HERBAL COMPOSITIONS OF CALIFORNIA POPPY AND METHOD FOR THE TREATMENT OF SLEEP AND DREAM-RELATED DISORDERS

Abstract

An herbal pharmaceutical compositions of California poppy and methods for the treatment of sleep disorders and dream-related disorders is disclosed. The formulation may be in the form of capsules, tablets, caplets or other oral dosage forms and comprises preferably 600 to 2400 mg of a ratio of 4-10 parts (wt) dried plant material to 1 part (wt) aqueous alcohol (50-90 vol % ethanol) extract that is equivalent to 3-12 grams of the dried herb top of California poppy and contain at least 0.8 wt % isoquinoline alkaloids. The composition may further comprise isoquinoline alkaloids whose composition contains Californidine, Escholtzine and Protopine. California poppy can also be used as a therapy for managing people that have sleep and dream disorders such as Post Traumatic Stress syndrome and similar conditions that induce nightmares as well as people using tranquilizer, antidepressant, antipsychotic, sedative, hypnotic and analgesic drugs.

Claims

1. An herbal pharmaceutical composition of California poppy (Eschscholzia californica Cham.) for the treatment of sleep disorders and/or dream-related disorders, the composition comprising an extract of dried herb top of California poppy having a ratio of 5 parts (wt) of dried plant material to 1 part (wt) of aqueous alcohol (50-90 vol % ethanol).

2. The herbal pharmaceutical composition of California poppy of claim 1, the extract comprising between 3 grams to 12 grams of dried plant material of California poppy.

3. The herbal pharmaceutical composition of California poppy of any of claim 1 or 2, the composition comprising 600 mg of the extract of dried herb top of California poppy.

4. The herbal pharmaceutical composition of California poppy of any one of claims 1 to 3, the composition further comprising at least 0.8 wt %, but not more than 1 wt %, isoquinoline alkaloids, the isoquinoline alkaloids comprising: Californidine (60.0-80.0 wt % total alkaloids); Escholtzine (10.0-30.0 wt % total alkaloids); and Protopine (3.0-10.0 wt % total alkaloids).

5. An herbal pharmaceutical composition of California poppy (Eschscholzia californica Cham.) for the treatment of sleep disorders and/or dream-related disorders, wherein said composition comprising at least between 600 to 2400 mg of an extract of California poppy having a ratio of between 4 to 10 parts (wt) dried plant material to 1 part (wt) aqueous alcohol (50-90 vol % ethanol).

6. The herbal pharmaceutical composition of California poppy of claim 5, the extract comprising between 3 grams to 12 grams of dried plant material of California poppy.

7. The herbal pharmaceutical composition of California poppy of any one of claim 5 or 6, the composition comprising at least 0.8 wt % isoquinoline alkaloids, the isoquinoline alkaloids comprising: Californidine (60.0-80.0 wt % total alkaloids); Escholtzine (10.0-30.0 wt % total alkaloids); and Protopine (3.0-10.0 wt % total alkaloids).

8. The herbal pharmaceutical composition of California poppy of any of claims 1 to 7, wherein the composition is in the form of capsules, tablets, caplets or other oral dosage forms.

9. Use of herbal pharmaceutical composition of California poppy (Eschscholzia californica Cham.) of any one of claims 1 to 6 for the treatment of sleep disorders and/or dream-related disorders.

10. The use of the herbal pharmaceutical composition of claim 9, wherein the sleep disorders and/or dream-related disorders are associated with Post Traumatic Stress syndrome and similar conditions that induce nightmares.

11. The use of the herbal pharmaceutical composition of claim 9, wherein the sleep disorders and/or dream-related disorders are associated with the use of tranquilizer, antidepressant, antipsychotic, sedative, hypnotic and analgesic drugs.

12. Use of California poppy (Eschscholzia californica Cham.) for the treatment of treatment for sleep disorders and/or dream-related disorders.

13. The use of the herbal pharmaceutical composition of claim 12, wherein the sleep disorders and/or dream-related disorders are associated with Post Traumatic Stress syndrome and similar conditions that induce nightmares.

14. The use of the herbal pharmaceutical composition of claim 12, wherein the sleep disorders and/or dream-related disorders are associated with the use of tranquilizer, antidepressant, antipsychotic, sedative, hypnotic and analgesic drugs.

