Pharmaceutical compositions of psilocin and uses thereof

Abstract

The present invention relates to pharmaceutically acceptable salts of psilocin, methods of preparation thereof and uses thereof in therapy.

Description

[0001] PHARMACEUTICAL COMPOSITIONS OF PSILOCIN AND USES THEREOF

[0002] BACKGROUND

[0003] Significant interest in the therapeutic application of psilocin has developed, based upon evidence of possible therapeutic effects in a wide array of clinical applications, including psychiatric conditions, pain disorders, and neurological conditions. However, there remains a need in the art for the provision of improved pharmaceutical compositions, in particular free-flowing dry powder intranasal compositions, and uses thereof.

[0004] SUMMARY OF THE INVENTION

[0005] Psilocin has the structure:

[0006] Psilocybin is a phosphate prodrug for psilocin, and when administered to a subject, psilocybin is metabolized to form psilocin. Psilocybin undergoes an enzymatic dephosphorylation reaction resulting in a loss of the phosphate group revealing psilocin’s hydroxy group. Psilocybin exists as a zwitterion in which the phosphate and amine ionize each other. The existence of a zwitterion limits the solubility of psilocybin and also curtails its ability to make a salt with an alternate acid that could exist under physiologically tolerated conditions. Removing the phosphate group allows the formation of alternate acid salt forms of psilocin’s dimethylamine that are not possible to be prepared with psilocybin. Being able to exist in a nonionized form, Psilocin is much more lipid soluble in comparison to psilocybin and therefore is capable of crossing the blood brain barrier more effectively to elicit a response. Psilocin has a high affinity for and is able to activate the 5-HT2A receptor, which plays a key role in regulating mood, sexual behavior, aggression, impulsivity, cognitive function, appetite, pain, sleep, and memory along with other behaviors. As a result, psilocin has effects at 5-HT2A receptor that mimic the action of the endogenous neurotransmitter serotonin. This disclosure provides therapeutically effective doses of psilocin, and compositions thereof, that are useful in therapy, such as in the treatment of a patient having a psychological condition or a neurological injury.

[0007] In an embodiment, there is provided a pharmaceutical composition comprising psilocin benzoate and magnesium stearate.

[0008] In an embodiment, the composition comprises from about 0.1 % w / w to about 10% w / w magnesium stearate. In an embodiment, the composition comprises from about 0.5% w / w to about 5% w / w magnesium stearate. In an embodiment, the composition comprises about 1 % w / w of magnesium stearate.

[0009] In an embodiment, the composition is a dry powder composition. In an embodiment, the composition is a dry blended dry powder composition. In an embodiment, the composition is a free-flowing pharmaceutical composition. In an embodiment, the composition is a free-flowing dry powder pharmaceutical composition. In an embodiment, the composition is a free-flowing dry blended dry powder pharmaceutical composition.

[0010] In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60- 140 mPa«s, wherein the cellulose-based excipient has a viscosity of 80-120 mPa«s. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient has a viscosity of 100 mPa«s.

[0011] In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose.

[0012] In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.ln an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s. In an embodiment, the pharmaceutical composition comprises a cellulose- based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s. In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 2- 10, 3-9, 4-8, 6 or 7 mPa«s.

[0013] In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s. In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s. In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient and wherein the cellulose-based excipient is hydroxypropyl methyl cellulose (HPMC).

[0014] In an embodiment, the pharmaceutical composition comprises about 15% to about 60% w / w psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 20% to about 55% w / w psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 25% to about 50% w / w psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 10 mg psilocin freebase equivalent of psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 8 mg psilocin freebase equivalent of psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 4 mg psilocin freebase equivalent of psilocin benzoate.

[0015] In an embodiment, the pharmaceutical composition comprises 25% w / w psilocin benzoate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0016] In an embodiment, the pharmaceutical composition is substantially free of particles smallerthan 10 microns, optionally in diameter. In an embodiment, the pharmaceutical composition is substantially free of respirable fines. In an embodiment, 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are largerthan 10 microns. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80-120pm, and / or d90=130-300pm.

[0017] In an embodiment, the pharmaceutical composition is a dry blended dry powder pharmaceutical composition and comprises: magnesium stearate; psilocin benzoate; a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

[0018] In an embodiment, there is provided a pharmaceutical composition comprising psilocin tartrate and sodium stearyl fumarate. In an embodiment, the composition comprises from about 0.1 % w / w to about 10% w / w of sodium stearyl fumarate. In an embodiment, the composition comprises from about 0.1 % w / w to about 5% w / w of sodium stearyl fumarate. In an embodiment, the composition comprises from about 0.5% w / w to about 5% w / w of sodium stearyl fumarate. In an embodiment, the composition comprises from about 1 % w / w to about 3% w / w of sodium stearyl fumarate. In an embodiment, the composition comprises about 1 % w / w of sodium stearyl fumarate.

[0019] In an embodiment, the composition is a dry powder composition. In an embodiment, the composition is a dry blended dry powder composition. In an embodiment, the composition is a free-flowing pharmaceutical composition. In an embodiment, the composition is a free-flowing dry powder pharmaceutical composition. In an embodiment, the composition is a free-flowing dry blended dry powder pharmaceutical composition.

[0020] In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60- 140 mPa«s, wherein the cellulose-based excipient has a viscosity of 80-120 mPa«s. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient has a viscosity of 100 mPa«s. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose.

[0021] In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose.

[0022] In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s. In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s. In an embodiment, the pharmaceutical composition comprises a cellulose- based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s. In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 2- 10, 3-9, 4-8, 6 or 7 mPa«s.

[0023] In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s. In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s.

[0024] In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient and wherein the cellulose-based excipient is hydroxypropyl methyl cellulose (HPMC).

[0025] In an embodiment, the pharmaceutical composition comprises about 15% to about 60% w / w psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 20% to about 55% w / w psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 25% to about 50% w / w psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin tartrate.

[0026] In an embodiment, the pharmaceutical composition comprises about 1 mg to about 10 mg psilocin freebase equivalent of psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 8 mg psilocin freebase equivalent of psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 6 mg psilocin freebase equivalent of psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 6 mg psilocin freebase equivalent of psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 4 mg psilocin freebase equivalent of psilocin tartrate.

[0027] In an embodiment, the pharmaceutical composition comprises 25% w / w psilocin tartrate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0028] In an embodiment, the pharmaceutical composition is substantially free of particles smallerthan 10 microns, optionally in diameter. In an embodiment, the pharmaceutical composition is substantially free of respirable fines. In an embodiment, 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are largerthan 10 microns. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80-120pm, and / or d90=130-300pm.

[0029] In an embodiment, the pharmaceutical composition is a dry blended dry powder pharmaceutical composition and comprises: sodium stearyl fumarate; psilocin tartrate; a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

[0030] In an embodiment, the pharmaceutical composition is crystalline. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below:

[0031] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.5, 10.9±0.5, 12.3±0.5, 13.3±0.5, 14.5±0.5, 15.3±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5, 19.7±0.5, 20.0±0.5, 20.8±0.5, 21.3±0.5, 21.9±0.5, 22.6±0.5, 22.9±0.5, 23.8±0.5, 24.1 ±0.5, 24.9±0.5, 25.6±0.5, 26.0±0.5, 26.3±0.5,

[0032] 26.5±0.5, 26.9±0.5, 27.5±0.5, and 28.5±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.4, 10.9±0.4, 12.3±0.4, 13.3±0.4, 14.5±0.4, 15.3±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4, 19.7±0.4, 20.0±0.4, 20.8±0.4, 21.3±0.4, 21.9±0.4, 22.6±0.4, 22.9±0.4, 23.8±0.4, 24.1 ±0.4, 24.9±0.4, 25.6±0.4, 26.0±0.4, 26.3±0.4,

[0033] 26.5±0.4, 26.9±0.4, 27.5±0.4, and 28.5±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.3, 10.9±0.3, 12.3±0.3, 13.3±0.3,

[0034] 14.5±0.3, 15.3±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, 19.7±0.3, 20.0±0.3, 20.8±0.3,

[0035] 21.3±0.3, 21.9±0.3, 22.6±0.3, 22.9±0.3, 23.8±0.3, 24.1 ±0.3, 24.9±0.3, 25.6±0.3, 26.0±0.3, 26.3±0.3,

[0036] 26.5±0.3, 26.9±0.3, 27.5±0.3, and 28.5±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of

[0037] 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.2, 10.9±0.2, 12.3±0.2, 13.3±0.2, 14.5±0.2, 15.3±0.2, 16.3±0.2, 16.4±0.2, 18.2±0.2, 18.9±0.2, 19.3±0.2, 19.7±0.2, 20.0±0.2, 20.8±0.2, 21.3±0.2, 21.9±0.2, 22.6±0.2, 22.9±0.2, 23.8±0.2, 24.1 ±0.2, 24.9±0.2, 25.6±0.2, 26.0±0.2, 26.3±0.2, 26.5±0.2, 26.9±0.2, 27.5±0.2, and 28.5±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of

[0038] 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.1 , 10.9±0.1 , 12.3±0.1 , 13.3±0.1 , 14.5±0.1 , 15.3±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , 19.7±0.1 , 20.0±0.1 , 20.8±0.1 , 21.3±0.1 , 21.9±0.1 , 22.6±0.1 , 22.9±0.1 , 23.8±0.1 , 24.1 ±0.1 , 24.9±0.1 , 25.6±0.1 , 26.0±0.1 , 26.3±0.1 , 26.5±0.1 , 26.9±0.1 , 27.5±0.1 , and 28.5±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of

[0039] 1.5406 A.

[0040] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.5, 18.2±0.5, and 18.9±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 18.2±0.5, 18.9±0.5 and 19.3±0.5 (BEN Pattern 1) as measured using an x- ray wavelength of 1 .5406 A.

[0041] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5 and 19.7±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.4, 18.2±0.4, and 18.9±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0042] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 18.2±0.4, 18.9±0.4 and 19.3±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4 and 19.7±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0043] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.3, 18.2±0.3, and 18.9±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 18.2±0.3, 18.9±0.3, and 19.3±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0044] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, and 19.7±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.2, 18.2±0.2, and 18.9±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0045] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.2, 16.3±0.2, 18.2±0.2, 18.9±0.2, and 19.3±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0046] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.1 , 18.2±0.1 , and 18.9±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 18.2±0.1 , 18.9±0.1 and 19.3±0.1 (BEN Pattern 1) as measured using an x- ray wavelength of 1 .5406 A.

[0047] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0048] In an embodiment, the pharmaceutical composition is crystalline. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below:

[0049] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.5, 12.6±0.5, 13.4±0.5, 14.7±0.5, 15.8±0.5, 16.2±0.5, 17.2±0.5, 18.8±0.5, 19.9±0.5, 20.8±0.5, 21.8±0.5, 22.5±0.5, 23.4±0.5, 23.7±0.5, 24.7±0.5, 25.5±0.5, 26.5±0.5, 27.0±0.5, 28.5±0.5, and 29.4±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.4, 12.6±0.4, 13.4±0.4, 14.7±0.4, 15.8±0.4, 16.2±0.4, 17.2±0.4, 18.8±0.4, 19.9±0.4, 20.8±0.4, 21.8±0.4, 22.5±0.4, 23.4±0.4, 23.7±0.4, 24.7±0.4, 25.5±0.4, 26.5±0.4, 27.0±0.4, 28.5±0.4, and 29.4±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0050] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.3, 12.6±0.3, 13.4±0.3, 14.7±0.3, 15.8±0.3, 16.2±0.3, 17.2±0.3, 18.8±0.3, 19.9±0.3, 20.8±0.3, 21.8±0.3, 22.5±0.3, 23.4±0.3, 23.7±0.3, 24.7±0.3, 25.5±0.3, 26.5±0.3, 27.0±0.3, 28.5±0.3, and 29.4±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.2, 12.6±0.2, 13.4±0.2, 14.7±0.2, 15.8±0.2, 16.2±0.2, 17.2±0.2, 18.8±0.2, 19.9±0.2, 20.8±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.7±0.2, 24.7±0.2, 25.5±0.2, 26.5±0.2, 27.0±0.2, 28.5±0.2, and 29.4±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0051] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.1 , 12.6±0.1 , 13.4±0.1 , 14.7±0.1 , 15.8±0.1 , 16.2±0.1 , 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 20.8±0.1 , 21.8±0.1 , 22.5±0.1 , 23.4±0.1 , 23.7±0.1 , 24.7±0.1 , 25.5±0.1 , 26.5±0.1 , 27.0±0.1 , 28.5±0.1 , and 29.4±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, 21 .8±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0052] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, 21 .8±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0053] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, 21 ,8±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, 21.8±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0054] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 21 ,8±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, there is provided a pharmaceutical composition comprising psilocin, or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose.

[0055] In an embodiment, the pharmaceutical composition comprises crystalline psilocin, or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose. In an embodiment, the pharmaceutical composition comprises about 0.1% w / w to about 10% w / w microcrystalline cellulose. In an embodiment, the pharmaceutical composition comprises about 0.5% w / w to about 9% w / w microcrystalline cellulose. In an embodiment, the pharmaceutical composition comprises about 1% w / w to about 8% w / w microcrystalline cellulose. In an embodiment, the pharmaceutical composition comprises about 2% w / w to about 7% w / w microcrystalline cellulose.

[0056] In an embodiment, the pharmaceutical composition comprises about 3% w / w to about 6% w / w microcrystalline cellulose. In an embodiment, the pharmaceutical composition comprises about 4% w / w to about 5% w / w microcrystalline cellulose. In an embodiment, the pharmaceutical composition comprises about 5% w / w microcrystalline cellulose.

[0057] In an embodiment, the composition is a dry powder composition. In an embodiment, the composition is a dry blended dry powder composition. In an embodiment, the composition is a free-flowing pharmaceutical composition. In an embodiment, the composition is a free-flowing dry powder pharmaceutical composition. In an embodiment, the composition is a free-flowing dry blended dry powder pharmaceutical composition. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s.

[0058] In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient has a viscosity of 80-120 mPa«s. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient has a viscosity of 100 mPa«s.

[0059] In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose.

[0060] In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose. In an embodiment, the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose. In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s. In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20,

[0061] 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s. In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0062] In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20,

[0063] 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s. In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s. In an embodiment, the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25,

[0064] 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s.

[0065] In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient and wherein the cellulose-based excipient is hydroxypropyl methyl cellulose (HPMC). In an embodiment, the pharmaceutical composition comprises about 15% to about 60% w / w psilocin benzoate or psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 20% to about 55% w / w psilocin benzoate or psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 25% to about 50% w / w psilocin benzoate or psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin benzoate or psilocin tartrate.

[0066] In an embodiment, the pharmaceutical composition comprises about 1 mg to about 10 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 8 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 4 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate.

[0067] In an embodiment, the pharmaceutical composition comprises 25% w / w psilocin benzoate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0068] In an embodiment, the pharmaceutical composition is substantially free of particles smaller than 10 microns, optionally in diameter.ln an embodiment, the pharmaceutical composition is substantially free of respirable fines. In an embodiment, 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are larger than 10 microns. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80-120pm, and / or d90=130-300pm.

[0069] In an embodiment, the pharmaceutical composition is a dry blended dry powder pharmaceutical composition and comprises: microcrystalline cellulose; psilocin benzoate or psilocin tartrate; a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below:

[0070] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.5, 10.9±0.5, 12.3±0.5, 13.3±0.5, 14.5±0.5, 15.3±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5, 19.7±0.5, 20.0±0.5, 20.8±0.5, 21.3±0.5, 21.9±0.5, 22.6±0.5, 22.9±0.5, 23.8±0.5, 24.1 ±0.5, 24.9±0.5, 25.6±0.5, 26.0±0.5, 26.3±0.5, 26.5±0.5, 26.9±0.5, 27.5±0.5, and 28.5±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of

[0071] 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.4, 10.9±0.4, 12.3±0.4, 13.3±0.4, 14.5±0.4, 15.3±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4, 19.7±0.4, 20.0±0.4, 20.8±0.4, 21.3±0.4, 21.9±0.4, 22.6±0.4, 22.9±0.4, 23.8±0.4, 24.1 ±0.4, 24.9±0.4, 25.6±0.4, 26.0±0.4, 26.3±0.4, 26.5±0.4, 26.9±0.4, 27.5±0.4, and 28.5±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of

[0072] 1 .5406 A.

[0073] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.3, 10.9±0.3, 12.3±0.3, 13.3±0.3, 14.5±0.3, 15.3±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, 19.7±0.3, 20.0±0.3, 20.8±0.3, 21.3±0.3, 21.9±0.3, 22.6±0.3, 22.9±0.3, 23.8±0.3, 24.1 ±0.3, 24.9±0.3, 25.6±0.3, 26.0±0.3, 26.3±0.3, 26.5±0.3, 26.9±0.3, 27.5±0.3, and 28.5±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of

[0074] 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.2, 10.9±0.2, 12.3±0.2, 13.3±0.2, 14.5±0.2, 15.3±0.2, 16.3±0.2, 16.4±0.2, 18.2±0.2, 18.9±0.2, 19.3±0.2, 19.7±0.2, 20.0±0.2, 20.8±0.2, 21.3±0.2, 21.9±0.2, 22.6±0.2, 22.9±0.2, 23.8±0.2, 24.1 ±0.2, 24.9±0.2, 25.6±0.2, 26.0±0.2, 26.3±0.2, 26.5±0.2, 26.9±0.2, 27.5±0.2, and 28.5±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of

[0075] 1 .5406 A.

[0076] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.1 , 10.9±0.1 , 12.3±0.1 , 13.3±0.1 ,

[0077] 14.5±0.1 , 15.3±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , 19.7±0.1 , 20.0±0.1 , 20.8±0.1 ,

[0078] 21.3±0.1 , 21.9±0.1 , 22.6±0.1 , 22.9±0.1 , 23.8±0.1 , 24.1 ±0.1 , 24.9±0.1 , 25.6±0.1 , 26.0±0.1 , 26.3±0.1 ,

[0079] 26.5±0.1 , 26.9±0.1 , 27.5±0.1 , and 28.5±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of

[0080] 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.5, 18.2±0.5, and 18.9±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0081] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 18.2±0.5, 18.9±0.5 and 19.3±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5 and 19.7±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0082] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.4, 18.2±0.4, and 18.9±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 18.2±0.4, 18.9±0.4 and 19.3±0.4 (BEN Pattern 1) as measured using an x- ray wavelength of 1 .5406 A.

[0083] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4 and 19.7±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.3, 18.2±0.3, and 18.9±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0084] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 18.2±0.3, 18.9±0.3, and 19.3±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, and 19.7±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0085] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.2, 18.2±0.2, and 18.9±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.2, 16.3±0.2, 18.2±0.2, 18.9±0.2, and 19.3±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0086] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.1 , 18.2±0.1 , and 18.9±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0087] In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 18.2±0.1 , 18.9±0.1 and 19.3±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. In an embodiment, the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0088] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below:

[0089] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.5, 12.6±0.5, 13.4±0.5, 14.7±0.5, 15.8±0.5, 16.2±0.5, 17.2±0.5, 18.8±0.5, 19.9±0.5, 20.8±0.5, 21.8±0.5, 22.5±0.5, 23.4±0.5, 23.7±0.5, 24.7±0.5, 25.5±0.5, 26.5±0.5, 27.0±0.5, 28.5±0.5, and 29.4±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.4, 12.6±0.4, 13.4±0.4, 14.7±0.4, 15.8±0.4, 16.2±0.4, 17.2±0.4, 18.8±0.4, 19.9±0.4, 20.8±0.4, 21.8±0.4, 22.5±0.4, 23.4±0.4, 23.7±0.4, 24.7±0.4, 25.5±0.4, 26.5±0.4, 27.0±0.4, 28.5±0.4, and 29.4±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0090] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.3, 12.6±0.3, 13.4±0.3, 14.7±0.3, 15.8±0.3, 16.2±0.3, 17.2±0.3, 18.8±0.3, 19.9±0.3, 20.8±0.3, 21.8±0.3, 22.5±0.3, 23.4±0.3, 23.7±0.3, 24.7±0.3, 25.5±0.3, 26.5±0.3, 27.0±0.3, 28.5±0.3, and 29.4±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.2, 12.6±0.2, 13.4±0.2, 14.7±0.2, 15.8±0.2, 16.2±0.2, 17.2±0.2, 18.8±0.2, 19.9±0.2, 20.8±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.7±0.2, 24.7±0.2, 25.5±0.2, 26.5±0.2, 27.0±0.2, 28.5±0.2, and 29.4±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0091] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.1 , 12.6±0.1 , 13.4±0.1 , 14.7±0.1 , 15.8±0.1 , 16.2±0.1 , 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 20.8±0.1 , 21.8±0.1 , 22.5±0.1 , 23.4±0.1 , 23.7±0.1 , 24.7±0.1 , 25.5±0.1 , 26.5±0.1 , 27.0±0.1 , 28.5±0.1 , and 29.4±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0092] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, 21 .8±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0093] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0094] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, 21 ,8±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0095] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, 21 .8±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0096] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, 21 ,8±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0097] In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. In an embodiment, the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 21 .8±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0098] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein. In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the composition is administered:

[0099] Intransally;

[0100] Via inhalation;

[0101] Intravenously;

[0102] Intramuscularly; or

[0103] Subcutaneously.

