COMPOSITIONS AND METHODS USING CANNABINOIDS FOR TREATING STAMMERING/STUTTERING AND SYMPTOMS OF TOURETTE SYNDROME

Abstract

This invention relates to compositions and methods for treating stammering/stuttering and Tourette syndrome (TS) in humans, using a formulation comprising of a combination of a Cannabis compound, or compounds.

Claims

1. Composition for treating a patient suffering from stammering, stuttering or Tourette syndrome comprising THC in the range of about 0.2 μg/kg to about 0.035 mg/kg of patient weight or CBD in the range of about 0.2 μg/kg to about 0.035 mg/kg of patient weight.

2. Composition of claim 1 comprising the THC in the range of about 0.2 μg/kg to about 0.035 mg/kg of patient weight.

3. Composition of claim 1 comprising the CBD in the range of about 0.2 μg/kg to about 0.035 mg/kg of patient weight.

4. Composition of claim 1 wherein the THC is organic or synthetic.

5. Composition of claim 1 which includes an atypical antipsychotic drug selected from the group consisting of risperidone, clozapine, olanzapine, ziprasidone, tiapride, sulpiride, and aripiprazole in an amount that lowers the incidence of stammering.

6. Composition of claim 5 comprising the THC, the CBD, and the atypical antipsychotic drug is selected from the group consisting of risperidone, tiapride, sulpiride, and aripiprazole.

7. Composition of claim 6 in the form of oral drops or an oral spray.

8. Method for treating a patient suffering from stammering, stuttering or Tourette syndrome comprising administering to said patient a composition comprising THC in the range of about 0.2 μg/kg to about 0.035 mg/kg patient weight or CBD in the range of about 0.2 μg/kg to about 0.035 mg/kg patient weight.

9. Method according to claim 8 wherein said patient is orally administered the THC in a daily dose of up to about 2.5 mg.

10. Method according to claim 8 wherein said patient is orally administered the CBD in a daily dose of up to about 2.5 mg.

11. Method according to claim 8 wherein the THC is organic or synthetic.

12. Method according to claim 8 wherein said composition includes an atypical antipsychotic drug selected from the group consisting of risperidone, clozapine, olanzapine, ziprasidone, tiapride, sulpiride, and aripiprazole in an amount that lowers the incidence of stammering.

13. Method according to claim 12 wherein said patient is administered the THC in a daily dose of up to about 2.5 mg, the CBD in a daily dose of up to about 2.5 mg, and the atypical antipsychotic drug is selected from the group consisting of risperidone, tiapride, sulpiride, and aripiprazole.

14. Method according to claim 13 wherein said composition is orally administered.

Description

DESCRIPTION

[0014] Cannabis compounds can be synthetic (chemically synthesized) or extracted from Cannabis plants such as sativa, indica, or hemp or hybrid strains of sativa and indica. A preferred source of tetrahydrocannabinol (THC) is so-called organic THC, which is extracted from Cannabis and contains minor amounts of other cannabinoids such as CBD.

[0015] The preferred oral dose range comprising the formulation is set out in Table 1:

TABLE-US-00001 TABLE 1 Active ingredient Dose range per kg of body weight THC 0.2 μg/kg to about 0.035 mg/kg CBD 0.2 μg/kg to about 0.035 mg/kg

TABLE-US-00002 TABLE 2 Conversion of dose for a 70-kg human: Active ingredient Dose range per 70 kg of body weight THC 1.4 μg to about 2.5 mg CBD 1.4 μg to about 2.5 mg

[0016] The preferred oral dose is in the range of 1 ml of an oral suspension, for a 70-Kg human, twice a day, thrice a day or four times a day depending on the severity of the symptoms comprising of a Cannabis compound with up to 2.5 mg of THC, and up to 2.5 mg CBD.

[0017] The combination of lower dose of THC and CBD, compounds unexpectedly lead to a lower incidence of stammering and symptoms associated with TS.

[0018] Suitable pharmaceutically acceptable Cannabis compounds include Cannabis extract, which includes phytocannabinoids such as tetrahydrocannabinol “THC” (9-tetrahydrocannabinol (delta-9 THC), 8-tetrahydrocannabinol (delta-8 THC) and 9-THC acid), cannabidiol (CBD), other phytocannabinoids such as cannabinol (CBN), cannabichromene (CBC), cannabigerol (CBG) among others, terpenoids, and flavonoids. Standardized Cannabis extract (SCE) consists of mostly THC, CBD, and CBN. Organic THC consists of solvent extracted THC from Cannabis with lesser or trace amounts of other cannabinoids and terpenoids. Synthetic or pure THC, which is free of CBD and other compounds, is a preferred Cannabis compound.

[0019] THC and CBD can be extracted from a Cannabis indica dominant strain using, for example, high pressure and carbon dioxide or ethanol as a solvent in a 1500-20L subcritical/supercritical CO.sub.2 system made by Apeks Supercritical, 14381 Blamer Rd., Johnstown, Ohio, 43031.

