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JP-7855546-B2 - Methods, apparatus, and systems for the delivery of active drugs to the lungs

JP7855546B2JP 7855546 B2JP7855546 B2JP 7855546B2JP-7855546-B2

Inventors

  • デヴィッドソン ペリー
  • アルモグ シュロモ
  • キンドラー セス

Assignees

  • サイケ メディカル リミテッド

Dates

Publication Date
20260508
Application Date
20230405
Priority Date
20140630

Claims (14)

  1. A system for delivering at least one active substance to the lungs, wherein the system is An inhalation device for delivering multiple doses of the at least one active substance to individual users at predetermined time intervals, A mobile phone is provided, and the mobile phone is Means for receiving information on the actual dose administered from the inhalation device, Means for collecting data from individual users regarding at least one effect induced by the at least one active substance, by obtaining feedback data through interaction with the user, including indications of the level of therapeutic effect and/or the level of adverse effect perceived by the user, A storage means for storing the aforementioned feedback data, Means for transferring the collected feedback data to at least one of the following: an external device, the inhalation device, a physician, and the user. Means for generating proposed regimens for multiple doses of the at least one active substance based on the collected feedback data and the information on the actual doses administered, Configured to provide, The generated information of the proposed regimens for the plurality of doses is used by the inhalation device for the subsequent delivery of the at least one active substance in the system.
  2. The system according to claim 1, wherein the feedback data includes an indication of the level of therapeutic effect and an indication of the level of adverse effect as perceived by the user.
  3. The system according to claim 2, wherein the adverse effects include psychoactive effects, and the mobile phone is configured to automatically estimate the user's psychoactive state.
  4. The system according to any one of claims 1 to 3, wherein the mobile phone is configured to obtain the feedback data after the user inhales from the inhalation device.
  5. The system according to any one of claims 1 to 4, wherein one or more components of the mobile phone are configured to function as sensors for obtaining the feedback data.
  6. The system according to any one of claims 1 to 5, wherein the interaction with the user includes one or more games and/or tasks.
  7. The system according to claim 6, wherein the task includes manually and/or visually tracking a target.
  8. The system according to any one of claims 1 to 7, wherein the mobile phone is configured to receive instructions and/or requests from the user relating to one or more of the following: delivery timing, acceptable adverse effects, and desired therapeutic effects.
  9. The system according to any one of claims 1 to 8, wherein the mobile phone is configured to generate the proposed regimen of the at least one active substance.
  10. The inhalation device comprises a cartridge containing a plant-based material from which at least one active substance is vaporized and delivered to the user, according to any one of claims 1 to 9.
  11. Receiving information on the actual dose administered from an inhalation device for lung delivery of at least one active substance, Receiving user feedback data regarding the amount of therapeutic effect and/or adverse effect experienced by the user of the inhalation device, The aforementioned feedback data is stored, The collected feedback data is to be transferred to at least one of the following: an external device, the inhalation device, a physician, and the user. A mobile phone configured to generate proposed regimens for multiple doses of at least one active substance based on the collected feedback data and information on the actual doses administered.
  12. The mobile phone according to claim 11, wherein the adverse effect includes a psychoactive effect, and the mobile phone is configured to automatically estimate the user's psychoactive state.
  13. The mobile phone according to claim 11 or 12, configured to obtain the feedback data after the user inhales from the inhalation device.
  14. The mobile phone according to any one of claims 11 to 13, wherein one or more components of the mobile phone are configured to function as sensors for obtaining the feedback data.

Description

This invention relates to pharmacology in some embodiments, and more particularly to methods, apparatus, and systems for controlled pulmonary delivery of active drugs, but is not limited thereto. Natural substances, such as plant-based materials, offer numerous pharmaceutically active agents capable of providing a wide range of therapeutic and other beneficial effects; however, the use of many such substances for direct pharmacological purposes has been limited by technical and cultural reasons. This is primarily because quantifying the active agents they contain is difficult, making controlled administration challenging, and thus physicians and pharmacologists who recognize the beneficial effects of these substances are reluctant to prescribe them. One of the most widely used and studied natural substances is cannabis, which has beneficial effects in treating nausea and vomiting, multiple sclerosis and other neurological conditions, loss of appetite and weight in cancer and AIDS, neurological pain, insomnia, anxiety and depression, epilepsy and other seizures, asthma, opioid withdrawal, and inhibition of primary tumor growth. It has also been shown to be effective for antipyretic and anti-inflammatory purposes, anthelmintic purposes, anti-migraine, and labor-inducing purposes. Nevertheless, cannabis as a "mainstream" medicine has been a subject of controversy for many years due to the difficulties in administering it according to the typical medical model of drug prescription. The inability to administer cannabis accurately and precisely is a major obstacle to its inclusion in drug regimens, particularly those used for pain management. Furthermore, the lack of a method for administering cannabis in pharmaceutical form makes physician prescription and treatment monitoring difficult, and blurs the lines between medical and recreational use. Consequently, many national regulatory bodies refrain from approving cannabis for medical use. In fact, to date, cannabis is not recognized by the public as a safe substance and is treated primarily as illegal in most countries worldwide. For natural substances such as cannabis to be used as "mainstream" medicines, it is necessary to make these natural substances available in a way that allows the use of their active ingredients to comply with customary medicinal standards and practices regarding administration and regimens. Problems associated with the use of cannabis as a natural substance can be illustrated by a recent study on patterns of medicinal use and prevalence of cannabis, involving 953 participants from 31 countries. This study showed that pulmonary delivery of cannabis was the most preferred route of administration, used by 86.6% of participants (62.9% for smoking and 23.7% for vaporization). Oral delivery of cannabis for edible purposes was used by 10.3% of participants, while only 2.3% used cannabis extract delivered via the oral mucosal route (Sativex®) in tablet form or by synthetic cannabinoids (Marinol® and Nabilone®). This is partly due to the slow and irregular absorption of cannabinoids via oral administration, leading to delayed onset and often insufficient analgesia. Randomized, controlled, double-blind, double-dummy trials of oral mucosal delivery of cannabis revealed similar pharmacokinetic patterns to those of oral use. Smoking cannabis products provides a basis for a rapid and efficient method of cannabinoid delivery. During smoking cannabis products, THC plasma levels rise rapidly, typically reaching peak concentrations within 1-3 minutes, resulting in the first onset of effects approximately 7 minutes later. However, variations in inhalation intensity, smoking duration, and respiratory retention time, coupled with the estimated destruction of about 30% of the THC dose by pyrolysis during smoking, lead to a heterogeneous bioavailability of 2-56% via the smoking pathway. This diverse bioavailability, coupled with smoking-related pyrolysis byproducts that can cause various diseases, makes smoking an undesirable method of cannabinoid delivery. A step forward is being taken in developing cannabis vaporization technology aimed at delivering inhaled cannabinoids while avoiding the respiratory hazards of smoking. While the core temperature of a burning cigarette reaches 750–800°C, cannabis vaporization can be performed at 170–190°C. Within this temperature range, active cannabinoids, as well as flavonoids and terpenoid vapors, are formed below the combustion point (230–235°C), where pyrolytically decomposable toxic compounds are generated. Vaporization technology has been shown to reduce the formation of carbon monoxide and highly carcinogenic compounds such as polynuclear aromatic hydrocarbons (PAHs), benzene, and tar. Recent clinical trials enrolling patient populations with chronic neuropathic pain of various etiologies have indicated that low doses of Δ9- THC have a favorable risk-benefit ratio. Ware et al. [Non-Patent Literature 1] reported that