[0104] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the disease or condition is selected from one or more of: major depressive disorder (MDD), moderate to severe MDD, treatment-resistant MDD, major depression, melancholic depression, atypical depression, dysthymia, anxiety, treatment-resistant anxiety, end of life anxiety, generalised anxiety disorder, panic disorder, social anxiety, post-traumatic stress disorder, acute stress disorder, obsessive compulsive disorder, social phobia, substance abuse, alcoholism, tobacco abuse, drug abuse, anorexia nervosa, bulimia nervosa, binge eating disorder, primary impulse-control disorders, and obsessive-compulsive disorder. In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method comprises the administration of the pharmaceutical composition without concomitant treatment with one or more further active agents, optionally without concomitant treatment with one or more further active agents selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound; optionally wherein the subject discontinues treatment with the one or more further active agents prior to undergoing treatment with the pharmaceutical composition.

[0105] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents.

[0106] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound.

[0107] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex), Fluoxetine (Prozac, Sarafem), Fluvoxamine (Luvox, Faverin), Paroxetine (Paxil, Seroxat), Sertraline (Zoloft, Lustral), Desvenlafaxine (Pristiq), Duloxetine (Cymbalta), Levomilnacipran (Fetzima), Milnacipran (Ixel, Savella), Venlafaxine (Effexor), Vilazodone (Viibryd), Vortioxetine (Trintellix), Nefazodone (Dutonin, Nefadar, Serzone), Trazodone (Desyrel), Reboxetine (Edronax), Teniloxazine (Lucelan, Metatone), Viloxazine (Vivalan), Bupropion (Wellbutrin), Amitriptyline (Elavil, Endep), Amitriptylinoxide (Amioxid, Ambivalon, Equilibria), Clomipramine (Anafranil), Desipramine (Norpramin, Pertofrane), Dibenzepin (Noveril, Victoril), Dimetacrine (Istonil), Dosulepin (Prothiaden), Doxepin (Adapin, Sinequan), Imipramine (Tofranil), Lofepramine (Lomont, Gamanil), Melitracen (Dixeran, Melixeran, Trausabun), Nitroxazepine (Sintamil), Nortriptyline (Pamelor, Aventyl), Noxiptiline (Agedal, Elronon, Nogedal), Opipramol (Insidon), Pipofezine (Azafen / Azaphen), Protriptyline (Vivactil), Trimipramine (Surmontil), Amoxapine (Asendin), Maprotiline (Ludiomil), Mianserin (Tolvon), Mirtazapine (Remeron), Setiptiline (Tecipul), Isocarboxazid (Marplan), Phenelzine (Nardil), Tranylcypromine (Parnate), Selegiline (Eldepryl, Zelapar, Emsam), Caroxazone (Surodil, Timostenil), Metralindole (Inkazan), Moclobemide (Aurorix, Manerix), Pirlindole (Pirazidol), Toloxatone (Humoryl), Agomelatine (Valdoxan), Esketamine (Spravato), Ketamine (Ketalar), Tandospirone (Sediel), Tianeptine (Stabion, Coaxil), Amisulpride (Solian), Aripiprazole (Ability), Brexpiprazole (Rexulti), Lurasidone (Latuda), Olanzapine (Zyprexa), Quetiapine (Seroquel), Risperidone (Risperdal), Trifluoperazine (Stelazine), Buspirone (Buspar), Lithium (Eskalith, Lithobid), Modafinil (Provigil), Thyroxine (T4) and / or Triiodothyronine (T3).

[0108] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are one or more SSRIs.

[0109] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: citalopram, escitalopram, sertraline, fluoxetine, paroxetine or vilazodone.

[0110] In an embodiment, the one or more further active agents is 10, 20, 30 or 40 mg once daily of citalopram. In an embodiment, the one or more further active agents is 10 or 20 mg once daily of escitalopram. In an embodiment, the one or more further active agents is 50, 100, 150 or 200 mg once daily of sertraline. In an embodiment, the one or more further active agents is 10, 20, 30, 40, 50 or 60 mg once daily of fluoxetine. In an embodiment, the one or more further active agents is 10, 20, 30 or 40 mg once daily of paroxetine. In an embodiment, the one or more further active agents is 10, 20, 30 or 40 mg once daily of vilazodone.

[0111] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method of treatment comprises the provision of psychological support to the patient.

[0112] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method of treatment comprises the provision of psychological support to the patient prior to administration of the pharmaceutical composition.

[0113] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method of treatment comprises the provision of psychological support to the patient following administration of the pharmaceutical composition.

[0114] In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method of treatment is a method of treatment of moderate to severe major depressive disorder (MDD). In an embodiment, there is provided a pharmaceutical composition for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a composition as described herein, wherein the method of treatment is a method of treatment of a patient who is diagnosed with major depressive disorder, or moderate to severe major depressive disorder (MDD), by a licensed professional in accordance with accepted medical practice.

[0115] In an embodiment, there is provided a pharmaceutical composition, and uses as described herein thereof, comprising psilocin, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition comprises between about 10% and about 90%, between about 15% and about 85%, between about 20% and about 80%, between about 25% and about 75%, between about 30% and about 70%, between about 35% and about 65%, between about 40% and about 60% or between about 45% and about 55% w / w of psilocin, or a pharmaceutically acceptable salt thereof.

[0116] In an embodiment, there is provided a pharmaceutical composition, and uses as described herein thereof, comprising psilocin, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition comprises between about 10% and about 55%, between about 15% and about 54%, between about 20% and about 53%, between about 25% and about 52%, between about 30% and about 51 or between about 35% and about 50% w / w of psilocin, or a pharmaceutically acceptable salt thereof.

[0117] In an embodiment, there is provided a pharmaceutical composition, and uses as described herein thereof, comprising psilocin benzoate and kaolin. In an embodiment, there is provided a pharmaceutical composition, and uses as described herein thereof, comprising psilocin tartrate and mannitol.

[0118] In an embodiment, there is provided a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin, or a pharmaceutical acceptable salt thereof, and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s.

[0119] In an embodiment, the cellulose-based excipient has a viscosity of 80-120 mPa«s. In an embodiment, the cellulose-based excipient has a viscosity of 100 mPa«s. In an embodiment, the cellulose-based excipient has a viscosity of at least 6 mPa«s.

[0120] In an embodiment, the cellulose-based excipient is methylcellulose. In an embodiment, the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose. In an embodiment, the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose. In an embodiment, the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose. In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s. In an embodiment, the pharmaceutical composition comprises about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s. In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s. In an embodiment, the pharmaceutical composition comprises about 62.5% w / w of a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s. In an embodiment, the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s. In an embodiment, the pharmaceutical composition comprises about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s. In an embodiment, the cellulose-based excipient is hydroxypropyl methyl cellulose (HPMC).

[0121] In an embodiment, the pharmaceutical composition comprises about 15% to about 60% w / w psilocin or a pharmaceutically acceptable salt thereof. In an embodiment, the pharmaceutical composition comprises about 20% to about 55% w / w psilocin or a pharmaceutically acceptable salt thereof. In an embodiment, the pharmaceutical composition comprises about 25% to about 50% w / w psilocin or a pharmaceutically acceptable salt thereof. In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin or a pharmaceutically acceptable salt thereof.

[0122] In an embodiment, the pharmaceutical composition comprises about 1 mg to about 10 mg of psilocin freebase or about 1 mg to about 10 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 8 mg of psilocin freebase or about 1 mg to about 8 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin. In an embodiment, the pharmaceutical composition comprises about 1 mg to about 6 mg of psilocin freebase or about 1 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 6 mg of psilocin freebase or about 2 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin. In an embodiment, the pharmaceutical composition comprises about 2 mg to about 4 mg of psilocin freebase or about 2 mg to about 4 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0123] In an embodiment, the pharmaceutical composition comprises psilocin benzoate. In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin benzoate, about 12.5% w / w methylcellulose and about 62.5% HPMC. In an embodiment, the pharmaceutical composition comprises 25% w / w psilocin benzoate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0124] In an embodiment, the pharmaceutical composition comprises psilocin tartrate. In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin tartrate, about 12.5% w / w methylcellulose and about 62.5% HPMC. In an embodiment, the pharmaceutical composition comprises 25% w / w psilocin tartrate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0125] In an embodiment, the disease or condition is selected from one or more of: major depressive disorder (MDD), moderate to severe MDD, treatment-resistant MDD, major depression, melancholic depression, atypical depression, dysthymia, anxiety, treatment-resistant anxiety, end of life anxiety, generalised anxiety disorder, panic disorder, social anxiety, post-traumatic stress disorder, acute stress disorder, obsessive compulsive disorder, social phobia, substance abuse, alcoholism, tobacco abuse, drug abuse, anorexia nervosa, bulimia nervosa, binge eating disorder, primary impulse-control disorders, and obsessive- compulsive disorder.

[0126] In an embodiment, the method comprises the administration of the pharmaceutical composition without concomitant treatment with one or more further active agents, optionally without concomitant treatment with one or more further active agents selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound; optionally wherein the subject discontinues treatment with the one or more further active agents prior to undergoing treatment with the pharmaceutical composition.

[0127] In an embodiment, the method comprises the administration of the pharmaceutical composition alongside one or more further active agents. In an embodiment, the one or more further active agents are selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound. In an embodiment, the one or more further active agents are selected from: Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex), Fluoxetine (Prozac, Sarafem), Fluvoxamine (Luvox, Faverin), Paroxetine (Paxil, Seroxat), Sertraline (Zoloft, Lustral), Desven lafaxine (Pristiq), Duloxetine (Cymbalta), Levomilnacipran (Fetzima), Milnacipran (Ixel, Savella), Venlafaxine (Effexor), Vilazodone (Viibryd), Vortioxetine (Trintellix), Nefazodone (Dutonin, Nefadar, Serzone), Trazodone (Desyrel), Reboxetine (Edronax), Teniloxazine (Lucelan, Metatone), Viloxazine (Vivalan), Bupropion (Wellbutrin), Amitriptyline (Elavil, Endep), Amitriptylinoxide (Amioxid, Ambivalon, Equilibria), Clomipramine (Anafranil), Desipramine (Norpramin, Pertofrane), Dibenzepin (Noveril, Victoril), Dimetacrine (Istonil), Dosulepin (Prothiaden), Doxepin (Adapin, Sinequan), Imipramine (Tofranil), Lofepramine (Lomont, Gamanil), Melitracen (Dixeran, Melixeran, Trausabun), Nitroxazepine (Sintamil), Nortriptyline (Pamelor, Aventyl), Noxiptiline (Agedal, Elronon, Nogedal), Opipramol (Insidon), Pipofezine (Azafen / Azaphen), Protriptyline (Vivactil), Trimipramine (Surmontil), Amoxapine (Asendin), Maprotiline (Ludiomil), Mianserin (Tolvon), Mirtazapine (Remeron), Setiptiline (Tecipul), Isocarboxazid (Marplan), Phenelzine (Nardil), Tranylcypromine (Parnate), Selegiline (Eldepryl, Zelapar, Emsam), Caroxazone (Surodil, Timostenil), Metralindole (Inkazan), Moclobemide (Aurorix, Manerix), Pirlindole (Pirazidol), Toloxatone (Humoryl), Agomelatine (Valdoxan), Esketamine (Spravato), Ketamine (Ketalar), Tandospirone (Sediel), Tianeptine (Stabion, Coaxil), Amisulpride (Solian), Aripiprazole (Ability), Brexpiprazole (Rexulti), Lurasidone (Latuda), Olanzapine (Zyprexa), Quetiapine (Seroquel), Risperidone (Risperdal), Trifluoperazine (Stelazine), Buspirone (Buspar), Lithium (Eskalith, Lithobid), Modafinil (Provigil), Thyroxine (T4) and / or Triiodothyronine (T3).

[0128] In an embodiment, the one or more further active agents are one or more SSRIs. In an embodiment, the one or more further active agents are selected from: citalopram, escitalopram, sertraline, fluoxetine, paroxetine or vilazodone. In an embodiment, the one or more further active agents is 10, 20, 30 or 40 mg once daily of citalopram. In an embodiment, the one or more further active agents is 10 or 20 mg once daily of escitalopram. In an embodiment, the one or more further active agents is 50, 100, 150 or 200 mg once daily of sertraline. In an embodiment, the one or more further active agents is 10, 20, 30, 40, 50 or 60 mg once daily of fluoxetine. In an embodiment, the one or more further active agents is 10, 20, 30 or 40 mg once daily of paroxetine. In an embodiment, the one or more further active agents is 10, 20, 30 or 40 mg once daily of vilazodone.

[0129] In an embodiment, the method of treatment comprises the provision of psychological support to the patient. In an embodiment, the method of treatment comprises the provision of psychological support to the patient prior to administration of the pharmaceutical composition. In an embodiment, the method of treatment comprises the provision of psychological support to the patient following administration of the pharmaceutical composition.

[0130] In an embodiment, the method of treatment is a method of treatment of a patient who is diagnosed with major depressive disorder, or moderate to severe major depressive disorder (MDD), by a licensed professional in accordance with accepted medical practice.

[0131] In an embodiment, there is provided a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: psilocin, or a pharmaceutical acceptable salt thereof, and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

[0132] In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin, or a pharmaceutical acceptable salt thereof.

[0133] In an embodiment, there is provided a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin tartrate and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

[0134] In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin tartrate. In an embodiment, there is provided a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin benzoate and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

[0135] In an embodiment, the pharmaceutical composition comprises about 25% w / w psilocin benzoate.

[0136] In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition. In an embodiment, the pharmaceutical composition is a dry powder dry blended pharmaceutical composition. In an embodiment, the pharmaceutical composition is a dry powder spray dried pharmaceutical composition. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition comprising particles larger than 10 microns. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition substantially free of respirable fines. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are larger than 10 microns. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm. In an embodiment, the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80-120pm, and / or d90=130-300pm.

[0137] In an embodiment, there is provided a method wherein 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 91 % or more, 92% or more, 93% or more, 94% or more, 95% or more, 96% or more, 97% or more, 98% or more or 99% or more of the pharmaceutical composition reaches the turbinates and olfactory region of the nasal cavity.

[0138] In an embodiment, the pharmaceutical composition is administered via a nasal delivery device. In an embodiment, the nasal delivery device is a single use device. In an embodiment, the nasal delivery device is passive. In an embodiment, the nasal delivery device is active. In an embodiment, the nasal delivery device is an active nasal delivery device wherein a plunger style actuator, or similar, is depressed to administer a dose. In an embodiment, the nasal delivery device is not a breath actuated delivery device.

[0139] In an embodiment, there is provided a pharmaceutical composition, as described herein, as a composition of matter. In an embodiment, there is provided a kit comprising a pharmaceutical composition, as described herein, and instructions for use. In a related embodiment, the pharmaceutical composition for use is for use in a method of treating a disease or condition in a subject in need thereof, the method including administering to the subject a psilocin salt of the invention in an amount sufficient to treat the disease or condition. The disease or condition can be a neurological injury, neurodegenerative disease, an inflammatory condition, chronic pain, or a psychological condition. In certain embodiments, the disease or condition is an inflammatory condition (e.g., lung inflammation, neuroinflammation, rheumatoid arthritis, atherosclerosis, psoriasis, type II diabetes, inflammatory bowel disease, Crohn’s disease, multiple sclerosis, and / or septicemia). In particular embodiments, the inflammatory condition is chronic obstructive pulmonary disease (COPD), or Alzheimer’s disease. In certain embodiments, the disease or condition is a neurological injury (e.g., a stroke, a traumatic brain injury, or a spinal cord injury). In some embodiments, the disease or condition is chronic pain (e.g., pain resulting from post-operative pain, tension headaches, chronic lower back pain, fibromyalgia, nephropathy, multiple sclerosis, shingles, complex regional pain syndrome, cephalic pain, or sciatica). In particular embodiments, the chronic pain condition results from trigeminal autonomic cephalalgia (e.g., episodic and chronic cluster headache (CH), episodic and chronic paroxysmal hemicrania (PH), and shortlasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT)). In some embodiments, the trigeminal autonomic cephalalgia is episodic or chronic CH. In certain embodiments, the condition is a psychological condition (e.g., depression, anxiety, addiction, post-traumatic stress disorder, an eating disorder, or compulsive behavior). In particular embodiments, the psychological condition is depression or anxiety.

[0140] In some embodiments, the disease or condition is a neurological injury, a neurodegenerative disease, an inflammatory condition, chronic pain, or a psychological condition. In particular embodiments, the disease or condition is an inflammatory condition. In certain embodiments, the inflammatory condition is lung inflammation, neuroinflammation, rheumatoid arthritis, atherosclerosis, psoriasis, type II diabetes, inflammatory bowel disease, Crohn’s disease, multiple sclerosis, and / or septicemia. In some embodiments, the inflammatory condition is chronic obstructive pulmonary disease (COPD), or Alzheimer’s disease. In certain embodiments, the disease or condition is a neurological injury. In particular embodiments, the neurological injury is a stroke, a traumatic brain injury, or a spinal cord injury.

[0141] In some embodiments, the disease or condition is chronic pain. The chronic pain may result from post-operative pain, tension headaches, chronic lower back pain, fibromyalgia, nephropathy, multiple sclerosis, shingles, complex regional pain syndrome, cephalic pain, or sciatica. In particular embodiments, the chronic pain condition results from trigeminal autonomic cephalalgia. The trigeminal autonomic cephalalgia may be selected from the group consisting of episodic and chronic cluster headache (CH), episodic and chronic paroxysmal hemicrania (PH), and short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT). In particular embodiments, the trigeminal autonomic cephalalgia is episodic or chronic CH.

[0142] In some embodiments, the condition is a psychological condition. The psychological condition may be depression, anxiety, addiction, post-traumatic stress disorder, an eating disorder, or compulsive behavior. For example, the psychological condition may be depression. In particular embodiments, the psychological condition is anxiety.

[0143] In certain embodiments the disease or condition is a neurodegenerative disease selected from Alzheimer’s disease, Huntington’s disease, and Parkinson’s disease.

[0144] In certain embodiments, the method includes further administering to the patient a pharmacologically effective amount of an antiemetic agent. The antiemetic agent may include a non- selective 5-HT antagonist, 5-HT3 receptor antagonist, 5-HT4 receptor agonist, CB1 agonist, D2 receptor antagonist, D3 receptor antagonist, GABA receptor agonist, H1 receptor antagonist, muscarinic acetylcholine receptor antagonist, NK1 receptor antagonist, or a combination thereof. In particular embodiments, the antiemetic ondansetron is intravenously infused.

[0145] In some embodiments, the intranasal pharmaceutical composition including a pharmacologically effective amount of psilocin, or a pharmacologically acceptable salt thereof, is administered at least twice over the course of a month (e.g., at least two times, three times, four times, five times, six times, seven times, eight times, nine times, ten times, or more over the course of a month). In some embodiments, the intranasal pharmaceutical composition including a pharmacologically effective amount of psilocin, or a pharmacologically acceptable salt thereof, is administered between 2 and 10 times over the course of a year (e.g., 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, or 10 times over the course of a year).

[0146] In some embodiments, the pharmaceutically acceptable salt thereof of psilocin may be the benzoate, succinate, tartrate, 1 ,5-naphthalenedisulfonate, stearate, lactate, acetate, aspartate, benzenesulfonate, besylate, bicarbonate, bitartrate, bromide, camsylate, carbonate, chloride, citrate, decanoate, edetate, estolate, esylate, fumarate, gluceptate, gluconate, glutamate, glycolate, glycollylarsanilate, hexanoate, hexylresorcinate, hydrabamine, hydroxynaphthoate, iodide, isethionate, lactate, lactobionate, malate, maleate, mandelate, mesylate, methylbromide, methylnitrate, methylsulfate, mucate, napsylate, nitrate, octanoate, oleate, pamoate, pantothenate, phosphate, polygalacturonate, propionate, salicylate, stearate, subacetate, sulfate, teoclate, tosylate, and triethiodide.

[0147] The person skilled in the art will appreciate that embodiments which refer to method of use of a pharmaceutical composition are a disclosure of the pharmaceutical composition per se and said pharmaceutical composition for one or more particular uses.

[0148] Further Embodiments - Aspect A

[0149] Dependencies within the following embodiments 1 to 232 of Aspect A relate to the embodiments of Aspect A.

[0150] 1 . A pharmaceutical composition comprising psilocin benzoate and magnesium stearate. 2. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises from about 0.1% w / w to about 10% w / w magnesium stearate.

[0151] 3. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises from about 0.5% w / w to about 5% w / w magnesium stearate.

[0152] 4. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises about 1% w / w of magnesium stearate.

[0153] 5. The pharmaceutical composition of any one preceding embodiment, wherein the composition is a dry powder composition.

[0154] 6. The pharmaceutical composition of any one preceding embodiment, wherein the composition is a dry blended dry powder composition.

[0155] 7. The pharmaceutical composition of any one preceding embodiment, wherein the composition is a free-flowing pharmaceutical composition.

[0156] 8. The pharmaceutical composition of any one preceding embodiment, wherein the composition is a free-flowing dry powder pharmaceutical composition.

[0157] 9. The pharmaceutical composition of any one preceding embodiment, wherein the composition is a free-flowing dry blended dry powder pharmaceutical composition.

[0158] 10. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s.

[0159] 11. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient has a viscosity of 80-120 mPa«s.

[0160] 12. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient has a viscosity of 100 mPa«s.

[0161] 13. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose.