15. A method for treating sleep disorders and/or dream-related disorders, the method comprising the step of administering a pharmaceutical composition as defined in any one of claims 1 to 8, the composition being in the form of a capsule.

16. The method of claim 15, wherein 2 capsules of the formulation are given before going to sleep.

17. The method of any one of claim 15 or 16, wherein the sleep disorders and/or dream-related disorders are associated with Post Traumatic Stress syndrome and similar conditions that induce nightmares.

18. The method of any one of claim 15 or 16, wherein the sleep disorders and/or dream-related disorders are associated with the use of tranquilizer, antidepressant, antipsychotic, sedative, hypnotic and analgesic drugs.

Description

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0034] A novel pharmaceutical composition will be described hereinafter. Although the invention is described in terms of specific illustrative embodiments, it is to be understood that the embodiments described herein are by way of example only and that the scope of the invention is not intended to be limited thereby.

[0035] It is disclosed herbal compositions of California poppy for the treatment of sleep and dream-related disorders.

[0036] According to a preferred embodiment, the formulation is in a form of Capsules, tablets, caplets or other oral dosage forms that preferably contain and or deliver 600 to 2400 mg of a ratio of 4-10 parts (wt) dried plant material to 1 part (wt) aqueous alcohol (50-90 vol % ethanol) extract that is equivalent to 3-12 grams of the dried herb top of California poppy and contain at least 0.8 wt % isoquinoline alkaloids (based on HPLC analysis). The composition of the isoquinoline alkaloids is: [0037] Californidine (60.0-80.0 wt % total alkaloids by HPLC) [0038] Escholtzine (10.0-30.0 wt % total alkaloids by HPLC) [0039] Protopine (3.0-10.0 wt % total alkaloids by HPLC)

[0040] According to a preferred embodiment, the formulation is CALPXT96 (formulation used in the ongoing trial; 2 capsules given at bedtime): Capsule that contains 600 mg of a ratio of 5 parts (wt) dried plant material to 1 part (wt) aqueous alcohol (50-90 vol % ethanol) extract that is equivalent to 3 grams of the dried herb top of California poppy and contains at least 0.8 wt %, but not more than 1 wt %, isoquinoline alkaloids (based on HPLC analysis). It has been discovered that these formulations alter the sleep pattern of the patient in such a way that the body will undergo a restorative sleep. This effect is characterized by changes in the dreaming of the patient; patient undergoes fantastic, pleasant or strange dreams.

[0041] Changes in the dreaming are associated with restorative sleep. The effect on the dreams is not caused by delusions or hallucinations induced by the herb formulation but by a pharmacological effect that acts on the sleep and dream patterns

[0042] According to the scientific/medical literature, 50% to 89% of chronic pain patients complain of poor sleep and/or feeling unrefreshed upon awakening (Okura et al. Sleep Medicine 2008; 9:352-361). Clinical studies have shown that pain interferes with sleep (Smith and Haythornthwaite. Sleep Med Rev 2004; 8:119-132) and that disturbed sleep lowers the pain threshold (Haack et al. Sleep 2007; 30:1145-1152; & Smith et al. Sleep 2007; 30:494-505; & Roehrs et al. Sleep 2006; 29:145-151.). It is also known that, in general, tranquilizers, antidepressants, antipsychotics, sedatives, hypnotics and analgesics decrease sleep in people. When California poppy is taken for sleep in people using tranquilizer, antidepressant, antipsychotic, sedative, hypnotic and analgesic drugs, the California poppy will still provide restorative sleep in these patients because it is not associated with drug's pharmacological mode of action; in other words, the restorative sleep is the not the result of an additive sedative, tranquilizing or hypnotic effect.

[0043] California poppy can be used as a therapy for managing people that have sleep and dream disorders such as Post Traumatic Stress syndrome and similar conditions that induce nightmares. The herb will act on the dream physiology to modify the imbalance and produce fantastic, pleasant or strange dreams that are not scary or traumatizing to the person.

[0044] While illustrative and presently preferred embodiments of the invention have been described in detail hereinabove, it is to be understood that the inventive concepts may be otherwise variously embodied and employed and that the appended claims are intended to be construed to include such variations except insofar as limited by the prior art.

REFERENCES

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