predetermined amount of time apart.

64. 64. The method of any one of claims 61 to 63, wherein the at least one processor generates a ratio of the difference between the first temperature and the second temperature separated by the predetermined amount of time and compares the ratio to the predetermined threshold.

65. 1. A liquid crystal sensor configured to be attached to a pharmaceutical product containing an active pharmaceutical ingredient (API), comprising: a liquid crystal configured to change color to indicate an increase in temperature of the medication as the medication warms; and at least one indicator configured to indicate when the API in the pharmaceutical product has reached a specified temperature or temperature range, the specified temperature or temperature range indicating when the pharmaceutical product is ready for use.

66. 66. The liquid crystal sensor of claim 65, wherein a portion of the liquid crystal is adjacent to the at least one indicator on the liquid crystal sensor and is configured to change color when the medication is ready to be used.

67. 67. A liquid crystal sensor according to claim 65 or 66, wherein the liquid crystal sensor comprises a visual meter that indicates an increase in the temperature of the medication as the medication warms.

68. 68. The liquid crystal sensor of claim 67, wherein the at least one indicator corresponds to an edge of the visual meter.

69. 69. The liquid crystal sensor of any one of claims 65 to 68, wherein the at least one indicator is configured to indicate an expected duration of an injection.

Images