[0162] 14. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose.

[0163] 15. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose.

[0164] 16. The pharmaceutical composition of any one preceding embodiment, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose.

[0165] 17. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0166] 18. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0167] 19. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0168] 20. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0169] 21. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s.

[0170] 22. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s.

[0171] 23. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises a cellulose-based excipient and wherein the cellulose-based excipient is hydroxypropyl methyl cellulose (HPMC). 24. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 15% to about 60% w / w psilocin benzoate.

[0172] 25. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 20% to about 55% w / w psilocin benzoate.

[0173] 26. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 25% to about 50% w / w psilocin benzoate.

[0174] 27. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 25% w / w psilocin benzoate.

[0175] 28. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 10 mg psilocin freebase equivalent of psilocin benzoate.

[0176] 29. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 8 mg psilocin freebase equivalent of psilocin benzoate.

[0177] 30. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate.

[0178] 31. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate.

[0179] 32. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2 mg to about 4 mg psilocin freebase equivalent of psilocin benzoate.

[0180] 33. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition comprises 25% w / w psilocin benzoate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0181] 34. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition is substantially free of particles smaller than 10 microns, optionally in diameter.

[0182] 35. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition is substantially free of respirable fines.

[0183] 36. The pharmaceutical composition of any one preceding embodiment, wherein 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are larger than 10 microns. 37. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm.

[0184] 38. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80-120pm, and / or d90=130-300pm.

[0185] 39. The pharmaceutical composition of any one preceding embodiment, wherein the pharmaceutical composition is a dry blended dry powder pharmaceutical composition and comprises: magnesium stearate; psilocin benzoate; a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

[0186] 40. A pharmaceutical composition comprising psilocin tartrate and sodium stearyl fumarate.

[0187] 41. The pharmaceutical composition of embodiment 40, wherein the composition comprises from about 0.1 % w / w to about 10% w / w of sodium stearyl fumarate.

[0188] 42. The pharmaceutical composition of embodiment 40 or embodiment 41 , wherein the composition comprises from about 0.1 % w / w to about 5% w / w of sodium stearyl fumarate.

[0189] 43. The pharmaceutical composition of any one of embodiments 40 to 42, wherein the composition comprises from about 0.5% w / w to about 5% w / w of sodium stearyl fumarate.

[0190] 44. The pharmaceutical composition of any one of embodiments 40 to 43, wherein the composition comprises from about 1 % w / w to about 3% w / w of sodium stearyl fumarate.

[0191] 45. The pharmaceutical composition of any one of embodiments 40 to 44, wherein the composition comprises about 1 % w / w of sodium stearyl fumarate.

[0192] 46. The pharmaceutical composition of any one of embodiments 40 to 45, wherein the composition is a dry powder composition. 47. The pharmaceutical composition of any one of embodiments 40 to 46, wherein the composition is a dry blended dry powder composition.

[0193] 48. The pharmaceutical composition of any one of embodiments 40 to 47, wherein the composition is a free-flowing pharmaceutical composition.

[0194] 49. The pharmaceutical composition of any one of embodiments 40 to 48, wherein the composition is a free-flowing dry powder pharmaceutical composition.

[0195] 50. The pharmaceutical composition of any one of embodiments 40 to 49, wherein the composition is a free-flowing dry blended dry powder pharmaceutical composition.

[0196] 51. The pharmaceutical composition of any one of embodiments 40 to 50, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s.

[0197] 52. The pharmaceutical composition of any one of embodiments 40 to 51 , wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient has a viscosity of 80-120 mPa«s.

[0198] 53. The pharmaceutical composition of any one of embodiments 40 to 52, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient has a viscosity of 100 mPa«s.

[0199] 54. The pharmaceutical composition of any one of embodiments 40 to 53, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose.

[0200] 55. The pharmaceutical composition of any one of embodiments 40 to 54, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose.

[0201] 56. The pharmaceutical composition of any one of embodiments 40 to 55, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose.

[0202] 57. The pharmaceutical composition of any one of embodiments 40 to 56, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose- based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose. 58. The pharmaceutical composition of any one of embodiments 40 to 57, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0203] 59. The pharmaceutical composition of any one of embodiments 40 to 58, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0204] 60. The pharmaceutical composition of any one of embodiments 40 to 59, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0205] 61 . The pharmaceutical composition of any one of embodiments 40 to 60, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0206] 62. The pharmaceutical composition of any one of embodiments 40 to 61 , wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s.

[0207] 63. The pharmaceutical composition of any one of embodiments 40 to 62, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s.

[0208] 64. The pharmaceutical composition of any one of embodiments 40 to 63, wherein the pharmaceutical composition comprises a cellulose-based excipient and wherein the cellulose-based excipient is hydroxypropyl methyl cellulose (HPMC).

[0209] 65. The pharmaceutical composition of any one of embodiments 40 to 64, wherein the pharmaceutical composition comprises about 15% to about 60% w / w psilocin tartrate.

[0210] 66. The pharmaceutical composition of any one of embodiments 40 to 65, wherein the pharmaceutical composition comprises about 20% to about 55% w / w psilocin tartrate.

[0211] 67. The pharmaceutical composition of any one of embodiments 40 to 66, wherein the pharmaceutical composition comprises about 25% to about 50% w / w psilocin tartrate.

[0212] 68. The pharmaceutical composition of any one of embodiments 40 to 67, wherein the pharmaceutical composition comprises about 25% w / w psilocin tartrate. 69. The pharmaceutical composition of any one of embodiments 40 to 68, wherein the pharmaceutical composition comprises about 1 mg to about 10 mg psilocin freebase equivalent of psilocin tartrate.

[0213] 70. The pharmaceutical composition of any one of embodiments 40 to 69, wherein the pharmaceutical composition comprises about 1 mg to about 8 mg psilocin freebase equivalent of psilocin tartrate.

[0214] 71 . The pharmaceutical composition of any one of embodiments 40 to 70, wherein the pharmaceutical composition comprises about 1 mg to about 6 mg psilocin freebase equivalent of psilocin tartrate.

[0215] 72. The pharmaceutical composition of any one of embodiments 40 to 71 , wherein the pharmaceutical composition comprises about 2 mg to about 6 mg psilocin freebase equivalent of psilocin tartrate.

[0216] 73. The pharmaceutical composition of any one of embodiments 40 to 72, wherein the pharmaceutical composition comprises about 2 mg to about 4 mg psilocin freebase equivalent of psilocin tartrate.

[0217] 74. The pharmaceutical composition of any one of embodiments 40 to 73, wherein the pharmaceutical composition comprises 25% w / w psilocin tartrate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0218] 75. The pharmaceutical composition of any one of embodiments 40 to 74, wherein the pharmaceutical composition is substantially free of particles smaller than 10 microns, optionally in diameter.

[0219] 76. The pharmaceutical composition of any one of embodiments 40 to 76, wherein the pharmaceutical composition is substantially free of respirable fines.

[0220] 77. The pharmaceutical composition of any one of embodiments 40 to 77, wherein 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are larger than 10 microns.

[0221] 78. The pharmaceutical composition of any one of embodiments 40 to 78, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm.

[0222] 79. The pharmaceutical composition of any one of embodiments 40 to 79, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80-120pm, and / or d90=130-300pm.

[0223] 80. The pharmaceutical composition of any one of embodiments 40 to 79, wherein the pharmaceutical composition is a dry blended dry powder pharmaceutical composition and comprises: sodium stearyl fumarate; psilocin tartrate; a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition is crystalline. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below: The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.5, 10.9±0.5, 12.3±0.5, 13.3±0.5, 14.5±0.5, 15.3±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5, 19.7±0.5, 20.0±0.5, 20.8±0.5, 21.3±0.5, 21.9±0.5, 22.6±0.5, 22.9±0.5, 23.8±0.5, 24.1 ±0.5, 24.9±0.5, 25.6±0.5, 26.0±0.5, 26.3±0.5, 26.5±0.5, 26.9±0.5, 27.5±0.5, and 28.5±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of

[0224] 1.5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.4, 10.9±0.4, 12.3±0.4, 13.3±0.4, 14.5±0.4, 15.3±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4, 19.7±0.4, 20.0±0.4, 20.8±0.4, 21.3±0.4, 21.9±0.4, 22.6±0.4, 22.9±0.4, 23.8±0.4, 24.1 ±0.4, 24.9±0.4, 25.6±0.4, 26.0±0.4, 26.3±0.4, 26.5±0.4, 26.9±0.4, 27.5±0.4, and 28.5±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of

[0225] 1.5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.3, 10.9±0.3, 12.3±0.3, 13.3±0.3, 14.5±0.3, 15.3±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, 19.7±0.3, 20.0±0.3, 20.8±0.3, 21.3±0.3, 21.9±0.3, 22.6±0.3, 22.9±0.3, 23.8±0.3, 24.1 ±0.3, 24.9±0.3, 25.6±0.3, 26.0±0.3, 26.3±0.3, 26.5±0.3, 26.9±0.3, 27.5±0.3, and 28.5±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of

[0226] 1.5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.2, 10.9±0.2, 12.3±0.2, 13.3±0.2, 14.5±0.2, 15.3±0.2, 16.3±0.2, 16.4±0.2, 18.2±0.2, 18.9±0.2, 19.3±0.2, 19.7±0.2, 20.0±0.2, 20.8±0.2, 21.3±0.2, 21.9±0.2, 22.6±0.2, 22.9±0.2, 23.8±0.2, 24.1 ±0.2, 24.9±0.2, 25.6±0.2, 26.0±0.2, 26.3±0.2, 26.5±0.2, 26.9±0.2, 27.5±0.2, and 28.5±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of

[0227] 1.5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.1 , 10.9±0.1 , 12.3±0.1 , 13.3±0.1 , 14.5±0.1 , 15.3±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , 19.7±0.1 , 20.0±0.1 , 20.8±0.1 , 21.3±0.1 , 21.9±0.1 , 22.6±0.1 , 22.9±0.1 , 23.8±0.1 , 24.1 ±0.1 , 24.9±0.1 , 25.6±0.1 , 26.0±0.1 , 26.3±0.1 , 26.5±0.1 , 26.9±0.1 , 27.5±0.1 , and 28.5±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.5, 18.2±0.5, and 18.9±0.5 (BEN Pattern 1) as measured using an x- ray wavelength of 1 .5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 18.2±0.5, 18.9±0.5 and 19.3±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5 and 19.7±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.4, 18.2±0.4, and 18.9±0.4 (BEN Pattern 1) as measured using an x- ray wavelength of 1 .5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 18.2±0.4, 18.9±0.4 and 19.3±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4 and 19.7±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.3, 18.2±0.3, and 18.9±0.3 (BEN Pattern 1) as measured using an x- ray wavelength of 1 .5406 A. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 18.2±0.3, 18.9±0.3, and 19.3±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. 97. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, and 19.7±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0228] 98. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.2, 18.2±0.2, and 18.9±0.2 (BEN Pattern 1) as measured using an x- ray wavelength of 1 .5406 A.

[0229] 99. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.2, 16.3±0.2, 18.2±0.2, 18.9±0.2, and 19.3±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0230] 100. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A.

[0231] 101. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.1 , 18.2±0.1 , and 18.9±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0232] 102. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 18.2±0.1 , 18.9±0.1 and 19.3±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A.

[0233] 103. The pharmaceutical composition of any one of embodiments 1 to 39, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A.

[0234] 104. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition is crystalline.

[0235] 105. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below: . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.5, 12.6±0.5, 13.4±0.5, 14.7±0.5, 15.8±0.5, 16.2±0.5, 17.2±0.5, 18.8±0.5, 19.9±0.5, 20.8±0.5, 21.8±0.5, 22.5±0.5, 23.4±0.5, 23.7±0.5, 24.7±0.5, 25.5±0.5, 26.5±0.5, 27.0±0.5, 28.5±0.5, and 29.4±0.5 (TAR Pattern 1) as measured by

[0236] X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.4, 12.6±0.4, 13.4±0.4, 14.7±0.4, 15.8±0.4,

[0237] 16.2±0.4, 17.2±0.4, 18.8±0.4, 19.9±0.4, 20.8±0.4, 21.8±0.4, 22.5±0.4, 23.4±0.4, 23.7±0.4, 24.7±0.4, 25.5±0.4, 26.5±0.4, 27.0±0.4, 28.5±0.4, and 29.4±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. 109. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.3, 12.6±0.3, 13.4±0.3, 14.7±0.3, 15.8±0.3, 16.2±0.3, 17.2±0.3, 18.8±0.3, 19.9±0.3, 20.8±0.3, 21.8±0.3, 22.5±0.3, 23.4±0.3, 23.7±0.3, 24.7±0.3, 25.5±0.3, 26.5±0.3, 27.0±0.3, 28.5±0.3, and 29.4±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0238] 110. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.2, 12.6±0.2, 13.4±0.2, 14.7±0.2, 15.8±0.2, 16.2±0.2, 17.2±0.2, 18.8±0.2, 19.9±0.2, 20.8±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.7±0.2, 24.7±0.2, 25.5±0.2, 26.5±0.2, 27.0±0.2, 28.5±0.2, and 29.4±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0239] 111. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.1 , 12.6±0.1 , 13.4±0.1 , 14.7±0.1 , 15.8±0.1 , 16.2±0.1 , 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 20.8±0.1 , 21.8±0.1 , 22.5±0.1 , 23.4±0.1 , 23.7±0.1 , 24.7±0.1 , 25.5±0.1 , 26.5±0.1 , 27.0±0.1 , 28.5±0.1 , and 29.4±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0240] 112. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0241] 113. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0242] 114. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, 21 ,8±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0243] 115. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, 21 ,8±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, 21 ,8±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, 21 ,8±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0244] 125. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0245] 126. The pharmaceutical composition of any one of embodiments 40 to 80, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 21 ,8±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0246] 127. A pharmaceutical composition comprising psilocin, or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose.

[0247] 128. The pharmaceutical composition of embodiment 127, wherein the pharmaceutical composition comprises crystalline psilocin, or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose.

[0248] 129. The pharmaceutical composition of any one of embodiments 127 to 128, wherein the pharmaceutical composition comprises about 0.1 % w / w to about 10% w / w microcrystalline cellulose.

[0249] 130. The pharmaceutical composition of any one of embodiments 127 to 129, wherein the pharmaceutical composition comprises about 0.5% w / w to about 9% w / w microcrystalline cellulose.

[0250] 131. The pharmaceutical composition of any one of embodiments 127 to 130, wherein the pharmaceutical composition comprises about 1 % w / w to about 8% w / w microcrystalline cellulose.

[0251] 132. The pharmaceutical composition of any one of embodiments 127 to 131 , wherein the pharmaceutical composition comprises about 2% w / w to about 7% w / w microcrystalline cellulose.

[0252] 133. The pharmaceutical composition of any one of embodiments 127 to 132, wherein the pharmaceutical composition comprises about 3% w / w to about 6% w / w microcrystalline cellulose.

[0253] 134. The pharmaceutical composition of any one of embodiments 127 to 133, wherein the pharmaceutical composition comprises about 4% w / w to about 5% w / w microcrystalline cellulose.

[0254] 135. The pharmaceutical composition of any one of embodiments 127 to 134, wherein the pharmaceutical composition comprises about 5% w / w microcrystalline cellulose. . The pharmaceutical composition of any one of embodiments 127 to 135, wherein the composition is a dry powder composition. . The pharmaceutical composition of any one of embodiments 127 to 136, wherein the composition is a dry blended dry powder composition. . The pharmaceutical composition of any one of embodiments 127 to 137, wherein the composition is a free-flowing pharmaceutical composition. . The pharmaceutical composition of any one of embodiments 127 to 138, wherein the composition is a free-flowing dry powder pharmaceutical composition. . The pharmaceutical composition of any one of embodiments 127 to 139, wherein the composition is a free-flowing dry blended dry powder pharmaceutical composition. . The pharmaceutical composition of any one of embodiments 127 to 140, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s. . The pharmaceutical composition of any one of embodiments 127 to 141 , wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient has a viscosity of 80-120 mPa«s. . The pharmaceutical composition of any one of embodiments 127 to 142, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient has a viscosity of 100 mPa«s. . The pharmaceutical composition of any one of embodiments 127 to 143, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose. . The pharmaceutical composition of any one of embodiments 127 to 144, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose. . The pharmaceutical composition of any one of embodiments 127 to 145, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose. . The pharmaceutical composition of any one of embodiments 127 to 146, wherein the composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose.

[0255] 148. The pharmaceutical composition of any one of embodiments 127 to 147, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0256] 149. The pharmaceutical composition of any one of embodiments 127 to 148, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30,

[0257] 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0258] 150. The pharmaceutical composition of any one of embodiments 127 to 149, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0259] 151. The pharmaceutical composition of any one of embodiments 127 to 150, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30,

[0260] 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0261] 152. The pharmaceutical composition of any one of embodiments 127 to 151 , wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s.

[0262] 153. The pharmaceutical composition of any one of embodiments 127 to 152, wherein the pharmaceutical composition comprises about 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30,

[0263] 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60 or about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s.

[0264] 154. The pharmaceutical composition of any one of embodiments 127 to 153, wherein the pharmaceutical composition comprises a cellulose-based excipient and wherein the cellulose- based excipient is hydroxypropyl methyl cellulose (HPMC).

[0265] 155. The pharmaceutical composition of any one of embodiments 127 to 154, wherein the pharmaceutical composition comprises about 15% to about 60% w / w psilocin benzoate or psilocin tartrate.

[0266] 156. The pharmaceutical composition of any one of embodiments 127 to 155, wherein the pharmaceutical composition comprises about 20% to about 55% w / w psilocin benzoate or psilocin tartrate. 157. The pharmaceutical composition of any one of embodiments 127 to 156, wherein the pharmaceutical composition comprises about 25% to about 50% w / w psilocin benzoate or psilocin tartrate.

[0267] 158. The pharmaceutical composition of any one of embodiments 127 to 157, wherein the pharmaceutical composition comprises about 25% w / w psilocin benzoate or psilocin tartrate.

[0268] 159. The pharmaceutical composition of any one of embodiments 127 to 158, wherein the pharmaceutical composition comprises about 1 mg to about 10 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate.

[0269] 160. The pharmaceutical composition of any one of embodiments 127 to 159, wherein the pharmaceutical composition comprises about 1 mg to about 8 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate.

[0270] 161. The pharmaceutical composition of any one of embodiments 127 to 160, wherein the pharmaceutical composition comprises about 1 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate.

[0271] 162. The pharmaceutical composition of any one of embodiments 127 to 161 , wherein the pharmaceutical composition comprises about 2 mg to about 6 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate.

[0272] 163. The pharmaceutical composition of any one of embodiments 127 to 162, wherein the pharmaceutical composition comprises about 2 mg to about 4 mg psilocin freebase equivalent of psilocin benzoate or psilocin tartrate.

[0273] 164. The pharmaceutical composition of any one of embodiments 127 to 163, wherein the pharmaceutical composition comprises 25% w / w psilocin benzoate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0274] 165. The pharmaceutical composition of any one of embodiments 127 to 164, wherein the pharmaceutical composition is substantially free of particles smaller than 10 microns, optionally in diameter.

[0275] 166. The pharmaceutical composition of any one of embodiments 127 to 165, wherein the pharmaceutical composition is substantially free of respirable fines.

