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(12) Patent Application Publication (10) Pub. No.: US 2015/0297653 A1 Speier (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2015/0297653 A1 Speier (43) Pub US 20150297653A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0297653 A1 Speier (43) Pub. Date: Oct. 22, 2015 (54) PHARMACEUTICAL COMPOSITION AND Publication Classification METHOD OF MANUFACTURING (51) Int. Cl. (71) Applicant: Gary J. Speier, Eden Prairie, MN (US) A61E36/85 (2006.01) (52) U.S. Cl. (72) Inventor: Gary J. Speier, Eden Prairie, MN (US) CPC ........... A61K 36/185 (2013.01); A61 K 2236/37 (2013.01) (21) Appl. No.: 14/694,303 (57) ABSTRACT The present invention provides for methods of obtaining an extract of Cannabis plant material as well as Subsequent (22) Filed: Apr. 23, 2015 processing of the extract to provide a concentrate of Can nabis. The present invention also provides for pharmaceutical O O dosage forms (e.g., oral thin films and transdermal patches) Related U.S. Application Data that include the concentrate (or extract) of Cannabis, as well (63) Continuation of application No. 14/255.296, filed on as methods of medical treatment that include administering Apr. 17, 2014, now Pat. No. 9,044.390. the pharmaceutical dosage forms. US 2015/0297653 A1 Oct. 22, 2015 PHARMACEUTICAL COMPOSITION AND ing Cannabis. Unfortunately, there are concerns about the METHOD OF MANUFACTURING effect of this mode of administration on the lungs. Cannabis Smoke carries even more tars and other particulate matter than CLAIM OF PRIORITY tobacco, and so may be a cause of lung cancer. Furthermore, many patients find the act of Smoking unappealing, as well as 0001. This patent application is a Continuation of U.S. generally unhealthy. It is known that some of the chemicals patent application Ser. No. 14/255.296, filed Apr. 17, 2014, produced by Smoking Cannabis are aggressive and Smoking and is incorporated by reference herein. has been shown to cause the gradual dissolving of teeth. Use of vaporizers for inhalation administration of Cannabis does BACKGROUND not avoid the production of thermal byproducts, and also can 0002 The medicinal and psychoactive properties of the produce tracheal and lung irritation. For these reasons, Smok Cannabis plant have been known for centuries. At present, ing is not an approved medical means of administration for Cannabis is not legally available in many States. However, any drug. there is growing pressure on politicians to legalize its use, 0011 Attempts have been made to overcome some of the especially for medicinal purposes. problems associated with Smoking both Cannabis and 0003) Evidence suggests that Cannabis is a safe, versatile tobacco by providing various Smokeless inhalable aerosol and potentially inexpensive drug. It has been reported as formulations for lung delivery. A self-propelled inhalable being beneficial to patients Suffering from a wide range of aerosol of delta-9-tetrahydrocannabinol was developed as symptoms experienced in connection with various, often very long ago as 1975 as a bronchodilator. Inhalable aerosol for serious, medical conditions. For example, Cannabis has been mulations were made comprising either only liquid compo used to alleviate symptoms associated with cancer, anorexia, nents and or including a solid particulate component carrying AIDS, chronic pain, spacicity, glaucoma, arthritis, migraine the active agent, such as the Cannabis. The various formula and many other illnesses. tions were found to be of varying effectiveness in delivering 0004 Cannabis is recognized as having anti-emetic prop the active agent to the alveoli of the lungs in the same manner erties and has been Successfully used to treat nausea and as Smoke. Vomiting in cancer patients undergoing chemotherapy. 0012 However, both methods of lung delivery discussed 0005 Studies also report use of Cannabis in treating the above have been found to cause apronounced and involuntary weight loss syndrome of AIDS and in reducing intraocular cough, possibly from irritation of the trachea and lungs. This pressure for the treatment of glaucoma. Cannabis is also unpleasant side effect is not overcome by the smoke-free reported to have muscle relaxing effects and anti-convulsant method of lung delivery. effects. 0013 An oral dosage form of Cannabis is available in the 0006. However, it is also well documented that these United States as a Schedule II drug. The capsules contain a medicinal effects of Cannabis come at the cost of less desir synthetic version of delta-9-tetrahydrocannabinol (delta-9- able effects. It is alleged that the administration of Cannabis THC), the main active substance in Cannabis, and they have causes changes in mood, perception and motivation. The had limited success for a number of reasons. Firstly, in light of common euphoric effects have led to the use of Cannabis as its anti-emetic properties, the capsules are commonly used to a recreational, “soft drug and its criminalization. The psy treat nausea and Vomiting. Clearly, an oral administration is choactive effects are said to vary with dose, with the typical not ideal