Example 1

[0020] The following is a list of ingredients for making 30 ml of the formulation:

[0021] I. THC: 0.25%

[0022] II. CBD: 0.25%

[0023] III. Honey (organic): 20% ml

[0024] IV. Vitamin-E-TPGS: 2.5%

[0025] V. Rutin: 0.05%

[0026] VI. Coconut oil (organic): 0.5%

[0027] VII. USP Water: 80%

[0028] VIII. Ascorbic acid 1%

[0029] IX. Organic flavor: 0.05%

[0030] X. Beta-cyclodextrin: 0.5% [0031] Weigh 75 mg of each compound THC and CBD and dissolve in 150 mg of coconut oil using a mechanical stirrer for 6 minutes. To this add 150 mg of beta cyclodextrin and 0.750 g of Vitamin-E-TPGS and mix with a mechanical stirrer for 6 minutes. Label this solution as Solution A. [0032] In a separate beaker, weigh 0.3 g of ascorbic acid and add 24 ml of USP grade water and 6 ml honey. Stir this mixture using a mechanical stirrer for 10 minutes. Label this as Solution B. [0033] To Solution B, add 1.6 mg of Rutin and mechanically stir for 7 minutes. [0034] Filter Solution B through a 0.2-micron filter using a vacuum filtration unit. [0035] Mix Solution A and the Filtered Solution B together and mechanically stir for 15 minutes. [0036] The final solution is stored in a bottle away from direct sunlight at room temperature.

[0037] The Cannabis or hemp plant in its natural form contains THCA and CBDA. The resin called shatter is extracted from the Cannabis/hemp flower using any of a variety of methods including CO.sub.2 extraction as described herein. Shatter is produced using a three-step process: kief separation, extraction, and winterization. Cannabis flower is introduced into a steel tumbler over a mesh sieve with dry ice. Flower is frozen and broken while tumbled with dry ice chunks allowing fine THCA bearing particles (kief) to fall through the sieve. THCA is then extracted from kief using supercritical extraction. A solvent such as CO.sub.2 and kief are introduced into a chamber. That sealed chamber is pressurized to approximately 2800 psi and heated to 53° C. Supercritical CO.sub.2 is then allowed to flow out of the pressurized chamber into a vial at room temperature and pressure (while more CO.sub.2 is introduced to maintain pressure in the chamber). As the CO.sub.2 vaporizes in the collector vial, it deposits shatter. In the third, optional step, called winterization, the CO.sub.2 oil is dissolved in ethanol (¾ ounce shatter dissolved in 400 ml ethanol). This mixture is then poured through a filter (such as a coffee filter) frozen for 48 hours, then warmed, filtered again, and then spun with heat to evaporate off the ethanol. The remaining resin contains a combination of THCA, CBDA, and other Cannabis compounds. The resin is heated for 60 minutes at 240° F. An HPLC test is run to determine the amount of THC and CBD and THCA and CBDA present in the resin.

[0038] 75 mg of the resin containing 99% THC and CBD (as determined by HPLC) is dissolved in 150 mg of organic coconut oil. The dissolved resin is transferred and mixed with the solution of -honey-ascorbic acid-rutin-vitamin-E-TPGS. The solution is filtered and sterilized using a 0.2-micron PES Nalgene filtration unit under constant pressure in a sterilized environment. The filtered 30 ml solution is transferred to and stored in an amber glass bottle that is autoclaved in an aseptic condition.

Example 2

[0039] A TS patient exhibiting multiple motor and vocal tics an hour is given 1 ml of the formulation of Example 1, in the morning on an empty stomach, prior to breakfast, and 1 ml prior to dinner in the evening. The patient after three days of therapy exhibits reduced motor and vocal tics with no side effects commonly associated with Cannabis.

Example 3

[0040] A stuttering patient exhibiting continuous conversational stuttering is given 1 ml of the formulation of Example 1, in the morning on an empty stomach, prior to breakfast, and 1 ml prior to dinner in the evening. The patient exhibits reduced vocal stuttering.

Example 4

[0041] A patient exhibiting conversational stuttering during stress is given 1 ml of the formulation of Example 1 via a spray prior to the onset of stress. The patient exhibits reduced vocal stuttering and manages to have a near stuttering free conversation.

Example 5

[0042] A patient with advance stage TS exhibiting moderate to severe anxiety, sleep disorder and/or multiple motor tics and several vocal (phonic) conversational stuttering is given 1 ml of the formulation of Example 1 three times a day, morning afternoon and evening, prior to meals. The patient exhibits reduced anxiety and agitation and caregiver distress.

Example 6

[0043] The formulation of Example 1, without the THC component, is administered three times a day prior to meals to a moderate stage attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder (OCD), self-injurious behavior, depression, and anxiety disorder with a decrease in all symptoms.

Example 7

[0044] A male patient displaying stammering and taking standard atypical anti-psychotic drug treatment. The said patient is administered the formulation of Example 1 without the CBD component which over three days leads to a decrease in the anti-psychotic medication and associated side effects of the atypical anti-psychotic drug medication.

Example 8

[0045] A patient displaying stammering and taking standard atypical anti-psychotic drug is administered the formulation of Example 1 without the THC component. Over three days the patient exhibits a decrease in the atypical anti-psychotic drug medication and associated side effects of the anti-psychotic drug medication.

Example 9

[0046] A male patient age 17 displaying stammering and on standard atypical anti-psychotic drug is administered the formulation of Example 1 without THC. The patient, after 5 days of treatment, exhibits a decrease in the atypical anti-psychotic medication and associated side effects of the anti-psychotic drug medication.

Example 10

[0047] A male patient age 14 displays stammering as measured on the Speech Efficiency Score (SES) scale of 11. The patient is administered the formulation of Example 1 without the THC component. After a period of two weeks the patient exhibits an SES score of 6.