[0276] 167. The pharmaceutical composition of any one of embodiments 127 to 166, wherein 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are larger than 10 microns. . The pharmaceutical composition of any one of embodiments 127 to 167, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm. . The pharmaceutical composition of any one of embodiments 127 to 168, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80- 120pm, and / or d90=130-300pm. . The pharmaceutical composition of any one of embodiments 127 to 169, wherein the pharmaceutical composition is a dry blended dry powder pharmaceutical composition and comprises: microcrystalline cellulose; psilocin benzoate or psilocin tartrate; a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below: . The pharmaceutical composition of any one of embodiments 127 to 171 , wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.5, 10.9±0.5, 12.3±0.5, 13.3±0.5, 14.5±0.5, 15.3±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5, 19.7±0.5, 20.0±0.5, 20.8±0.5, 21.3±0.5,

[0277] 21.9±0.5, 22.6±0.5, 22.9±0.5, 23.8±0.5, 24.1 ±0.5, 24.9±0.5, 25.6±0.5, 26.0±0.5, 26.3±0.5,

[0278] 26.5±0.5, 26.9±0.5, 27.5±0.5, and 28.5±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 172, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.4, 10.9±0.4, 12.3±0.4, 13.3±0.4, 14.5±0.4, 15.3±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4, 19.7±0.4, 20.0±0.4, 20.8±0.4, 21.3±0.4,

[0279] 21.9±0.4, 22.6±0.4, 22.9±0.4, 23.8±0.4, 24.1 ±0.4, 24.9±0.4, 25.6±0.4, 26.0±0.4, 26.3±0.4,

[0280] 26.5±0.4, 26.9±0.4, 27.5±0.4, and 28.5±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 173, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.3, 10.9±0.3, 12.3±0.3, 13.3±0.3, 14.5±0.3, 15.3±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, 19.7±0.3, 20.0±0.3, 20.8±0.3, 21.3±0.3,

[0281] 21.9±0.3, 22.6±0.3, 22.9±0.3, 23.8±0.3, 24.1 ±0.3, 24.9±0.3, 25.6±0.3, 26.0±0.3, 26.3±0.3,

[0282] 26.5±0.3, 26.9±0.3, 27.5±0.3, and 28.5±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 174, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.2, 10.9±0.2, 12.3±0.2, 13.3±0.2, 14.5±0.2, 15.3±0.2, 16.3±0.2, 16.4±0.2, 18.2±0.2, 18.9±0.2, 19.3±0.2, 19.7±0.2, 20.0±0.2, 20.8±0.2, 21.3±0.2, 21.9±0.2, 22.6±0.2, 22.9±0.2, 23.8±0.2, 24.1 ±0.2, 24.9±0.2, 25.6±0.2, 26.0±0.2, 26.3±0.2, 26.5±0.2, 26.9±0.2, 27.5±0.2, and 28.5±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 175, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 9.4±0.1 , 10.9±0.1 , 12.3±0.1 , 13.3±0.1 , 14.5±0.1 , 15.3±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , 19.7±0.1 , 20.0±0.1 , 20.8±0.1 , 21.3±0.1 ,

[0283] 21.9±0.1 , 22.6±0.1 , 22.9±0.1 , 23.8±0.1 , 24.1±0.1 , 24.9±0.1 , 25.6±0.1 , 26.0±0.1 , 26.3±0.1 ,

[0284] 26.5±0.1 , 26.9±0.1 , 27.5±0.1 , and 28.5±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 176, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.5, 18.2±0.5, and 18.9±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 177, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 18.2±0.5, 18.9±0.5 and 19.3±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 178, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.5, 16.3±0.5, 16.4±0.5, 18.2±0.5, 18.9±0.5, 19.3±0.5 and 19.7±0.5 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. . The pharmaceutical composition of any one of embodiments 127 to 179, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.4, 18.2±0.4, and 18.9±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 180, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 18.2±0.4, 18.9±0.4 and 19.3±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 181 , wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.4, 16.3±0.4, 16.4±0.4, 18.2±0.4, 18.9±0.4, 19.3±0.4 and 19.7±0.4 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. . The pharmaceutical composition of any one of embodiments 127 to 182, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.3, 18.2±0.3, and 18.9±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 183, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 18.2±0.3, 18.9±0.3, and 19.3±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 184, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.3, 16.3±0.3, 16.4±0.3, 18.2±0.3, 18.9±0.3, 19.3±0.3, and 19.7±0.3 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. . The pharmaceutical composition of any one of embodiments 127 to 185, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.2, 18.2±0.2, and 18.9±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 186, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.2, 16.3±0.2, 18.2±0.2, 18.9±0.2, and 19.3±0.2 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 187, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 , and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1.5406 A. . The pharmaceutical composition of any one of embodiments 127 to 188, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 16.3±0.1 , 18.2±0.1 , and 18.9±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 189, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 18.2±0.1 , 18.9±0.1 and 19.3±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 190, wherein the pharmaceutical composition comprises crystalline psilocin benzoate as characterized by one or more peaks at diffraction angle 20(°) 14.5±0.1 , 16.3±0.1 , 16.4±0.1 , 18.2±0.1 , 18.9±0.1 , 19.3±0.1 and 19.7±0.1 (BEN Pattern 1) as measured using an x-ray wavelength of 1 .5406 A. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks, as measured using a wavelength of 1 .5406 A, from the Table below: . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.5, 12.6±0.5, 13.4±0.5, 14.7±0.5, 15.8±0.5, 16.2±0.5, 17.2±0.5, 18.8±0.5, 19.9±0.5, 20.8±0.5, 21.8±0.5, 22.5±0.5, 23.4±0.5, 23.7±0.5, 24.7±0.5, 25.5±0.5, 26.5±0.5, 27.0±0.5, 28.5±0.5, and 29.4±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.4, 12.6±0.4, 13.4±0.4, 14.7±0.4, 15.8±0.4, 16.2±0.4, 17.2±0.4, 18.8±0.4, 19.9±0.4, 20.8±0.4, 21.8±0.4, 22.5±0.4, 23.4±0.4, 23.7±0.4, 24.7±0.4, 25.5±0.4, 26.5±0.4, 27.0±0.4, 28.5±0.4, and 29.4±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0285] 195. The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.3, 12.6±0.3, 13.4±0.3, 14.7±0.3, 15.8±0.3, 16.2±0.3, 17.2±0.3, 18.8±0.3, 19.9±0.3, 20.8±0.3, 21.8±0.3, 22.5±0.3, 23.4±0.3, 23.7±0.3, 24.7±0.3, 25.5±0.3, 26.5±0.3, 27.0±0.3, 28.5±0.3, and 29.4±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0286] 196. The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.2, 12.6±0.2, 13.4±0.2, 14.7±0.2, 15.8±0.2, 16.2±0.2, 17.2±0.2, 18.8±0.2, 19.9±0.2, 20.8±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.7±0.2, 24.7±0.2, 25.5±0.2, 26.5±0.2, 27.0±0.2, 28.5±0.2, and 29.4±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0287] 197. The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 6.7±0.1 , 12.6±0.1 , 13.4±0.1 , 14.7±0.1 , 15.8±0.1 , 16.2±0.1 , 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 20.8±0.1 , 21.8±0.1 , 22.5±0.1 , 23.4±0.1 , 23.7±0.1 , 24.7±0.1 , 25.5±0.1 , 26.5±0.1 , 27.0±0.1 , 28.5±0.1 , and 29.4±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0288] 198. The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0289] 199. The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0290] 200. The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.5, 18.8±0.5, 19.9±0.5, 21 ,8±0.5, and 22.5±0.5 (TAR Pattern 1) as measured by X-ray powder diffractometry.

[0291] 201. The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.4, 18.8±0.4, 19.9±0.4, 21 ,8±0.4, and 22.5±0.4 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.3, 18.8±0.3, 19.9±0.3, 21 ,8±0.3, and 22.5±0.3 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.2, 18.8±0.2, 19.9±0.2, 21 ,8±0.2, and 22.5±0.2 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one of embodiments 127 to 170, wherein the pharmaceutical composition comprises crystalline psilocin tartrate as characterized by one or more peaks at diffraction angle 20 (°) selected from 17.2±0.1 , 18.8±0.1 , 19.9±0.1 , 21 ,8±0.1 , and 22.5±0.1 (TAR Pattern 1) as measured by X-ray powder diffractometry. . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment. . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the composition is administered:

[0292] Intransally;

[0293] Via inhalation;

[0294] Intravenously;

[0295] Intramuscularly; or Subcutaneously. . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the disease or condition is selected from one or more of: major depressive disorder (MDD), moderate to severe MDD, treatment-resistant MDD, major depression, melancholic depression, atypical depression, dysthymia, anxiety, treatment-resistant anxiety, end of life anxiety, generalised anxiety disorder, panic disorder, social anxiety, post-traumatic stress disorder, acute stress disorder, obsessive compulsive disorder, social phobia, substance abuse, alcoholism, tobacco abuse, drug abuse, anorexia nervosa, bulimia nervosa, binge eating disorder, primary impulse-control disorders, and obsessive-compulsive disorder. . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method comprises the administration of the pharmaceutical composition without concomitant treatment with one or more further active agents, optionally without concomitant treatment with one or more further active agents selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound; optionally wherein the subject discontinues treatment with the one or more further active agents prior to undergoing treatment with the pharmaceutical composition. . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents. . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound. . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex), Fluoxetine (Prozac, Sarafem), Fluvoxamine (Luvox, Faverin), Paroxetine (Paxil, Seroxat), Sertraline (Zoloft, Lustral), Desven I afaxine (Pristiq), Duloxetine (Cymbalta), Levomilnacipran (Fetzima), Milnacipran (Ixel, Savella), Venlafaxine (Effexor), Vilazodone (Viibryd), Vortioxetine (Trintellix), Nefazodone (Dutonin, Nefadar, Serzone), Trazodone (Desyrel), Reboxetine (Edronax), Teniloxazine (Lucelan, Metatone), Viloxazine (Vivalan), Bupropion (Wellbutrin), Amitriptyline (Elavil, Endep), Amitriptylinoxide (Amioxid, Ambivalon, Equilibria), Clomipramine (Anafranil), Desipramine (Norpramin, Pertofrane), Dibenzepin (Noveril, Victoril), Dimetacrine (Istonil), Dosulepin (Prothiaden), Doxepin (Adapin, Sinequan), Imipramine (Tofranil), Lofepramine (Lomont, Gamanil), Melitracen (Dixeran, Melixeran, Trausabun), Nitroxazepine (Sintamil), Nortriptyline (Pamelor, Aventyl), Noxiptiline (Agedal, Elronon, Nogedal), Opipramol (Insidon), Pipofezine (Azafen / Azaphen), Protriptyline (Vivactil), Trimipramine (Surmontil), Amoxapine (Asendin), Maprotiline (Ludiomil), Mianserin (Tolvon), Mirtazapine (Remeron), Setiptiline (Tecipul), Isocarboxazid (Marplan), Phenelzine (Nardil), Tranylcypromine (Parnate), Selegiline (Eldepryl, Zelapar, Emsam), Caroxazone (Surodil, Timostenil), Metralindole (Inkazan), Moclobemide (Aurorix, Manerix), Pirlindole (Pirazidol), Toloxatone (Humoryl), Agomelatine (Valdoxan), Esketamine (Spravato), Ketamine (Ketalar), Tandospirone (Sediel), Tianeptine (Stabion, Coaxil), Amisulpride (Solian), Aripiprazole (Ability), Brexpiprazole (Rexulti), Lurasidone (Latuda), Olanzapine (Zyprexa), Quetiapine (Seroquel), Risperidone (Risperdal), Trifluoperazine (Stelazine), Buspirone (Buspar), Lithium (Eskalith, Lithobid), Modafinil (Provigil), Thyroxine (T4) and / or Triiodothyronine (T3).

[0296] 220. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are one or more SSRIs.

[0297] 221 . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: citalopram, escitalopram, sertraline, fluoxetine, paroxetine or vilazodone.

[0298] 222. The pharmaceutical composition for use of embodiment 221 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of citalopram.

[0299] 223. The pharmaceutical composition for use of embodiment 221 , wherein the one or more further active agents is 10 or 20 mg once daily of escitalopram.

[0300] 224. The pharmaceutical composition for use of embodiment 221 , wherein the one or more further active agents is 50, 100, 150 or 200 mg once daily of sertraline.

[0301] 225. The pharmaceutical composition for use of embodiment 221 , wherein the one or more further active agents is 10, 20, 30, 40, 50 or 60 mg once daily of fluoxetine.

[0302] 226. The pharmaceutical composition for use of embodiment 221 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of paroxetine.

[0303] 227. The pharmaceutical composition for use of embodiment 221 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of vilazodone.

[0304] 228. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method of treatment comprises the provision of psychological support to the patient. 229. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method of treatment comprises the provision of psychological support to the patient prior to administration of the pharmaceutical composition.

[0305] 230. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method of treatment comprises the provision of psychological support to the patient following administration of the pharmaceutical composition.

[0306] 231 . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method of treatment is a method of treatment of moderate to severe major depressive disorder (MDD).

[0307] 232. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding embodiment, wherein the method of treatment is a method of treatment of a patient who is diagnosed with major depressive disorder, or moderate to severe major depressive disorder (MDD), by a licensed professional in accordance with accepted medical practice.

[0308] Further Embodiments - Aspect B

[0309] Dependencies within the following embodiments 1 to 57 of Aspect B relate to the embodiments of Aspect B.

[0310] 1. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin, or a pharmaceutical acceptable salt thereof, and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s.

[0311] 2. The method of embodiment 1 , wherein the cellulose-based excipient has a viscosity of 80-120 mPa«s. 3. The method of any one preceding embodiment, wherein the cellulose-based excipient has a viscosity of 100 mPa«s.

[0312] 4. The method of any one preceding embodiment, wherein the cellulose-based excipient is methylcellulose.

[0313] 5. The method of any one preceding embodiment, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 7.5% to about 17.5% w / w methylcellulose.

[0314] 6. The method of any one preceding embodiment, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 10% to about 15% w / w methylcellulose.

[0315] 7. The method of any one preceding embodiment, wherein the cellulose-based excipient is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose.

[0316] 8. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0317] 9. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 62.5% w / w of a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s.

[0318] 10. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0319] 11. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 62.5% w / w of a cellulose-based excipient having a viscosity of 2-10, 3-9, 4-8, 6 or 7 mPa«s.

[0320] 12. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 6 mPa«s.

[0321] 13. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 62.5% w / w of a cellulose-based excipient having a viscosity of 6 mPa«s.

[0322] 14. The method of any one of embodiments 8 to 13, wherein the cellulose-based excipient is hydroxypropyl methyl cellulose (HPMC). 15. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 15% to about 60% w / w psilocin or a pharmaceutically acceptable salt thereof.

[0323] 16. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 20% to about 55% w / w psilocin or a pharmaceutically acceptable salt thereof.

[0324] 17. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 25% to about 50% w / w psilocin or a pharmaceutically acceptable salt thereof.

[0325] 18. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 25% w / w psilocin or a pharmaceutically acceptable salt thereof.

[0326] 19. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 10 mg of psilocin freebase or about 1 mg to about 10 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0327] 20. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 8 mg of psilocin freebase or about 1 mg to about 8 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0328] 21. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 6 mg of psilocin freebase or about 1 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0329] 22. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2 mg to about 6 mg of psilocin freebase or about 2 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0330] 23. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2 mg to about 4 mg of psilocin freebase or about 2 mg to about 4 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0331] 24. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises psilocin benzoate.

[0332] 25. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises 25% w / w psilocin benzoate, 12.5% w / w methylcellulose and 62.5% HPMC.

[0333] 26. The method of any one of embodiments 1 to 23, wherein the pharmaceutical composition comprises psilocin tartrate. The method of any one of embodiments 1 to 23, wherein the pharmaceutical composition comprises 25% w / w psilocin tartrate, 12.5% w / w methylcellulose and 62.5% HPMC. The method of any one preceding embodiment, wherein the disease or condition is selected from one or more of: major depressive disorder (MDD), moderate to severe MDD, treatment-resistant MDD, major depression, melancholic depression, atypical depression, dysthymia, anxiety, treatment-resistant anxiety, end of life anxiety, generalised anxiety disorder, panic disorder, social anxiety, post-traumatic stress disorder, acute stress disorder, obsessive compulsive disorder, social phobia, substance abuse, alcoholism, tobacco abuse, drug abuse, anorexia nervosa, bulimia nervosa, binge eating disorder, primary impulse-control disorders, and obsessive- compulsive disorder. The method of any one preceding embodiment, wherein the method comprises the administration of the pharmaceutical composition without concomitant treatment with one or more further active agents, optionally without concomitant treatment with one or more further active agents selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound; optionally wherein the subject discontinues treatment with the one or more further active agents prior to undergoing treatment with the pharmaceutical composition. The method of any one of embodiments 1-28, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents. The method of embodiment 30, wherein the one or more further active agents are selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound. The method of embodiment 31 , wherein the one or more further active agents are selected from: Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex), Fluoxetine (Prozac, Sarafem), Fluvoxamine (Luvox, Faverin), Paroxetine (Paxil, Seroxat), Sertraline (Zoloft, Lustral), Desvenlafaxine (Pristiq), Duloxetine (Cymbalta), Levomilnacipran (Fetzima), Milnacipran (Ixel, Savella), Venlafaxine (Effexor), Vilazodone (Viibryd), Vortioxetine (Trintellix), Nefazodone (Dutonin, Nefadar, Serzone), Trazodone (Desyrel), Reboxetine (Edronax), Teniloxazine (Lucelan, Metatone), Viloxazine (Vivalan), Bupropion (Wellbutrin), Amitriptyline (Elavil, Endep), Amitriptylinoxide (Amioxid, Ambivalon, Equilibria), Clomipramine (Anafranil), Desipramine (Norpramin, Pertofrane), Dibenzepin (Noveril, Victoril), Dimetacrine (Istonil), Dosulepin (Prothiaden), Doxepin (Adapin, Sinequan), Imipramine (Tofranil), Lofepramine (Lomont, Gamanil), Melitracen (Dixeran, Melixeran, Trausabun), Nitroxazepine (Sintamil), Nortriptyline (Pamelor, Aventyl), Noxiptiline (Agedal, Elronon, Nogedal), Opipramol (Insidon), Pipofezine (Azafen / Azaphen), Protriptyline (Vivactil), Trimipramine (Surmontil), Amoxapine (Asendin), Maprotiline (Ludiomil), Mianserin (Tolvon), Mirtazapine (Remeron), Setiptiline (Tecipul), Isocarboxazid (Marplan), Phenelzine (Nardil), Tranylcypromine (Parnate), Selegiline (Eldepryl, Zelapar, Emsam), Caroxazone (Surodil, Timostenil), Metralindole (Inkazan), Moclobemide (Aurorix, Manerix), Pirlindole (Pirazidol), Toloxatone (Humoryl), Agomelatine (Valdoxan), Esketamine (Spravato), Ketamine (Ketalar), Tandospirone (Sediel), Tianeptine (Stabion, Coaxil), Amisulpride (Solian), Aripiprazole (Ability), Brexpiprazole (Rexulti), Lurasidone (Latuda), Olanzapine (Zyprexa), Quetiapine (Seroquel), Risperidone (Risperdal), Trifluoperazine (Stelazine), Buspirone (Buspar), Lithium (Eskalith, Lithobid), Modafinil (Provigil), Thyroxine (T4) and / or Triiodothyronine (T3).

[0334] 33. The method of embodiment 31 , wherein the one or more further active agents are one or more SSRIs.

[0335] 34. The method of embodiment 33, wherein the one or more further active agents are selected from: citalopram, escitalopram, sertraline, fluoxetine, paroxetine or vilazodone.

[0336] 35. The method of embodiment 34, wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of citalopram.

[0337] 36. The method of embodiment 34, wherein the one or more further active agents is 10 or 20 mg once daily of escitalopram.

[0338] 37. The method of embodiment 34, wherein the one or more further active agents is 50, 100, 150 or 200 mg once daily of sertraline.

[0339] 38. The method of embodiment 34, wherein the one or more further active agents is 10, 20, 30, 40, 50 or 60 mg once daily of fluoxetine.

[0340] 39. The method of embodiment 34, wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of paroxetine.

[0341] 40. The method of embodiment 34, wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of vilazodone.

[0342] 41. The method of any one preceding embodiment, wherein the method of treatment comprises the provision of psychological support to the patient.

[0343] 42. The method of any one preceding embodiment, wherein the method of treatment comprises the provision of psychological support to the patient prior to administration of the pharmaceutical composition.

[0344] 43. The method of any one preceding embodiment, wherein the method of treatment comprises the provision of psychological support to the patient following administration of the pharmaceutical composition. The method of any one preceding embodiment, wherein the method of treatment is a method of treatment of a patient who is diagnosed with major depressive disorder, or moderate to severe major depressive disorder (MDD), by a licensed professional in accordance with accepted medical practice. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: psilocin, or a pharmaceutical acceptable salt thereof, and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC. The method of embodiment 45, wherein the pharmaceutical composition comprises about 25% w / w psilocin, or a pharmaceutical acceptable salt thereof. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin tartrate and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC. The method of embodiment 47, wherein the pharmaceutical composition comprises about 25% w / w psilocin tartrate. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin benzoate and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

[0345] 50. The method of embodiment 49, wherein the pharmaceutical composition comprises about 25% w / w psilocin benzoate.

[0346] 51. The method of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition.

[0347] 52. The method of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder spray dried pharmaceutical composition.

[0348] 53. The method of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition comprising particles larger than 10 microns.

[0349] 54. The method of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition substantially free of respirable fines.

[0350] 55. The method of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein 75, 80, 90, 95, 98, 99, 99.5, 99.8 or 99.9% of the particles of the pharmaceutical composition are larger than 10 microns.

[0351] 56. The method of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition comprises particles having a median diameter of less than 2000pm, 1000pm, 500pm, 250pm, 100pm, 50pm, or 1 pm.

[0352] 57. The method of any one preceding embodiment, wherein the pharmaceutical composition is a dry powder pharmaceutical composition and wherein the pharmaceutical composition has a particle size distribution of d10=20-60pm, and / or d50=80-120pm, and / or d90=130-300pm.

[0353] Further Embodiments - Aspect C

[0354] Dependencies within the following embodiments 1 to 45 of Aspect C relate to the embodiments of Aspect C.

[0355] 1 . A pharmaceutical composition comprising a pharmaceutically acceptable salt of psilocin and one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is a dry blended dry powder composition. 2. The pharmaceutical composition according to embodiment 1 , wherein the psilocin salt is psilocin benzoate.

[0356] 3. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin benzoate.

[0357] 4. The pharmaceutical composition according to embodiment 1 , wherein the psilocin salt is psilocin tartrate.

[0358] 5. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin tartrate.

[0359] 6. The pharmaceutical composition according to any one of embodiments 1 to 5, comprising a cellulose-based excipient.

[0360] 7. The pharmaceutical composition according to embodiment 6, wherein the cellulose-based excipient is methyl cellulose or hydroxypropyl methyl cellulose (HPMC).

[0361] 8. The pharmaceutical composition according to any one of embodiments 1 to 5, comprising methyl cellulose and hydroxypropyl methyl cellulose (HPMC).