as the patient may well have difficulty keeping the Cannabis Smoker experiencing a “high which lasts about 2 capsule down long enough for it to take effect. It has also been hours, during which there is impairment of cognitive func found that orally administered THC is erratically and slowly tions, perception, reaction time, learning and memory. These absorbed into the bloodstream, making the dose and duration side effects clearly have implications, such as for the opera of action difficult to control. Furthermore, the oral dose is less tion of machinery, and in particular for driving. These effects effective than Smoked Cannabis and therefore larger doses also make Cannabis less attractive for widespread, main are required in order to achieve a desired therapeutic effect. stream use, as it can reduce a patient’s ability to perform relatively simple tasks during treatment. SUMMARY 0007. The euphoric effects of Cannabis may also consti 0014. The present invention provides for a process for tute an undesirable side effect for patients using the drug for obtaining an extract of Cannabis. The process includes: (a) medicinal purposes, especially for "naive Cannabis users. contacting Cannabis plant material with a Supercritical fluid Furthermore, here have been reports of unpleasant reactions solvent system at a pressure between about 750 psi and to Cannabis, Such as anxiety, panic or hallucinations. It is 25,000 psi, and at a temperature between about -15° C. and believed that these undesirable effects are most commonly 200°C., to provide an extract of Cannabis; and (b) optionally associated with higher doses of Cannabis. removing the supercritical fluid solvent system from the 0008. Despite these effects, years of research have failed extract of Cannabis to provide a concentrate of Cannabis. to show that Cannabis is dangerous. In fact, the results appear 0015 The present invention provides for an additional to have proved the opposite. Cannabis has been shown to be process for obtaining an extract of Cannabis. The process safer, with fewer serious side effects than most prescription includes: (a) contacting Cannabis plant material with a Super drugs currently used as anti-emetics, muscle relaxants, hyp critical fluid solvent system at a pressure between about 750 notics and analgesics, etc. psi and 25,000 psi, and at a temperature between about -15° 0009. The physiological and pharmacological effects of C. and 200° C., to provide an extract of Cannabis and an Cannabis depend upon a number of factors, including the extracted Cannabis plant material; (b) removing the Super dosage level and the route of administration. critical fluid solvent system from the extract of Cannabis to 0010. There are currently two main methods of Cannabis provide a concentrate of Cannabis; (c) contacting the delivery. Lung delivery is most commonly achieved by Smok extracted Cannabis plant material with a second Supercritical US 2015/0297653 A1 Oct. 22, 2015 fluid solvent system at a pressure between about 750 psi and includes: (a) contacting Cannabis plant material with a Super 25,000 psi, and at a temperature between about -15° C. and critical fluid solvent system, at a pressure between about 750 200°C., to provide a second extract of Cannabis and a second psi and 25,000 psi, and at a temperature between about -15° extracted Cannabis plant material; and (d) optionally remov C. and 200° C., to provide an extract of Cannabis; and (b) ing the second Supercritical fluid solvent system from the removing the supercritical fluid solvent system from the second extract of Cannabis to provide a second concentrate of extract. The (a) contacting of the Cannabis plant material Cannabis. with the Supercritical fluid solvent system and the (b) remov 0016. The present invention provides for an additional ing the Supercritical fluid solvent system, is carried out mul process for obtaining an extract of Cannabis. The process tiple times, such that the process may be a fractional Super includes: (a) contacting Cannabis plant material with a Super critical fluid extraction. Additionally, each contacting of the critical fluid solvent system at a pressure between about 750 Cannabis plant material with a supercritical fluid solvent psi and 25,000 psi, and at a temperature between about -15° system independently occurs at a pressure between about 750 C. and 200° C., to provide an extract of Cannabis and an psi and 25,000 psi, and independently occurs at a temperature extracted Cannabis plant material; (b) removing the Super between about -15° C. and 200° C. critical fluid solvent system from the extract of Cannabis to 0019. The present invention also provides a pharmaceuti provide a concentrate of Cannabis; (c) contacting the cal dosage form, which can bean oral thin film (OTF) suitable extracted Cannabis plant material with a second Supercritical for oral delivery, or an adhesive topical patch suitable for fluid solvent system at a pressure between about 750 psi and transdermal delivery. The pharmaceutical dosage form 25,000 psi, and at a temperature between about -15° C.
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