[0362] 9. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 10 mg of psilocin freebase or about 1 mg to about 10 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0363] 10. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 8 mg of psilocin freebase or about 1 mg to about 8 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0364] 11. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 1 mg to about 6 mg of psilocin freebase or about 1 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0365] 12. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2 mg to about 6 mg of psilocin freebase or about 2 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0366] 13. The method of any one preceding embodiment, wherein the pharmaceutical composition comprises about 2 mg to about 4 mg of psilocin freebase or about 2 mg to about 4 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

[0367] 14. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin salt. 15. The pharmaceutical composition according to embodiment 1 , comprising 12.5% w / w methyl cellulose.

[0368] 16. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin salt and 12.5% w / w methyl cellulose.

[0369] 17. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin benzoate and 12.5% w / w methyl cellulose.

[0370] 18. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin tartrate and 12.5% w / w methyl cellulose.

[0371] 19. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin salt, 62.5% w / w HPMC and 12.5% w / w methyl cellulose.

[0372] 20. The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin benzoate, 62.5% w / w HPMC and 12.5% w / w methyl cellulose.

[0373] 21 . The pharmaceutical composition according to embodiment 1 , comprising 25% w / w psilocin tartrate, 62.5% w / w HPMC and 12.5% w / w methyl cellulose.

[0374] 22. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim.

[0375] 23. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the composition is administered:

[0376] Intransally;

[0377] Via inhalation;

[0378] Intravenously;

[0379] Intramuscularly; or

[0380] Subcutaneously.

[0381] 24. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the composition is administered intranasally.

[0382] 25. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the disease or condition is selected from one or more of: major depressive disorder (MDD), moderate to severe MDD, treatment-resistant MDD, major depression, melancholic depression, atypical depression, dysthymia, anxiety, treatment-resistant anxiety, end of life anxiety, generalised anxiety disorder, panic disorder, social anxiety, post-traumatic stress disorder, acute stress disorder, obsessive compulsive disorder, social phobia, substance abuse, alcoholism, tobacco abuse, drug abuse, anorexia nervosa, bulimia nervosa, binge eating disorder, primary impulse-control disorders, and obsessive-compulsive disorder.

[0383] 26. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition without concomitant treatment with one or more further active agents, optionally without concomitant treatment with one or more further active agents selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound; optionally wherein the subject discontinues treatment with the one or more further active agents prior to undergoing treatment with the pharmaceutical composition.

[0384] 27. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents.

[0385] 28. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound.

[0386] 29. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex), Fluoxetine (Prozac, Sarafem), Fluvoxamine (Luvox, Faverin), Paroxetine (Paxil, Seroxat), Sertraline (Zoloft, Lustral), Desven lafaxine (Pristiq), Duloxetine (Cymbalta), Levomilnacipran (Fetzima), Milnacipran (Ixel, Savella), Venlafaxine (Effexor), Vilazodone (Viibryd), Vortioxetine (Trintellix), Nefazodone (Dutonin, Nefadar, Serzone), Trazodone (Desyrel), Reboxetine (Edronax), Teniloxazine (Lucelan, Metatone), Viloxazine (Vivalan), Bupropion (Wellbutrin), Amitriptyline (Elavil, Endep), Amitriptylinoxide (Amioxid, Ambivalon, Equilibria), Clomipramine (Anafranil), Desipramine (Norpramin, Pertofrane), Dibenzepin (Noveril, Victoril), Dimetacrine (Istonil), Dosulepin (Prothiaden), Doxepin (Adapin, Sinequan), Imipramine (Tofranil), Lofepramine (Lomont, Gamanil), Melitracen (Dixeran, Melixeran, Trausabun), Nitroxazepine (Sintamil), Nortriptyline (Pamelor, Aventyl), Noxiptiline (Agedal, Elronon, Nogedal), Opipramol (Insidon), Pipofezine (Azafen / Azaphen), Protriptyline (Vivactil), Trimipramine (Surmontil), Amoxapine (Asendin), Maprotiline (Ludiomil), Mianserin (Tolvon), Mirtazapine (Remeron), Setiptiline (Tecipul), Isocarboxazid (Marplan), Phenelzine (Nardil), Tranylcypromine (Parnate), Selegiline (Eldepryl, Zelapar, Emsam), Caroxazone (Surodil, Timostenil), Metralindole (Inkazan), Moclobemide (Aurorix, Manerix), Pirlindole (Pirazidol), Toloxatone (Humoryl), Agomelatine (Valdoxan), Esketamine (Spravato), Ketamine (Ketalar), Tandospirone (Sediel), Tianeptine (Stabion, Coaxil), Amisulpride (Solian), Aripiprazole (Ability), Brexpiprazole (Rexulti), Lurasidone (Latuda), Olanzapine (Zyprexa), Quetiapine (Seroquel), Risperidone (Risperdal), Trifluoperazine (Stelazine), Buspirone (Buspar), Lithium (Eskalith, Lithobid), Modafinil (Provigil), Thyroxine (T4) and / or Triiodothyronine (T3).

[0387] 30. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are one or more SSRIs.

[0388] 31 . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: citalopram, escitalopram, sertraline, fluoxetine, paroxetine or vilazodone.

[0389] 32. The pharmaceutical composition for use of embodiment 31 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of citalopram.

[0390] 33. The pharmaceutical composition for use of embodiment 31 , wherein the one or more further active agents is 10 or 20 mg once daily of escitalopram.

[0391] 34. The pharmaceutical composition for use of embodiment 31 , wherein the one or more further active agents is 50, 100, 150 or 200 mg once daily of sertraline.

[0392] 35. The pharmaceutical composition for use of embodiment 31 , wherein the one or more further active agents is 10, 20, 30, 40, 50 or 60 mg once daily of fluoxetine.

[0393] 36. The pharmaceutical composition for use of embodiment 31 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of paroxetine.

[0394] 37. The pharmaceutical composition for use of embodiment 31 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of vilazodone. 38. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment comprises the provision of psychological support to the patient.

[0395] 39. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment comprises the provision of psychological support to the patient prior to administration of the pharmaceutical composition.

[0396] 40. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment comprises the provision of psychological support to the patient following administration of the pharmaceutical composition.

[0397] 41 . The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment is a method of treatment of moderate to severe major depressive disorder (MDD).

[0398] 42. The pharmaceutical composition of any one preceding embodiment for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment is a method of treatment of a patient who is diagnosed with major depressive disorder, or moderate to severe major depressive disorder (MDD), by a licensed professional in accordance with accepted medical practice.

[0399] 43. A method of preparing a dry powder pharmaceutical composition comprising a pharmaceutically acceptable salt of psilocin and one or more pharmaceutically acceptable carriers or excipients, wherein said method comprises a dry blending step.

[0400] 44. The method according to embodiment 43, wherein the psilocin salt is psilocin benzoate.

[0401] 45. The method according to embodiment 43, wherein the psilocin salt is psilocin tartrate.

[0402] Herein disclosed, any aspect of the invention, and embodiment(s) of any one aspect of the invention, may be used, adapted, combined or employed in / with any aspect or embodiment(s) of the invention, or in / with any other disclosure made herein.

[0403] Definitions

[0404] To facilitate the understanding of this invention, a number of terms are defined below and throughout the disclosure. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology herein is used to describe specific embodiments of the invention, but their usage does not limit the invention, except as outlined in the claims.

[0405] Terms such as “a”, “an,” and “the” are not intended to refer to only a singular entity but include the general class of which a specific example may be used for illustration.

[0406] As used herein, the term “about” refers to a value that is within 10% above or below the value being described.

[0407] As used herein, the term “cellulose-based excipient” refers to an excipient, such as hydroxypropyl methylcellulose (HPMC) and methylcellulose, which comprise cellulose or its derivatives.

[0408] As used herein, the terms “acute stress disorder” and “ASD” refer to a condition that arises as a response to a stressful event or situation of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in an individual (e.g., natural or man-made disaster, combat, serious accident, witnessing the violent death of others, or being the victim of torture, terrorism, rape, or other crime). Like PTSD, acute stress disorder is an anxiety disorder that involves a very specific reaction following exposure to a traumatic event or stressor. However, the duration of acute stress disorder is shorter than that for PTSD, such that the symptoms are present for at least one, two, or three days, but no more than four, five, or six weeks. For individuals exhibiting symptoms persisting for a longer period of time, a diagnosis of PTSD may be warranted.

[0409] The term “administration” or “administering” refers to a method of giving a dosage of a compound or pharmaceutical composition to a subject.

[0410] By “dysthymia” or “dysthymic disorder” is meant a chronically depressed mood that occurs for most of the day, more days than not, for at least two years. In children and adolescents, the mood may be irritable rather than depressed, and the required minimum duration is one year. During the two-year period (one year for children or adolescents), any symptom-free intervals last no longer than 2 months. During periods of depressed mood, at least two of the following additional symptoms are present: poor appetite or overeating, insomnia or hypersomnia, low energy or fatigue, low self-esteem, poor concentration, or difficulty making decisions, and feelings of hopelessness. The symptoms cause clinically significant distress or impairment in social, occupational (or academic), or other important areas of functioning. The diagnosis of dysthymia is not made if: the individual has ever had a manic episode, a mixed episode, a hypomanic episode; has ever met the criteria for a cyclothymic disorder; the depressive symptoms occur exclusively during the course of a chronic psychotic disorder (e.g., schizophrenia); or if the disturbance is due to the direct physiological effects of a substance or a general medical condition. After the initial two- years of dysthymic disorder, major depressive episodes may be superimposed on the dysthymic disorder (“double depression”). Diagnostic and Statistical Manual of Mental Disorders (OSM IV), American Psychiatric Press, 4th Edition, I 994. Diagnostic guidance for psychological disorders can be found, for example, in the ICD-10 (The ICD-10 Classification of Mental and Behavioral Disorders: Diagnostic Criteria for Research, Geneva: World Health Organization, 1993) and the DSM-V (American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Arlington, VA.; American Psychiatric Association, 2013).

[0411] By “free base equivalent” is meant an amount corresponding to a free base equivalent in a mass of psilocin benzoate. For example, a free base equivalent of 1 mg of psilocin is equal to 1 mg of psilocin in its free base form and equal to 1 .60 mg of psilocin in its benzoate salt form (e.g., 1 ,0x(326.39 / 204.27) to account for the mass contribution of the benzoic acid).

[0412] As used herein, the term “psychological support” may referto one or more of the following: therapy, psychotherapy, talk therapy, cognitive behavioral therapy (CBT), counseling, guided self-help and / or group therapy.

[0413] As used herein, the term “generalized anxiety disorder” refers to a condition characterized by excessive anxiety and worry (i.e., apprehensive expectation). Typically, the excessive anxiety and worry occur on more days than not for a period of time (e.g., one, two, three, or four months or more). The anxiety and worry can be associated with (i) restlessness, feeling keyed up, or on edge; and / or (ii) muscle tension. The anxiety and worry can be associated with (a) a marked avoidance of situations in which a negative outcome could occur; (b) a marked time and effort preparing for situations in which a negative outcome could occur; (c) a marked procrastination in behavior or decision-making due to worries; and (d) repeatedly seeking reassurance due to worries. The anxiety, worry, or physical symptoms can cause clinically significant distress or impairment in social, occupational, or other important areas of functioning in many, but not necessarily all individuals with GAD.

[0414] As used herein, the terms “obsessive compulsive disorder,” “OCD,” and “anxiety and obsessive- compulsive spectrum disorders” refer to a condition characterized by obsessions and / or compulsions. Obsessions are recurrent and persistent thoughts, urges, or images that are experienced, at some time during the disturbance, as intrusive and unwanted and that usually cause marked anxiety or distress in which the obsessed individual attempts to ignore or suppress such thoughts, urges, or images, or to neutralize them with some other thought or action (i.e., by performing a compulsion). Compulsions are repetitive behaviors (e.g., hand washing, ordering, checking) or mental acts (e.g., praying, counting, repeating words silently) that the person feels driven to perform in response to an obsession, or according to rules that must be applied rigidly. The behaviors or mental acts are aimed at preventing or reducing anxiety or distress, or preventing some dreaded event or situation; however, these behaviors or mental acts either are not connected in a realistic way with what they are designed to neutralize or prevent, or are clearly excessive. Typically the obsessions or compulsions are time consuming (for example, take more than 1 hour a day), or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

[0415] As used herein, the term “panic disorder” refers to a condition characterized by recurrent and unexpected panic attacks. Panic disorder includes both panic disorder with agoraphobia and panic disorder without agoraphobia. Subjects with this condition can exhibit one or both of the following: (i) a persistent concern or worry about additional panic attacks or their consequences (e.g., losing control, having a heart attack, going crazy); and / or (ii) significant maladaptive change in behavior related to the attacks (e.g., behaviors designed to avoid having panic attacks), which may include agoraphobic avoidance.

[0416] As used herein, the terms “pharmacologically effective amount,” “therapeutically effective amount,” and the like, when used in reference to a therapeutic composition, refer to a quantity sufficient to, when administered to the subject, including a mammal, for example a human, effect beneficial or desired results, such as clinical results. For example, in the context of treating depression, described herein, these terms refer to an amount of the composition sufficient to achieve a treatment response as compared to the response obtained without administration of the composition. The quantity of a given composition described herein that will correspond to such an amount may vary depending upon various factors, such as the given agent, the pharmaceutical formulation, the route of administration, the type of disease or disorder, the identity of the subject (e.g., age, sex, weight) or host being treated, and the like. An “effective amount,” “pharmacologically effective amount,” or the like, of a composition of the present disclosure, also include an amount that results in a beneficial or desired result in a subject as compared to a control (e.g., a decrease in the score on the Montgomery-Asberg Depression Rating Scale).

[0417] As used herein, the terms “post traumatic stress disorder” and “PTSD” refer to a condition that arises as a delayed and / or protracted response to a stressful event or situation (either short- or long-lasting) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in an individual (e.g., natural or man-made disaster, combat, serious accident, witnessing the violent death of others, or being the victim of torture, terrorism, rape, or other crime). Predisposing factors such as personality traits (e.g., compulsive, asthenic) or previous history of neurotic illness may lowerthe threshold for the development of the condition or aggravate its course, but they are neither necessary nor sufficient to explain its occurrence. PTSD is a less frequent and more enduring consequence of psychological trauma than the more frequently seen acute stress response. PTSD has been recognized in the past as railway spine, stress syndrome, shell shock, battle fatigue, traumatic war neurosis, and post-traumatic stress syndrome. Diagnostic symptoms include re-experiencing original trauma(s), by means of flashbacks or nightmares; avoidance of stimuli associated with the trauma; and increased arousal, such as difficulty falling or staying asleep, anger, and hypervigilance. Formal diagnostic criteria (DSM-V, DSM-IV, and / or ICD-9) require that the symptoms last more than one month and cause significant impairment in social, occupational, or other important areas of functioning (e.g., problems with work and / or relationships). Formal diagnostic criteria can include: (i) intrusion symptoms that are associated with the traumatic event (e.g., (a) spontaneous or cued recurrent, involuntary, and intrusive distressing memories of the traumatic event; (b) recurrent distressing dreams in which the content and / or affect of the dream is related to the event; (c) dissociative reactions (e.g., flashbacks) in which the individual feels or acts as if the traumatic event were recurring (such reactions may occur on a continuum, with the most extreme expression being a complete loss of awareness of present surroundings; (d) intense or prolonged psychological distress at exposure to internal or external cues that symbolize or resemble an embodiment of the traumatic event; and / or (e) marked physiological reactions to reminders of the traumatic event); (ii) persistent avoidance of stimuli associated with the traumatic event (e.g., (a) thoughts, feelings, or physical sensations that arouse recollections of the traumatic event; (b) activities, places, physical reminders, or times (e.g., anniversary reactions) that arouse recollections of the traumatic event; and / or (c) people, conversations, or interpersonal situations that arouse recollections of the traumatic event); (iii) negative alterations in cognitions and mood that are associated with the traumatic event (e.g., (a) inability to remember an important embodiment of the traumatic event (typically dissociative amnesia); (b) persistent and exaggerated negative expectations about one’s self, others, or the world; (c) persistent distorted blame of self or others about the cause or consequences of the traumatic event; (d) pervasive negative emotional state (e.g., fear, horror, anger, guilt, or shame); (e) markedly diminished interest or participation in significant activities; (f) feeling of detachment or estrangement from others; and / or (g) persistent inability to experience positive emotions (e.g., unable to have loving feelings, psychic numbing); and (iv) alterations in arousal (i.e., hyperarousal) and reactivity that are associated with the traumatic event (e.g., (a) irritable, angry, or aggressive behavior; (b) reckless or self-destructive behavior; (c) hypervigilance; (d) exaggerated startle response; (e) problems with concentration; and / or (f) sleep disturbance (e.g., difficulty falling or staying asleep, or restless sleep)). Formal diagnostic criteria can further include that the duration of disturbance is more than a certain period of time (e.g., one month, three months, or six months) and that the disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning. In a small proportion of patients the condition may show a chronic course over many years and a transition to an enduring personality change. The three main symptoms associated with PTSD are (1) “reliving” the traumatic event, such as flashbacks, nightmares, intrusive thoughts and recollections, (2) avoidance behaviors and emotional numbing, and (3) hypersensitivity such as an inability to sleep, anxious feelings, overactive startle response, hyperarousal, hypervigilance, irritability, and outbursts of anger.

[0418] As used herein, the terms “psychological disorder” and “psychological condition” referto a condition characterized by a disturbance in one’s emotional or behavioral regulation that reflects a dysfunction in the psychological, biological, or developmental processes underlying mental function. Psychological disorders include, but are not limited to depressive disorders (major depression, treatment resistant depression, melancholic depression, atypical depression, or dysthymia), anxiety disorders (end of life anxiety, generalized anxiety disorder, panic disorder, social anxiety, post-traumatic stress disorder, acute stress disorder, obsessive compulsive disorder, or social phobia), addictions (e.g., substance abuse, e.g., alcoholism, tobacco abuse, or drug abuse)), eating disorders (e.g., anorexia nervosa, bulimia nervosa, and binge eating disorder) and compulsive behavior disorders (e.g., primary impulse-control disorders or obsessive-compulsive disorder). Psychological disorders can be any psychological condition associated with one or more symptoms, e.g., somatic symptoms (e.g., chronic pain, anxiety disproportionate to severity of physical complaints, pain disorder, body dysmorphia, conversion (i.e., loss of bodily function due to anxiety), hysteria, or neurological conditions without identifiable cause), or psychosomatic symptoms (e.g., back pain, fibromyalgia, migraines, and chronic fatigue syndrome). Psychological disorders also include repetitive body-focused behaviors, such as tic disorders (e.g., Tourette's Syndrome, trichotillomania, nail- biting, temporomandibular disorder, thumb-sucking, repetitive oral-digital, lip-biting, fingernail biting, eyerubbing, skin-picking, or a chronic motor tic disorder). In some cases, development of a psychological disorder is associated with or characterized by a prodromal symptom, such as depressed mood, decreased appetite, weight loss, increased appetite, weight gain, initial insomnia, middle insomnia, early waking, hypersomnia, decreased energy, decreased interest or pleasure, self-blame, decreased concentration, indecision, suicidality, psychomotor agitation, psychomotor retardation, crying more frequently, inability to cry, hopelessness, worrying / brooding, decreased self-esteem, irritability, dependency, self-pity, somatic complaints, decreased effectiveness, helplessness, and decreased initiation of voluntary responses.

[0419] As used herein, the terms “social phobia” and “social anxiety disorder” refer to a condition characterized by fear or anxiety associated with one or more social situations. Subjects with this condition typically exhibit a marked fear or anxiety about one or more social situations in which the person is exposed to possible scrutiny by others. Examples include social interactions (e.g., having a conversation), being observed (e.g., eating or drinking), or performance in front of others (e.g., giving a speech). Typically, an individual with this condition (i) fears that he or she will act in a way, or show anxiety symptoms that will be negatively evaluated (i.e., be humiliating, embarrassing, lead to rejection, or offend others); (ii) the social situations almost invariably provoke immediate fear or anxiety; (iii) the social situations are avoided or endured with intense fear or anxiety; and (iv) the fear or anxiety is out of proportion to the danger posed by the social situation. In children, the fear or anxiety may be expressed by crying, tantrums, freezing, clinging, shrinking or refusal to speak in social situations. The fear, anxiety, and avoidance can cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

[0420] As used herein, the terms “treat,” “treating,” or “treatment” refer to administration of a compound or pharmaceutical composition for a therapeutic purpose. To “treat a disorder” or use for “therapeutic treatment” refers to administering treatment to a patient already suffering from a disease to ameliorate the disease or one or more symptoms thereof to improve the patient’s condition (e.g., by reducing one or more symptoms of inflammation). The term “therapeutic” includes the effect of mitigating deleterious clinical effects of certain inflammatory processes (i.e., consequences of the inflammation, rather than the symptoms of inflammation). The methods of the invention can be used as a primary prevention measure, i.e., to prevent a condition orto reduce the risk of developing a condition. Prevention refers to prophylactic treatment of a patient who may not have fully developed a condition or disorder, but who is susceptible to, or otherwise at risk of, the condition. Thus, in the claims and embodiments, the methods of the invention can be used either for therapeutic or prophylactic purposes.

[0421] By “major depressive disorder” is meant a clinical course that is characterized by one or more major depressive episodes in an individual without a history of manic, mixed, or hypomanic episodes. The diagnosis of unipolar depression is not made if: manic, mixed, or hypomanic episodes develop during the course of depression; if the depression is due to the direct physiological effects of a substance; if the depression is due to the direct physiological effects of a general medical condition; if the depression is due to a bereavement or other significant loss (“reactive depression”); or if the episodes are better accounted for by schizoaffective disorder and are not superimposed on schizophrenia, schizophreniform disorder, delusional disorder, or psychotic disorder. If manic, mixed, or hypomanic episodes develop, then the diagnosis is changed to a bipolar disorder. Depression may be associated with chronic general medical conditions (e.g., diabetes, myocardial infarction, carcinoma, and stroke). Generally, unipolar depression is more severe than dysthymia. The essential feature of a major depressive episode is a period of at least two to 15 weeks during which there is either depressed mood or loss of interest or pleasure in nearly all activities. In children and adolescents, the mood may be irritable rather than sad. The episode may be a single episode or may be recurrent. The individual also experiences at least four additional symptoms drawn from a list that includes changes in appetite or weight, sleep, and psychomotor activity; decreased energy; feelings of worthlessness or guilt; difficulty thinking, concentrating, or making decisions; or recurrent thoughts of death or suicidal ideation, plans, or attempts. Each symptom must be newly present or must have clearly worsened compared with the person's pre-episode status. The symptoms must persist for most of the day, nearly every day, for at least two consecutive weeks, and the episode must be accompanied by clinically significant distress or impairment in social, occupational (or academic), or other important areas of functioning (Diagnostic and Statistical Manual of Mental Disorders (OSM IV), American Psychiatric Press, 4th Edition, 1994). Diagnostic guidance for psychological disorders can be found, for example, in the ICD-10 (The ICD-10 Classification of Mental and Behavioral Disorders: Diagnostic Criteria for Research, Geneva: World Health Organization, 1993) and the DSM-V (American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Arlington, VA.; American Psychiatric Association, 2013).

[0422] Other features and advantages of the invention will be apparent from the following Detailed Description, Examples, Figures and Claims.

[0423] BRIEF DESCRIPTION OF THE DRAWINGS

[0424] The following drawings form part of the present specification and are included to further demonstrate certain embodiments of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of specific embodiments presented herein.

[0425] Fig. 1 shows the mean psilocin plasma concentration (ng / mL) against time for each of the test items (Example B2).

[0426] Fig. 2 shows the mean psilocin plasma concentration (ng / mL) against time for each of T2, T3 and T4 (Example B2).

[0427] Fig. 3 shows the dissolution profile of psilocin benzoate (dry blended and spray dried) stored at 25°C / 60%RH (Table C1 and C3).

[0428] Fig. 4 shows the dissolution profile of psilocin benzoate (dry blended and spray dried) stored at 40°C / 75%RH (Table C2 and C4).

[0429] Fig. 5 shows the dissolution profile of psilocin tartrate (dry blended and spray dried) stored at 25°C / 60%RH (Table C5 and C7).

[0430] Fig. 6 shows the dissolution profile of psilocin tartrate (dry blended and spray dried) stored at 40°C / 75%RH (Table C6 and C8).

[0431] Fig. 7 shows all data in Tables C1 to C8.

[0432] Fig. 8 shows all dissolution data collected on the psilocin benzoate and psilocin tartrate salts.

[0433] DETAILED DESCRIPTION OF THE INVENTION

[0434] Treatment Methods The disclosure provides psilocin salt forms useful for treating psychological conditions, neurological injuries, pain, cephalic pain (e.g., headache), inflammatory conditions, and anxiety.

[0435] Psychological Conditions

[0436] The pharmaceutical compositions comprising psilocin, or a psilocin freebase equivalent of a pharmaceutically acceptable salt thereof, of the invention can be used to treat psychological conditions. The psychological condition may be any psychological condition described herein. In some embodiments the psychological condition is depression, anxiety, addiction, post-traumatic stress disorder (PTSD), an eating disorder, or compulsive behavior. In some embodiments, the psychological condition may be depression. The psychological condition may also be anxiety. The anxiety may be experienced by a subject who is receiving palliative care or is enrolled in a hospice program. In certain embodiments, the subject who is experiencing anxiety has symptoms such as hypervigilance, fatigue, racing thoughts, irritability, excessive worry, and / or fear.

[0437] The subject diagnosed with a psychological condition may be diagnosed by evaluation of the subject’s symptoms by a physician, clinician, or therapist based on a physical examination. For example, a blood test may be used to evaluate blood concentration levels of certain biomarkers such as hormones, calcium, vitamin D, electrolytes, and iron in diagnosing depression. Additionally, or alternatively, for patients with a possible depression condition a depression screening test may be performed by the physician, clinician, or therapist to aid in the diagnosis of depression. In some embodiments, the methods described herein may be used to treat psychosomatic pain conditions. In some embodiments, the psychosomatic pain condition may be fibromyalgia, chronic fatigue, migraines, or back pain.

[0438] Neurological Injuries

[0439] The pharmaceutical compositions comprising psilocin, or a psilocin freebase equivalent of a pharmaceutically acceptable salt thereof, of the invention can be used to treat a neurological injury. The neurological injury may be any neurological injury. In some embodiments, the neurological injury is a stroke, a traumatic brain injury, or a spinal cord injury. The methods of treating a neurological injury described herein may reduce acute inflammation. In certain embodiments, hippocampal hyperactivity is reduced. In particular embodiments, the methods of the invention are used to treat a neurological injury, e.g., stroke, traumatic brain injury, and spinal cord injury, by administering the pharmaceutical compositions comprising psilocin, or a psilocin freebase equivalent of a pharmaceutically acceptable salt thereof, as needed to pain, inflammation, and / or other symptoms associated with the neurological injury.

[0440] Neurodegenerative Conditions

[0441] The pharmaceutical compositions comprising psilocin, or a psilocin freebase equivalent of a pharmaceutically acceptable salt thereof, of the invention can be used to treat neurodegenerative conditions. The neurodegenerative condition to be treated can be Alzheimer’s disease, Huntington’s disease, or Parkinson’s disease, among others.

[0442] Inflammatory Conditions The pharmaceutical compositions comprising psilocin, or a psilocin freebase equivalent of a pharmaceutically acceptable salt thereof, of the invention can be used to treat inflammatory conditions. The inflammatory condition to be treated can be a lung inflammation (e.g., chronic obstructive pulmonary disease (COPD)), neuroinflammation (e.g., inflammation associated with Alzheimer’s disease), chronic inflammation, rheumatoid arthritis, atherosclerosis, psoriasis, type II diabetes, inflammatory bowel disease, Crohn’s disease, multiple sclerosis, and / or septicemia.

[0443] Chronic Pain

[0444] The pharmaceutical compositions comprising psilocin, or a psilocin freebase equivalent of a pharmaceutically acceptable salt thereof, of the invention can be used to treat conditions associated with chronic pain. The chronic pain may result from post-operative pain, tension headaches, chronic lower back pain, fibromyalgia, nephropathy, multiple sclerosis, shingles, complex regional pain syndrome, cephalic pain, or sciatica. The chronic pain may arise from an operation. The chronic pain may also be pain associated with a particular disease or condition such as nephropathy, multiple sclerosis, shingles, or complex regional pain syndrome. As used herein, a disorder or condition associated with cephalic pain is a disorder or condition which has as one of its symptoms cephalic / head pain (e.g., headache). Examples of such disorders or conditions include trigeminal autonomic cephalalgias such as episodic and chronic cluster headache (CH), episodic and chronic paroxysmal hemicrania (PH), and short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT). Other examples of disorders or conditions which can be treated according to the present invention include vascular headaches (e.g., migraine headaches), tension headaches, headaches associated with the use of a substance (e.g., triptans such as sumatriptan, benzodiazepines such as alprazolam, analgesics such as ibuprofen, ergots such as ergotamine, opioids such as morphine, recreational drugs such as caffeine, nicotine, alcohol, and hormone replacement therapy containing, for example, estrogen) or its withdrawal. Yet additional examples of disorders or conditions associated with cephalic pain include miscellaneous headache unassociated with a structural lesion, headache associated with a nonvascular intracranial disorder, headache associated with a non- cephalic infection, headache associated with a metabolic disorder, headache associated with a disorder of the cranium, neck, eyes, nose, sinuses, teeth, mouth, or other facial or cranial structure, nerve trunk pain and deafferentation pain.

[0445] Compositions

[0446] The invention features pharmaceutical compositions including a psilocin salt form of the invention and a pharmaceutically acceptable excipient.

[0447] In an embodiment, the pharmaceutical composition comprises a psilocin salt wherein the salt anion is selected from: acetate, aspartate, benzenesulfonate, benzoate, besylate, bicarbonate, bitartrate, bromide, camsylate, carbonate, chloride, citrate, decanoate, edetate, estolate, esylate, fumarate, gluceptate, gluconate, glutamate, glycolate, glycollylarsanilate, hexanoate, hexylresorcinate, hydrabamine, hydroxynaphthoate, iodide, isethionate, isethionate, lactate, lactobionate, malate, maleate, mandelate, mesylate, methylbromide, methylnitrate, methylsulfate, mucate, napsylate, nitrate, octanoate, oleate, pamoate, pantothenate, phosphate, polygalacturonate, propionate, salicylate, stearate, subacetate, succinate, sulfate, tartrate, teoclate, tosylate, and triethiodide.

[0448] Examples of a pharmaceutically acceptable excipients include, but are not limited to, biocompatible vehicles, adjuvants, additives, and diluents to achieve a composition usable as a dosage form. Examples of other excipients include colloidal silicon oxide, magnesium stearate, cellulose, sodium lauryl sulfate, and D&C Yellow # 10.

[0449] The pharmaceutical compositions of the invention can include one or more solvents, diluents, or other liquid vehicle, dispersion or suspension aids, surface active agents, isotonic agents, thickening or emulsifying agents, preservatives, solid binders, and lubricants, as suited to the particular dosage form desired. Remington’s Pharmaceutical Sciences, Eighteenth Edition, E. W. Martin (Mack Publishing Co., Easton, Pa., 1990) discloses various excipients used in formulating pharmaceutical compositions and known techniques for the preparation thereof. Except insofar as any conventional excipient medium is incompatible with the compounds of the invention, such as by producing any undesirable biological effect or otherwise interacting in a deleterious manner with any other component(s) of the pharmaceutical composition, its use is contemplated to be within the scope of this invention. Some examples of materials which can serve as pharmaceutically acceptable excipients include, but are not limited to, sugars such as lactose, glucose and sucrose; starches such as corn starch and potato starch; cellulose and its derivatives such as sodium carboxymethylcellulose, ethyl cellulose and cellulose acetate; powdered tragacanth; malt; gelatin; talc; excipients such as cocoa butter and suppository waxes; oils such as peanut oil, cottonseed oil; safflower oil, sesame oil; olive oil; corn oil and soybean oil; glycols; such as propylene glycol; esters such as ethyl oleate and ethyl laurate; agar; natural and synthetic phospholipids, such as soybean and egg yolk phosphatides, lecithin, hydrogenated soy lecithin, dimyristoyl lecithin, dipalmitoyl lecithin, distearoyl lecithin, dioleoyl lecithin, hydroxylated lecithin, lysophosphatidylcholine, cardiolipin, sphingomyelin, phosphatidylcholine, phosphatidyl ethanolamine, diastearoyl phosphatidylethanolamine (DSPE) and its pegylated esters, such as DSPE-PEG750 and, DSPE-PEG2000, phosphatidic acid, phosphatidyl glycerol and phosphatidyl serine; and hydroxypropyl-beta-cyclodextrin and sulfonic acid substituted cyclodextrin (e.g., CAPTISOL™). Commercial grades of lecithin which are preferred include those which are available under the trade name Phosal® or Phospholipon® and include Phosal 53 MCT, Phosal 50 PG, Phosal 75 SA, Phospholipon 90H, Phospholipon 90G and Phospholipon 90 NG; soy-phosphatidylcholine (SoyPC) and DSPE-PEG2000 are particularly preferred; buffering agents such as magnesium hydroxide and aluminum hydroxide; alginic acid; pyrogen-free water; isotonic saline; Ringer’s solution; 5% dextrose solution and combinations with the foregoing aqueous solutions; ethyl alcohol, and phosphate buffer solutions, as well as other non-toxic compatible lubricants such as sodium lauryl sulfate and magnesium stearate, as well as coloring agents, releasing agents, coating agents, sweetening, flavoring and perfuming agents, preservatives and antioxidants can also be present in the composition, according to the judgment of the formulator.

[0450] Hydroxypropyl methylcellulose (HPMC) or hypromellose refers to soluble methylcellulose ethers and is approved as an inactive ingredient. Without being bound by theory, HPMC is believed to act as a viscosity enhancer, and delays / slows mucociliary clearance. HPMC polymers for fabricating hydrophilic matrix systems are available in various viscosity grades ranging from 4000-100,000 millipascal-second (mPa«s). The polymer chain length, size and degree of branching determine the viscosity of the polymer in solution.

[0451] Different grades of HPMC (with lower viscosities than that above) are also available according to their particle size distribution, viscosity, molecular weights, and substitution of methoxy and hydroxypropyl groups.

[0452] The HPMC in compositions of the invention can be selected to function as a binder, film former, and / or hydrophilic matrix material. HPMC polymers for fabricating hydrophilic matrix systems are available in various viscosity grades. The viscosity of the HPMC may be measured at 20 °C in an aqueous solution of 2 % (w / w). In certain instances, the viscosity of the HPMC may be measured at 2 % (w / v) in an aqueous solution at 20 °C. The pharmaceutical compositions of the invention can be tuned / controlled by selection of a suitable molecular weight of polymer.

[0453] In some embodiments, the pharmaceutical composition comprises a polymer(s) having a low viscosity grade, e.g., a low molecular weight, such as a weight average molecular weight of less than or equal to 100,000 g / mol, less than or equal to 90,000 g / mol, less than or equal to 80,000 g / mol, less than or equal to 70,000 g / mol, less than or equal to 60,000 g / mol, less than or equal to 50,000 g / mol, less than or equal to 40,000 g / mol, less than or equal to 30,000 g / mol, less than or equal to 20,000 g / mol, less than or equal to 15,000 g / mol. Typically, the lower limit of weight average molecular weight for low viscosity grade polymers may be from 1 ,000 g / mol, from 2,000 g / mol, from 4,000 g / mol, from 6,000 g / mol, from 8,000 g / mol, from 10,000 g / mol, from 12,000 g / mol, from 14,000 g / mol. In some embodiments, the low molecular weight polymer is a low molecular weight HPMC polymer, having a molecular weight within the above recite range, alone or as a polymer blend. Examples of a low molecular weight HPMC polymers which can be used herein include, but are not limited to, AFFINISOL™ HPMC HME 15LV (water soluble; amorphous HPMC polymer with a molecular weight of less than 100 kDa; bulk density of 0.42 g / cc; D(0.5) of 104.49 pm), METHOCEL™ E3 LV (2910 substitution type: 28-30% methoxy substitution, 7-12% hydroxypropyl substitution; viscosity of 4.0-6.0 mPa«s as 2% solution in water at 20 °C), METHOCEL™ E6 premium LV (70,000-80,000 g / mol, 2910 substitution type: 28-30% methoxy substitution, 7-12% hydroxypropyl substitution; viscosity of 4.8-7.2 mPa- s as 2% solution in water at 20°C), each available from DuPont, and PHARMACOAT® 606 (2910 substitution type: 28- 30% methoxy substitution, 7-12% hydroxypropyl substitution; viscosity of 6.0 mPa«s as 2% solution in water at 20°C), available from Shin-Etsu Chemical Co. Ltd. The selection of a low molecular weight polymer may provide pharmaceutical compositions adapted for immediate release or fast release of the psilocin. For example, immediate release may refer to dosage forms which release greater than 80 wt.% of the active ingredient within about 1 minute following administration, while the phrase fast release may refer to dosage forms in which the release of 80 wt.% of the active ingredient takes place in a range of about 1 minute to about 5 minutes following administration. While not limited to specific manufacturing techniques, pharmaceutical compositions comprising a low molecular weight polymer or polymer blend may be advantageously suited for freeze drying, dry blending or spray drying preparation methods. For the purposes of this application a low viscosity HPMC would generally be considered to be one with a viscosity grade of less than 20mPa«s. In an embodiment, the low viscosity HPMC has a viscosity less than about 20, 15, 10, 5, 1 mPa«s optionally where the HPMC is a HPMC containing about 7.0-12.0% (e.g., 7%±1 %, 8%±1 %, 9%±1 %, 10%±1 %, 11 %±1 %, or 12%±1 %) hydroxypropyl content, about 28.0-30.0% (e.g., 28%±2%, 29%±2%, or 30%±2%) methoxy content, and a viscosity of about 4.8-7.2 (e.g., 4.8±0.5, 5.3±0.5, 5.7±0.5, 6.2±0.5, 6.7±0.5, 7±0.5, or 7.2±0.5) mPa«s.

[0454] Different grades of HPMC (with lower viscosities than that above) are also available according to their particle size distribution, viscosity, molecular weights, and substitution of methoxy and hydroxypropyl groups.

[0455] The HPMC in compositions of the invention can be selected to function as a binder, film former, and / or hydrophilic matrix material. HPMC polymers for fabricating hydrophilic matrix systems are available in various viscosity grades.

[0456] In some embodiments, the pharmaceutical composition comprises a polymer(s) having a high viscosity grade, e.g., a high molecular weight, such as a weight average molecular weight of greater than or equal to 100,000 g / mol, greater than or equal to 110,000 g / mol, greater than or equal to 120,000 g / mol, greater than or equal to 130,000 g / mol, greater than or equal to 140,000 g / mol or greater than or equal to 150,000 g / mol. methylcellulose or methylcellulose is not naturally occurring and may be produced by heating cellulose with a caustic solution followed by treatment with methyl chloride. Different kinds of methylcellulose may be prepared depending on the number of hydroxyl groups substituted. One example of methylcellulose is metolose ® SM 100 or methylcellulose SM 100 available from Shin-Etsu Chemical Co. Ltd. The typical properties of methylcellulose SM 100 are a methoxy content of 26-33%, a viscosity of 80-120 (100) mPa«s, a true density of 1 .26-1 .31 g / ml, a tapped density of 0.35-0.65 g / ml and a degradation temperature of 280-300°C. The viscosity is measured with 2% aqueous solution at 20°C. SM 100 has an average molecular weight of 100,000 g / mol. In an embodiment, SM 100 is an example of a high molecular weight / high viscosity grade cellulose-based excipient.

[0457] The above-described compositions, in any of the forms described above, can be used for treating a disease or condition described herein. An effective amount refers to the amount of an active compound / agent that is required to confer a therapeutic effect on a treated subject. Effective doses will vary, as recognized by those skilled in the art, depending on the types of diseases treated, route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatment.

[0458] A pharmaceutical composition of this invention can be administered parenterally, orally, nasally, rectally, topically, or buccally. The term “parenteral” as used herein refers to subcutaneous, intracutaneous, intravenous, intramuscular, intraarticular, intraarterial, intrasynovial, intrasternal, intrathecal, intralesional, or intracranial injection, as well as any suitable infusion technique. EXAMPLES

[0459] Example A1. Dry Blend Compositions of Psilocin

[0460] Two dry blend compositions were made at a 7g scale, one loaded with the benzoate salt of psilocin and one with the tartrate salt of psilocin. Both compositions were comprised of 25% of the respective psilocin salt, 62.5% of HPMC 606 (Pharmacoat) and 12.5% of methylcellulose (SM-100).

[0461] All ingredients of the blend were weighed out on an analytical scale and transferred directly to a 60mL amber glass jar. The polymers were weighed first, followed by the active (psilocin salt). The psilocin tartrate was hand milled using pestle and mortar and passed through a 250pm sieve prior to blending.

[0462] The prepared mixtures were blended in bulk for 5 min each at 32 rpm using a Turbula blender.

[0463] Each of the blends was then split into 12 x 7 mL scintillation vials filled with ~500 mg of blend, with an exception of the control vials, which were filled with whatever blend was remaining, yielding ~800-1000 mg fill weight.

[0464] For each of the blends, the vials were as follows:

[0465] 2x plain powder control

[0466] 2x 1 % w / w Silicon Dioxide (SiC>2)

[0467] 2x 5% w / w Microcrystalline Cellulose (MCC)

[0468] 2x 1 % w / w Calcium Silicate (CaSiCh)

[0469] 2x 1 % w / w Sodium Stearyl Fumarate (SSF)

[0470] 2x 1 % w / w Magnesium Stearate (Mg Stearate)

[0471] Example A2. Stability testing of Dry Blend Compositions of Psilocin

[0472] Following visual observations and photos at T=0, one of each of the vials of Example A1 were put on storage at 25°C / 60%RH and one of each at 40°C / 75%RH.

[0473] Following storage for 1 week, the following visual observations were seen for the psilocin benzoate compositions:

[0474] • Control - 25°C / 60%RH - Slightly settled, but uncaked. Flowed after tilting and rotating the vial. A small amount of powder was stuck in the edges at the bottom of the vial; this was easily detached with a tap.

[0475] • Control - 40°C / 75%RH - Caking was observed, which initially broke off in layers but required force to break fully. Flow was observed but with small aggregates. A small amount of powder was stuck at the bottom of the vial and could not be removed with tapping.

[0476] • SiC>2 - 25°C / 60%RH - No caking or settling was observed. Flow was apparent immediately with very little powder observed to stick in the edges at the bottom of the vial, which was easily detached with tapping. The walls of the vial were much cleaner of fine powder residues when compared to the control. • SiC>2 - 40°C / 75%RH - Uniform appearance, settling present but uncaked. Flow was apparent almost immediately. A small amount of powder was observed to stick at the bottom of the vial, which was easily detached with tapping.

[0477] • MCC - 25°C / 60%RH - Some layering of the composition was present with substantial powder observed to be stuck at the bottom of the vial. This powder was detachable but with difficulty.

[0478] • MCC - 40°C / 75%RH - Uniform appearance, similar to 25°C / 60%RH. Settling was observed with the absence of caking. The powder flowed well. A small amount of powder was observed to stick at the bottom of the vial, which was easily detached with tapping.

[0479] • CaSiOs - 25°C / 60%RH - Slightly improved flow when compared to the control.

[0480] • CaSiOs - 40°C / 75%RH - Very slight layering was observed, with the composition settled but uncaked. The powder flowed well straight away. A small amount of powder was observed to stick at the bottom of the vial, which was detachable with varying amounts of force.

[0481] • SSF - 25°C / 60%RH - Some layering was present with the composition settled but not caked. The composition flowed almost immediately after tilting the vial. The flow was similar or slightly better when compared to the control. A small amount of powder was observed to stick at the bottom of the vial, which was easily detached with tapping.

[0482] • SSF - 40°C / 75%RH - Very slight layering was observed, with the composition settled in layers which quickly broke. The walls of the vial were observed to be coated with a fine powder. Any powder observed to stick at the bottom of the vial was detachable with a tap.

[0483] • Mg Stearate - 25°C / 60%RH - The composition appeared uniform with slight settling observed. Flow was immediately observed. A small amount of powder was observed to stick at the bottom of the vial, which was easily detached with tapping. The walls of the vial were much cleaner of fine powder when compared to the control.

[0484] • Mg Stearate - 40°C / 75%RH - The composition was mostly uniform in appearance, with settling observed which broke in layers almost immediately. Very little powder was observed to be stuck to the bottom of the vial, with the absence of fine powder on vial walls and good powder flow.

[0485] Following storage for 2 weeks, the following visual observations were seen for the psilocin benzoate compositions:

[0486] • Control - 25°C / 60%RH - The composition was mostly uniform in appearance, with settling observed which broke in layers gradually upon tilting and eventually inverting the vial. Flow was observed alongside a small amount of powder observed to be stuck to the bottom of the vial, which was easily detached with tapping.

[0487] • Control - 40°C / 75%RH - The composition was mostly uniform in appearance or minimally layered. Settling or slight caking was observed, which broke off in multiple layers upon tilting the vial. A small amount of powder was observed to be stuck to the bottom of the vial, which was detached with forceful tapping. Flow was observed but poorer flow than the 25°C / 60%RH control with small aggregates observed.

[0488] • SiC>2 - 25°C / 60%RH - The composition was mostly uniform in appearance with slight settling observed, which broke as a whole. The powder was free flowing with the walls of the vial observed to be much freer of fine powder compared to the control. Very little powder was observed stuck to the bottom of the vial. • SiC>2 - 40°C / 75%RH - The composition was mostly uniform in appearance and flowed as soon as the vial was titled, with only one or two small aggregates present. The walls of the vial were observed to be much freer of fine powder compared to the control. Very little powder was observed stuck to the bottom of the vial.

[0489] • MCC - 25°C / 60%RH - The composition appeared uniform, with settling observed which broke in layers upon tilting and rotating the vial. A fair amount of powder remains stuck in the edges at the bottom of the vial, which is removable with tapping. Fine powder was observed to coat the walls of the vial.

[0490] • MCC - 40°C / 75%RH - The composition appeared uniform, with settling observed which broke and flowed as soon as the vial was tilted but which left a large amount of powder stuck at the bottom of the vial. This was removable with tapping.

[0491] • CaSiOs - 25°C / 60%RH - The composition appeared uniform, with settling observed which broke as a whole upon tilting and rotating the vial. A fair amount of powder was stuck in the edges at the bottom of the vial. This was removable with tapping. The powder was otherwise free-flowing.

[0492] • CaSiOs - 40°C / 75%RH - The composition appeared uniform, with settling observed which broke as a whole upon tilting and rotating the vial. A fair amount of powder was stuck in the edges at the bottom of the vial. This was removable with tapping. The powder flowed well, similarly to the control, but with the absence of aggregates.

[0493] • SSF - 25°C / 60%RH - The composition appeared uniform, with slight settling observed which broke as a whole upon tilting and rotating the vial. The powder flowed, almost identically to the control. Large amount of fine powder was observed to be coating the walls of the vial.

[0494] • SSF - 40°C / 75%RH - Slight layering was observed, alongside settling, in the same manner as the calcium silicate sample. Any powder stuck at the bottom of the vial could be detached easily with tapping. Flow without aggregates was observed.

[0495] • Mg Stearate - 25°C / 60%RH - Some slight layering was observed to be present, but the powder was almost unsettled and broke straight away with good flow observed. Little to no sticking of powder to the bottom of the vial was observed. The walls of the vial were noticeably cleaner of fine powder.

[0496] • Mg Stearate - 40°C / 75%RH - The composition appeared uniform, with settling observed which broke in layers upon tilting and rotating the vial. Little to no sticking of powder to the bottom of the vial was observed. The walls of the vial were noticeably cleaner of fine powder and the powder flowed very well.

[0497] Following storage for 1 week, the following visual observations were seen for the psilocin tartrate compositions:

[0498] • Control - 25°C / 60%RH - Some layering was present. Slight caking was observed which broke off in layers upon tilting the vial. The composition flowed well thereafter.

[0499] • Control - 40°C / 75%RH - Some layering was present. Slight caking was observed which required several taps to break it. The composition flowed well thereafter with small aggregates. Some powder was found to stick at the bottom of the vial and it was not possible to remove this powder with tapping. • SiC>2 - 25°C / 60%RH - The composition had caked. This cake broke as a whole upon tilting of the vial and the powder flowed well thereafter. There was very little sticking observed at the bottom of the vial. The walls of the vial were observed to be much cleaner of fine powder when compared to the control.

[0500] • SiC>2 - 40°C / 75%RH - The composition was mostly uniform in appearance, with tapping required to break caking which was observed, with good flow thereafter. Some powder was found to stick at the bottom of the vial and it was not possible to remove this powder with tapping. The walls of the vial were observed to be much cleaner of fine powder when compared to the control.

[0501] • MCC - 25°C / 60%RH - The composition appeared uniform, with the walls of the vial uniformly coated with a fine powder. The composition had caked, however, this broke easily with good flow observed thereafter.

[0502] • MCC - 40°C / 75%RH - Some layering was present, however, this was to a lesser degree than with the control. Otherwise, this was identical to the control.

[0503] • CaSiOs - 25°C / 60%RH - Some layering was present, but the composition was uncaked with slight settling observed. The composition flowed well straight away upon turning the vial. A small amount of powder was observed to stick at the bottom of the vial, which was easily detached with tapping.

[0504] • CaSiOs - 40°C / 75%RH - Some layering was present with caking observed. The initial layer of powder detached on its own, but force was required to break the remnants. Flow was present, however, this was with aggregates.

[0505] • SSF - 25°C / 60%RH - The composition appeared uniform, no caking was present. Some powder was found to stick at the bottom of the vial and it was possible to remove this powder with tapping. The walls of the vial were observed to be much cleaner of fine powder when compared to the control, however, powder remnants were seen on the walls of the vial following flow.

[0506] • SSF - 40°C / 75%RH - Some layering was observed, however, very little. Settling of the powder was observed, with good flow. A large amount of powder was found to stick at the bottom of the vial and it was possible to remove most of this powder with tapping.

[0507] • Mg Stearate - 25°C / 60%RH - Mostly uniform, settled but uncaked. Flow was almost instantaneous.

[0508] • Mg Stearate - 40°C / 75%RH - The composition appeared uniform, with caking present which required force to break. Large amount of fine powder was observed to coat the walls of the vial. Some powder was found to stick at the bottom of the vial and it was not possible to remove this powder with tapping.

[0509] Following storage for 2 weeks, the following visual observations were seen for the psilocin tartrate compositions:

[0510] • Control - 25°C / 60%RH - A small amount of light layering was present with the powder settled or slightly caked. This broke into two layers but flowed after this with fine powder coating the walls of the vial. Some powder was found to stick at the bottom of the vial and it was possible to remove this powder with tapping.

[0511] • Control - 40°C / 75%RH - Layering and segregation of the powder was observed with the powder fully caked. This broke off in layers but only after significant tapping was undertaken. Some powder was found to stick at the bottom of the vial and it was not possible to remove this powder with tapping. Flow was present but with aggregates also present and a large amount of fine powder on the walls of the vial. A slight color change in the form of a darkening of the powder was also observed.

[0512] • SiC>2 - 25°C / 60%RH - The composition appeared uniform, no caking was present. Slight settling was observed which broke into two layers with good flow observed. Little to no sticking was observed at the bottom of the vial. Powder flow left a residue of fine powder on the walls of the vial which was detachable with a tap.

[0513] • SiC>2 - 40°C / 75%RH - The composition appeared uniform or minimally layered. Caking was observed which required a few strong taps to break. This left behind a layer of powder stuck in the edges of the bottom of the vial which could not be detached with tapping. Good flow was observed with very small aggregates present. The walls of the vial were observed to be much cleaner. A color change was observed in the form of a slight darkening of the powder.

[0514] • MCC - 25°C / 60%RH - The composition appeared uniform or minimally layered. Slightly settled but broke into layers, similar to the control. A fair amount of powder sticks in the edges at the bottom of the vial, but this was detached easily with tapping. An even layer of fine powder coated the walls of the vial.

[0515] • MCC - 40°C / 75%RH - Layering was present alongside caking. A single tap was required to break the caking. A small amount of powder was left behind stuck in the edges at the bottom of the vial and it was not possible to remove this with tapping. The powder flowed well but some aggregates remained alongside a layer of fine powder on the walls.

[0516] • CaSiOs - 25°C / 60%RH - The composition appeared uniform with very good flow observed. A fair amount of powder was observed to stick in the edges at the bottom of the vial which could be detached easily with tapping.

[0517] • CaSiOs - 40°C / 75%RH - Slight layering was observed alongside caking which broke after one tap and turning of the vial. Flow was similar to the control, with aggregates. A small amount of powder remained stuck at the bottom of the vial which could not be removed with tapping.

[0518] • SSF - 25°C / 60%RH - The composition appeared uniform and had settled. This settling broke into two layers leaving behind a small amount of powder stuck in the edges at the bottom. This was detachable with forceful tapping. The flow was comparable to the control.

[0519] • SSF - 40°C / 75%RH - The composition appeared uniform and had caked. This settling broke into two layers following tapping, leaving behind a fine residue on the walls. A small amount of powder was stuck at the bottom of the vial, the majority of which could be detached with tapping.

[0520] • Mg Stearate - 25°C / 60%RH - The composition appeared uniform or minimally layered. The powder broke as a whole leaving behind a minor amount of powder stuck in the edges at the bottom. This was easily detached with tapping. The powder flowed well but left behind a fine powder residue on the walls.

[0521] • Mg Stearate - 40°C / 75%RH - The composition appeared uniform or minimally layered. The powder had caked but broke after a tap of the vial. The powder thereafter flowed well but with small aggregates, leaving behind a fine powder residue. Powder remained stuck at the bottom of the vial which could not be removed with tapping.

[0522] Following storage for 5 weeks, the various samples (of psilocin benzoate and tartrate) were once again analyzed visually and ranked, as shown in the Table below, based on the observed characteristics.

[0523] Example A3. Further Dry Blend Compositions of Psilocin Further dry blend compositions were made, one loaded with the benzoate salt of psilocin and one with the tartrate salt of psilocin. All compositions were comprised of 25% of the respective psilocin salt. Two were compositions comprising internally blended anti-caking agents (I) whilst one was with an externally blended anti-caking agent (E).

[0524] In the case of internally blended anti-caking agents, all powders were weighed out on an analytical balance and transferred to 7 mL scintillation vials. They were then mixed using a Turbula blender at 32 rpm for 10 min.

[0525] In the case of externally blended anti-caking agent, the same procedure was followed, except the anticaking agent percentage was not included in the initial % formula, since it is treated as separate. The blends were firstly mixed in bulk for 5 min at 32 rpm followed by a second mixing after adding the weighed kaolin for another 5 min.

[0526] Example A4. Further Stability testing of Dry Blend Compositions of Psilocin

[0527] Following visual observations and photos at T=0, one of each of the vials of Example A3 were put on storage at 25°C / 60%RH and one of each at 40°C / 75%RH.

[0528] Following storage for 4 weeks, the vials were visually observed and the Table of Example A2 has been updated based on the results, which is shown below:

[0529] Surprisingly, as shown in the Tables and Examples above, it was discovered that the optimal anti-caking excipient differed between the two different salts of psilocin investigated. The optimal anti-caking excipient for psilocin benzoate was found to be magnesium stearate whilst for psilocin tartrate it was sodium stearyl fumarate. This was surprising, as both magnesium stearate and sodium stearyl fumarate belong to the same general class of excipients, that of the lubricants.

[0530] There is therefore provided herein pharmaceutical compositions comprising psilocin benzoate and magnesium stearate. There is also, therefore, provided herein pharmaceutical compositions comprising psilocin tartrate and sodium stearyl fumarate.

[0531] Whilst magnesium stearate appeared to be the optimal anti-caking excipient for psilocin benzoate, it should be noted that kaolin was the 2nd ranked choice and there is therefore provided herein pharmaceutical compositions comprising psilocin benzoate and kaolin, and uses thereof.

[0532] Whilst magnesium stearate appeared to be the optimal anti-caking excipient for psilocin benzoate, it should be noted that microcrystalline cellulose was the 3rd ranked choice and there is therefore provided herein pharmaceutical compositions comprising psilocin benzoate and microcrystalline cellulose, and uses thereof.

[0533] Whilst sodium stearyl fumarate appeared to be the optimal anti-caking excipient for psilocin tartrate, it should be noted that mannitol was the 2nd ranked choice and there is therefore provided herein pharmaceutical compositions comprising psilocin tartrate and mannitol, and uses thereof.

[0534] Whilst sodium stearyl fumarate appeared to be the optimal anti-caking excipient for psilocin tartrate, it should be noted that microcrystalline cellulose was the 3rd ranked choice and there is therefore provided herein pharmaceutical compositions comprising psilocin tartrate and microcrystalline cellulose, and uses thereof.

[0535] It was surprising that microcrystalline cellulose should be the 3rd ranked choice of anti-caking agent for both the benzoate and tartrate salts of psilocin, in light of the wide variability of the other agents tested.

[0536] There is therefore provided herein pharmaceutical compositions comprising a psilocin, or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose, and uses thereof. It will be appreciated that an embodiment herein referring to a pharmaceutical composition, or use thereof, of psilocin benzoate and magnesium stearate or psilocin tartrate and sodium stearyl fumarate, should be understood to be a disclosure of psilocin benzoate or psilocin tartrate and microcrystalline cellulose.

[0537] It will be appreciated that different salts of psilocin will have different formula weights and any reference herein to a specific mass (mg) of a psilocin salt refers to the mass of that specific psilocin salt required to provide that specific mass (mg) of psilocin freebase when administered. For example, psilocin freebase has a weight of 204.27 g / mol, whilst psilocin benzoate has a weight of 326.38 g / mol. A pharmaceutical composition comprising about 4 mg of psilocin benzoate should be understood to refer to a pharmaceutical composition comprising about 6.39 mg psilocin benzoate, the amount of psilocin benzoate equivalent to 4 mg psilocin freebase.

[0538] Example A5. Nasal Delivery Devices

[0539] In an embodiment, there is provided a nasal delivery device for delivering a pharmaceutical composition as described herein to an olfactory region of a nasal cavity, the device comprising a pharmaceutical composition as described herein.

[0540] In an embodiment, the device is an active nasal delivery device wherein a plunger style actuator, or similar, is depressed to administer a dose. In an embodiment, the nasal delivery device is not a breath actuated delivery device. In an embodiment, the device comprises a dose volume up to 140 mm3.

[0541] In an embodiment, the nasal delivery device may be as described in any one of WO21005308; WO22123128; WO22171969; and W022208014 (the contents of which are incorporated by reference).

[0542] In an embodiment, there is provided a dispenser device, optionally for dispensing a pharmaceutical composition as described herein, the dispenser device comprising: a pharmaceutical composition as described herein; a dispenser outlet; an air expeller for generating a flow of air while the device is being actuated, said air expeller including a piston that slides in an air chamber between a rest position and a dispensing position, said air chamber including a cylindrical body in which said piston slides in airtight manner; and at least one reservoir that contains a single dose of composition, said reservoir including an air inlet that is connected to said air expeller, and a composition outlet that is connected to said dispenser outlet, said air inlet including a composition retainer member for retaining the composition in the reservoir until the composition is dispensed, and said composition outlet being closed by a closure element that is force fitted in the composition outlet of the reservoir; said device further including a mechanical opening system that co-operates with said closure element so as to expel it mechanically from its closed position while the device is being actuated, said mechanical opening system comprising a rod assembly, a first rod portion being part of said air expeller and sliding in said air chamber during actuation of the device, and a second rod portion pushed by said first rod portion during actuation of the device, said rod assembly cooperating at the end of the actuation stroke with said closure element to expel it mechanically from its closed portion, said piston of said air expeller, when in its rest position, co-operating in non-airtight manner with said air chamber, in such a manner that said air chamber is in communication with the atmosphere in the rest position, said piston including an inner lip that slides in airtight manner on said cylindrical surface during actuation of the device, and that co-operates in non-airtight manner with fluting formed on said cylindrical surface in the rest position to put the air chamber in communication with the atmosphere in the rest position, said piston co-operating in airtight manner with said cylindrical body in any positions, and cooperating in non-airtight manner with said cylindrical surface only in the rest position.

[0543] In an embodiment, there is provided a dispenser device, optionally for dispensing a pharmaceutical composition as described herein, the dispenser device comprising: a pharmaceutical composition as described herein; a dispenser outlet; an air expeller for generating a flow of air while the device is being actuated, said air expeller including a piston that slides in an air chamber between a rest position and a dispensing position, said air chamber including a cylindrical body in which said piston slides in airtight manner; and at least one reservoir that contains a single dose of composition, said reservoir including an air inlet that is connected to said air expeller, and a composition outlet that is connected to said dispenser outlet, said air inlet including a composition retainer member for retaining the composition in the reservoir until the composition is dispensed, and said composition outlet being closed by a closure element that is force fitted in the composition outlet of the reservoir; said device further including a mechanical opening system that co-operates with said closure element so as to expel said closure element mechanically from a closed position while the device is being actuated, said piston of said air expeller, when in the rest position, co-operating in non-airtight manner with said air chamber, in such a manner that said air chamber is in communication with the atmosphere in the rest position, wherein said piston includes an inner lip configured to cooperate with a cylindrical surface of a cylindrical member extending inside the cylindrical body, said cylindrical surface including fluting that co-operates in non-airtight manner with said inner lip of the piston in the rest position.

[0544] In an embodiment, said piston comprises one or more markings which are visible only when the piston is in the rest position and not visible when the piston is in the dispensing position. In an embodiment, a method comprising the use of the dispenser device comprises the actuation of the piston from the rest position to the dispensing position such that the one or more markings are no longer visible. In an embodiment, successful actuation of the dispensing device occurs when the one or more markings are no longer visible. In an embodiment, the one or more markings may be: one or more coloured lines, one or more coloured shapes, one or more words or written text or one or more physical features.

[0545] In an embodiment, there is provided an active nasal delivery device as described herein comprising one or more markings, said markings being visible when the active nasal delivery device is in the resting state and not visible following successful actuation of said active nasal delivery device. In an embodiment, the absence from view of said markings represents successful actuation of the active nasal delivery device. In an embodiment, the one or more markings may be as described herein.

[0546] In an embodiment, there is provided a method of intranasally delivering a powder pharmaceutical formulation comprising a psychedelic and one or more pharmaceutically acceptable carriers or excipients, to a patient, wherein 30% or more, 40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 91 % or more, 92% or more, 93% or more, 94% or more, 95% or more, 96% or more, 97% or more, 98% or more or 99% or more of the formulation reaches the turbinates and olfactory region, wherein the psychedelic is psilocin, or a pharmaceutically acceptable salt thereof, and the formulation is delivered via a nasal powder dispenser device which may comprise one or more of: a nasal dispenser head for inserting into a patient's nostril, the nasal dispenser head including a dispenser orifice; and an air expeller that, during actuation of the nasal powder dispenser device, generates a flow of compressed air so as to dispense a dose of the powder pharmaceutical formulation into the nostril through the dispenser orifice.

[0547] Example A6. Crystalline psilocin salts

[0548] To identify psilocin salts with improved properties, a salt screen was performed with 24 different counterions and 3 different solvent systems. Crystalline material with a novel XRPD pattern was isolated from experiments with 13 of the counterions and their properties assessed. Following identification of preferred salts with optimal properties, polymorph screening of these salts was conducted.

[0549] The results are disclosed in US11312684 and US20240124398A1 , the content of each of which is incorporated herein by reference in their entirety.

[0550] In an embodiment, the pharmaceutical composition comprises a crystalline psilocin salt as characterized by one or more peaks in the Table below:

[0551] Example B1. Spray Dried Formulations of Psilocin

[0552] Spray drying typically involves injecting a liquid composition of material into a chamber for contact with a drying fluid which is concurrently flowed through the chamber. The injected wet material in the form of droplets contacts the stream of drying fluid so that the liquid passes from the droplets to the drying fluid stream, producing a spray dried product that is discharged from the drying chamber, and drying fluid effluent that likewise is discharged from the drying chamber. Spray dried dry powder formulations of psilocin (T2, T3 and T4) were prepared as described below.

[0553] Feed stocks were prepared by making up separate polymer in water and psilocin salt in solvent solutions. The two were then mixed by slowly pouring the solution of the active into the polymer while continuing to stir.

[0554] Preparation of T2 T2 is a spray dried powder formulation of 50% psilocin (as the benzoate salt) and 50% HPMC 606 (Pharmacoat). Feed stocks were prepared by making a polymer in water solution and a psilocin benzoate (the active) in solvent solution. The two solutions were then mixed by slowly pouring the solution of the active into the polymer solution, while continuing to stir.

[0555] The following spray drying parameters were used:

[0556] The product was a white amorphous powder.

[0557] Preparation of T3

[0558] T3 is a spray dried powder formulation of 25% psilocin (as the tartrate salt), 62.5% HPMC 606 (Pharmacoat) and 12.5% methylcellulose (SM-100). Feed stocks were prepared by making a polymer in water solution and a psilocin tartrate (the active) in solvent solution. The active solution was filtered using 25mm diameter, 0.22 pm pore size Nylon filters. The two solutions were then mixed by slowly pouring the solution of the active into the polymer solution, while continuing to stir.

[0559] The following spray drying parameters were used:

[0560] The product was a white amorphous powder.

[0561] Preparation of T4

[0562] T4 is a spray dried powder formulation of 25% psilocin (as the benzoate salt), 62.5% HPMC (Pharmacoat 606) and 12.5% methylcellulose (SM-100). Feed stocks were prepared by making a polymer in water solution and a psilocin benzoate (the active) in solvent solution. The two solutions were then mixed by slowly pouring the solution of the active into the polymer solution, while continuing to stir.

[0563] The product was a white amorphous powder.

[0564] Example B2. A Study to Investigate the Pharmacokinetics of Psilocin Following a Single Intravenous Infusion, Subcutaneous and Intranasal Administration of Psilocin to Male Beagle Dogs The purpose of this study was to investigate the pharmacokinetics of psilocin following a single intravenous infusion, subcutaneous injection and intranasal administration of psilocin to male beagle dogs. Beagle dogs are frequently used in such investigations and such use is accepted by regulatory authorities.

[0565] One group of four dogs was dosed as follows:

[0566] *= applicator used with minimum fill weight of 3mg active pharmaceutical ingredient (API).

[0567] +=administered as a 10 minute infusion

[0568] The intravenous and subcutaneous doses comprise 30% w / v mannitol (D-Mannitol), 2.6% (w / v) citric acid monohydrate and 3.7% w / v sodium citrate dihydrate in saline.

[0569] Following dosing, serial whole blood samples (ca. 0.80mL) were collected into individual containers. The whole blood samples were placed into a cooling block before being centrifuged at 3000g, 10 minutes at ca.4°C and the resultant plasma drawn off.

[0570] All scientific procedures on living animals conducted in the United Kingdom (UK) are subject to legislation under the Animals (Scientific Procedures) Act 1986 (referred to subsequently as 'the Act' and amended by the ASPA Regulations 2012). The Act conforms to the European Directive 2010 / 63 / EU and to the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS123) Strasbourg, Council of Europe. The Act is administered by the UK Home Office and provides for establishment designation, issue of project licenses for specified programmes of work and issue of personal licenses for individuals conducting procedures. The study was conducted in accordance with the Act, with UK Home Office Guidance on the implementation of the Act and with all applicable Codes of Practice for the care and housing of laboratory animals. The test items were as follows:

[0571] The intravenous dose apparatus consisted of a calibrated KDS infusion pump, infusion line, 21 G cannula and 21 G needle. Prior to dose administration, the cephalic vein was cannulated with a 21 G cannula to facilitate dose administration. The dose was administered directly to the cannula over a 10 minute period.

[0572] The subcutaneous dose apparatus consisted of an appropriate sized syringe and 21 G needle. The dose was administered into the nape of the neck as a single bolus. For both the intravenous and subcutaneous doses, an appropriate volume of dose formulation, including an excess, was taken up into the dose apparatus. Following this, any trapped air was expelled and the syringe was primed with the exact volume to be administered. The apparatus was then measured to determine the pre dose weight followed by administration of the dose. The empty dose apparatus was then measured post dose to calculate the exact amount per kg body weight that each dog received.

[0573] The intranasal doses were administered as a single administration to one nostril (per dog). Each intranasal delivery device was gently shaken and tapped prior to actuation, with no priming required. The dogs were restrained manually, with the dog appropriately restrained and the head held such that the nose was tipped up slightly above the horizontal plane. The sprayer tip of the device was then inserted inside the appropriate nostril (approximately 5mm) followed by a single actuation of the device to deliver a fixed dose of the test item. The pump was pressed firmly once to deliver the test item and special care was taken to ensure the tip of the device was not pulled out of the nostril whilst the pump was pressed. Dogs were observed closely during and after the administration. The difference between device weight prior and post administration was used to calculate the exact amount per kg body weight that each dog received.

[0574] Each intranasal delivery device comprised sufficient formulation such that 2.5mg freebase equivalent of psilocin was administered.

[0575] The animal specifications were as follows: The housing and husbandry conditions were in line with those usually used for a study of this nature, of which the skilled person will be aware.

[0576] Plasma pharmacokinetic parameters were derived by non-compartmental analysis (linear / logarithmic trapezoidal) using WinNonlin (Version 8.2) software. Three PK profiles (one per analyte) will be generated per animal per group; 36 profiles will be generated in total for the initial phase. The following parameters will be determined from the plasma concentration-time profile, if appropriate and sufficient data is available. Plasma concentrations below the limit of quantification of the assay, reported as BLQ, will be taken as zero before Cmax and omitted after Cmax.

[0577] The terminal half-life was calculated from a minimum of 3 data points, with a correlation coefficient greater than 0.8. In addition, the data points used in the calculation should cover a time period of a minimum period equal to that of the half-life. Where an estimate of the half- life could not be determined, the value n.d will be entered. If the terminal phase cannot be described then all other predicted parameters will also be given the value of n.d.

[0578] *for extravascular models, the fraction of dose absorbed (F) cannot be estimated, therefore, Volume of distribution and Clearance for these models are actually Volume / F and Clearance / F (where F=fraction of dose absorbed).

[0579] The Table below summarizes various pharmacokinetic results of the study:

[0580] Fig. 1 shows the mean psilocin plasma concentration (ng / mL) against time for each of the test items. Fig. 2 shows the mean psilocin plasma concentration (ng / mL) against time for each of T2, T3 and T4.

[0581] From the data, it can be seen that the intranasal formulations comprising methylcellulose (T3 and T4) displayed a much lower Tmax compared with the intranasal formulation without methylcellulose (3.7 and 4.5 vs. 20.0).

[0582] The length of a mystical / psychedelic experience is an important factor when considering the cost of any psychedelic treatment. Psilocybin, for example, (of which psilocin is the active metabolite) when taken orally may lead to a mystical / psychedelic experience lasting 6-8 hours. The patient must be supervised in the inpatient setting for the entirety of this length of time, leading to high potential treatment costs and reducing patient access.

[0583] The person skilled in the art will appreciate that the intranasal psilocin formulations provided herein all represent an improvement over an oral administration of psilocybin. Surprisingly, however, those intranasal formulations which comprise methylcellulose outperformed the intranasal formulation which did not comprise methylcellulose. Additionally, it can be seen that the methylcellulose formulations achieved a higher Cmax than those without (177.3 and 210.0 vs. 82.1).

[0584] It will be appreciated that different salts of psilocin will have different formula weights and any reference herein to a specific mass (mg) of a psilocin salt refers to the mass of that specific psilocin salt required to provide that specific mass (mg) of psilocin freebase when administered. For example, psilocin freebase has a weight of 204.27 g / mol, whilst psilocin benzoate has a weight of 326.38 g / mol. A pharmaceutical composition comprising about 4 mg of psilocin benzoate should be understood to refer to a pharmaceutical composition comprising about 6.39 mg psilocin benzoate, the amount of psilocin benzoate equivalent to 4 mg psilocin freebase.

[0585] Example C1. Dry Blend Formulations of Psilocin

[0586] Examples B1 and B2 describe spray dried dry powder formulations of psilocin. Spray drying equipment requires a significant amount of initial investment as well as sizable investment in ongoing maintenance. The nozzles of a spray dryer are prone to becoming clogged and rotary disk atomisers can become corroded over time. It would therefore be desirable if the properties displayed by the spray dried formulations of Examples B1 and B2 could be obtained from dry blended formulations of psilocin. Dry blending is a simpler, more cost-effective method of producing dry powders.

[0587] Formulations of psilocin as described in Examples B1 and B2 were produced by dry blending and their properties characterised. It was seen that it was possible to achieve substantially similar dissolution profiles with the dry blend formulations, as compared to the equivalent spray dried dispersions.

[0588] The particles of a dry blend are not intimately mixed with each other on the molecular level as they would be in a spray dried dispersion. It would not, therefore, be expected that dry blend formulations would exhibit equivalent dissolution characteristics.

[0589] Dry blend formulations of the benzoate and tartrate salt of psilocin were prepared at 10g batch (25% w / w psilocin salt, 62.5% w / w HPMC 606 and 12.5% w / w MC SM-100) as follows:

[0590] 6.25 g of HPMC 606 were weighed out on an analytical balance and transferred to a 60 mL amber glass jar.

[0591] 1 .25 g of MC SM-100 were weighed out on an analytical balance and transferred to the same jar.

[0592] 2.5 g of psilocin BEN or TAR as appropriate were weighed out on an analytical balance and transferred to the polymers (TAR was found to form aggregates so it was gently hand milled using pestle and mortar prior to weighing).

[0593] This was then sealed with parafilm and put on a Turbula blender for 10 min at 32 rpm.

[0594] The formulations were then stored at 25°C / 60%RH or 40°C / 75%RH.

[0595] Example C2. Dissolution Testing

[0596] Dissolution testing in solid form drugs measures how quickly and how much of a drug dissolves in a liquid medium. This is crucial because a drug must dissolve before it can be absorbed into the bloodstream and have a therapeutic effect. Dissolution testing ensures consistent drug release, helps predict bioavailability and is essential for quality control.

[0597] The dissolution rate of the dry powder formulations were determined using a method comprising the use of a UV- fibre optic-based dissolution apparatus (one such suitable device is the Rainbow® Dynamic Dissolution Monitor by Pion Inc) and simulated nasal fluid. The simulated nasal fluid comprises 8.76g / L NaCI, 3.00g / L KCI, 0.584g / L CaCh and deionised water.

[0598] The dissolution apparatus was set up with a 2mm probe to measure the dissolution rate. 40mg of the dry powder formulation (10mg API as its salt form) was transferred into 10mL of simulated nasal fluid, heated to a constant temperature of 37°C and stirred at 150 RPM using a crossed stirrer bar. Measurements were taken at 3s intervals for 130 intervals followed by 60 measurements taken at 10s intervals for a total time of 16 minutes and 30s. Detection of dissolution is by UV absorbance.

[0599] Dissolution profiles were assessed at T=0, T=1 month, T=3 months and T=6 months for each of the following samples:

[0600] • Psilocin BEN DB (benzoate salt dry blended) stored at 25°C / 60%RH (Table C 1 )

[0601] • Psilocin BEN DB (benzoate salt dry blended) stored at 40°C / 75%RH (Table C2)

[0602] • Psilocin BEN SDD (benzoate salt spray dried) stored at 25°C / 60%RH (Table C3)

[0603] • Psilocin BEN SDD (benzoate salt spray dried) stored at 40°C / 75%RH (Table C4)

[0604] • Psilocin TAR DB (tartrate salt dry blended) stored at 25°C / 60%RH (Table C5)

[0605] • Psilocin TAR DB (tartrate salt dry blended) stored at 40°C / 75%RH (Table C6) • Psilocin TAR SDD (tartrate salt spray dried) stored at 25°C / 60%RH (Table C7)

[0606] • Psilocin TAR SDD (tartrate salt spray dried) stored at 40°C / 75%RH (Table C8)

[0607] Results of dissolution testing are displayed in tables C1 to C8 below and in Figures 3 to 7.

[0608] The data show that the dissolution profiles present between spray dried formulations and dry blend formulations are substantially similar at a range of timepoints following storage at 25°C / 60%RH and 40°C / 75%RH. In the Tables below and in Figures 3 to 7, the value for “Time” is minutes. Table C1 - Psilocin BEN DB (benzoate salt dry blended) stored at 25°C / 60%RH

[0609] Table C2 - Psilocin BEN DB (benzoate salt dry blended) stored at 40°C / 75%RH

[0610]

[0611] Table C3 - Psilocin BEN SDD (benzoate salt spray dried) stored at 25°C / 60%RH

[0612] Table C4 - Psilocin BEN SDD (benzoate salt spray dried) stored at 40°C / 75%RH

[0613]

[0614] Table C5 - Psilocin TAR DB (tartrate salt dry blended) stored at 25°C / 60%RH

[0615] Table C6 - Psilocin TAR DB (tartrate salt dry blended) stored at 40°C / 75%RH

[0616] Table C7 - Psilocin TAR SDD (tartrate salt spray dried) stored at 25°C / 60%RH Table C8 - Psilocin TAR SDD (tartrate salt spray dried) stored at 40°C / 75%RH

[0617] OTHER EMBODIMENTS

[0618] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each independent publication or patent application was specifically and individually indicated to be incorporated by reference.

[0619] While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure that come within known or customary practice within the art to which the invention pertains and may be applied to the essential features hereinbefore set forth, and follows in the scope of the claims.

[0620] Other embodiments are within the claims.

Claims

CLAIMS1 . A pharmaceutical composition comprising a pharmaceutically acceptable salt of psilocin and one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is a dry blended dry powder composition.

2. The pharmaceutical composition according to claim 1 , wherein the psilocin salt is psilocin benzoate.

3. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin benzoate.

4. The pharmaceutical composition according to claim 1 , wherein the psilocin salt is psilocin tartrate.

5. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin tartrate.

6. The pharmaceutical composition according to any one of claims 1 to 5, comprising a cellulose- based excipient.

7. The pharmaceutical composition according to claim 6, wherein the cellulose-based excipient is methyl cellulose or hydroxypropyl methyl cellulose (HPMC).

8. The pharmaceutical composition according to any one of claims 1 to 5, comprising methyl cellulose and hydroxypropyl methyl cellulose (HPMC).

9. The method of any one preceding claim, wherein the pharmaceutical composition comprises about 1 mg to about 10 mg of psilocin freebase or about 1 mg to about 10 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

10. The method of any one preceding claim, wherein the pharmaceutical composition comprises about 1 mg to about 8 mg of psilocin freebase or about 1 mg to about 8 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.11 . The method of any one preceding claim, wherein the pharmaceutical composition comprises about1 mg to about 6 mg of psilocin freebase or about 1 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

12. The method of any one preceding claim, wherein the pharmaceutical composition comprises about2 mg to about 6 mg of psilocin freebase or about 2 mg to about 6 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

13. The method of any one preceding claim, wherein the pharmaceutical composition comprises about 2 mg to about 4 mg of psilocin freebase or about 2 mg to about 4 mg psilocin freebase equivalent of a pharmaceutically acceptable salt of psilocin.

14. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin salt.

15. The pharmaceutical composition according to claim 1 , comprising 12.5% w / w methyl cellulose.

16. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin salt and 12.5% w / w methyl cellulose.

17. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin benzoate and 12.5% w / w methyl cellulose.

18. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin tartrate and 12.5% w / w methyl cellulose.

19. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin salt, 62.5% w / w HPMC and 12.5% w / w methyl cellulose.

20. The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin benzoate, 62.5% w / w HPMC and 12.5% w / w methyl cellulose.21 . The pharmaceutical composition according to claim 1 , comprising 25% w / w psilocin tartrate, 62.5% w / w HPMC and 12.5% w / w methyl cellulose.

22. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim.

23. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the composition is administered:Intransally;Via inhalation;Intravenously;Intramuscularly; orSubcutaneously.

24. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the composition is administered intranasally.

25. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the disease or condition is selected from one or more of:major depressive disorder (MDD), moderate to severe MDD, treatment-resistant MDD, major depression, melancholic depression, atypical depression, dysthymia, anxiety, treatment-resistant anxiety, end of life anxiety, generalised anxiety disorder, panic disorder, social anxiety, post-traumatic stress disorder, acute stress disorder, obsessive compulsive disorder, social phobia, substance abuse, alcoholism, tobacco abuse, drug abuse, anorexia nervosa, bulimia nervosa, binge eating disorder, primary impulse-control disorders, and obsessive-compulsive disorder.

26. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition without concomitant treatment with one or more further active agents, optionally without concomitant treatment with one or more further active agents selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound; optionally wherein the subject discontinues treatment with the one or more further active agents prior to undergoing treatment with the pharmaceutical composition.

27. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents.

28. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: a selective serotonin reuptake inhibitor (SSRI), a serotonin and norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA) or any other antidepressant compound.

29. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex), Fluoxetine (Prozac, Sarafem), Fluvoxamine (Luvox, Faverin), Paroxetine (Paxil, Seroxat), Sertraline (Zoloft, Lustral), Desvenlafaxine (Pristiq), Duloxetine (Cymbalta), Levomilnacipran (Fetzima), Milnacipran (Ixel, Savella), Venlafaxine (Effexor), Vilazodone (Viibryd), Vortioxetine (Trintellix), Nefazodone (Dutonin, Nefadar, Serzone), Trazodone (Desyrel), Reboxetine (Edronax), Teniloxazine (Lucelan, Metatone), Viloxazine (Vivalan), Bupropion (Wellbutrin), Amitriptyline (Elavil, Endep), Amitriptylinoxide (Amioxid, Ambivalon, Equilibria), Clomipramine (Anafranil), Desipramine (Norpramin, Pertofrane), Dibenzepin (Noveril, Victoril), Dimetacrine (Istonil), Dosulepin (Prothiaden), Doxepin (Adapin, Sinequan), Imipramine(Tofranil), Lofepramine (Lomont, Gamanil), Melitracen (Dixeran, Melixeran, Trausabun), Nitroxazepine (Sintamil), Nortriptyline (Pamelor, Aventyl), Noxiptiline (Agedal, Elronon, Nogedal), Opipramol (Insidon), Pipofezine (Azafen / Azaphen), Protriptyline (Vivactil), Trimipramine (Surmontil), Amoxapine (Asendin), Maprotiline (Ludiomil), Mianserin (Tolvon), Mirtazapine (Remeron), Setiptiline (Tecipul), Isocarboxazid (Marplan), Phenelzine (Nardil), Tranylcypromine (Parnate), Selegiline (Eldepryl, Zelapar, Emsam), Caroxazone (Surodil, Timostenil), Metralindole (Inkazan), Moclobemide (Aurorix, Manerix), Pirlindole (Pirazidol), Toloxatone (Humoryl), Agomelatine (Valdoxan), Esketamine (Spravato), Ketamine (Ketalar), Tandospirone (Sediel), Tianeptine (Stabion, Coaxil), Amisulpride (Solian), Aripiprazole (Ability), Brexpiprazole (Rexulti), Lurasidone (Latuda), Olanzapine (Zyprexa), Quetiapine (Seroquel), Risperidone (Risperdal), Trifluoperazine (Stelazine), Buspirone (Buspar), Lithium (Eskalith, Lithobid), Modafinil (Provigil), Thyroxine (T4) and / or Triiodothyronine (T3).

30. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are one or more SSRIs.

31. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method comprises the administration of the pharmaceutical composition alongside one or more further active agents, wherein the one or more further active agents are selected from: citalopram, escitalopram, sertraline, fluoxetine, paroxetine or vilazodone.

32. The pharmaceutical composition for use of claim 31 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of citalopram.

33. The pharmaceutical composition for use of claim 31 , wherein the one or more further active agents is 10 or 20 mg once daily of escitalopram.

34. The pharmaceutical composition for use of claim 31 , wherein the one or more further active agents is 50, 100, 150 or 200 mg once daily of sertraline.

35. The pharmaceutical composition for use of claim 31 , wherein the one or more further active agents is 10, 20, 30, 40, 50 or 60 mg once daily of fluoxetine.

36. The pharmaceutical composition for use of claim 31 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of paroxetine.

37. The pharmaceutical composition for use of claim 31 , wherein the one or more further active agents is 10, 20, 30 or 40 mg once daily of vilazodone.

38. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment comprises the provision of psychological support to the patient.

39. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment comprises the provision of psychological support to the patient prior to administration of the pharmaceutical composition.

40. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment comprises the provision of psychological support to the patient following administration of the pharmaceutical composition.

41. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment is a method of treatment of moderate to severe major depressive disorder (MDD).

42. The pharmaceutical composition of any one preceding claim for use in a method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject the composition of any one preceding claim, wherein the method of treatment is a method of treatment of a patient who is diagnosed with major depressive disorder, or moderate to severe major depressive disorder (MDD), by a licensed professional in accordance with accepted medical practice.

43. A method of preparing a dry powder pharmaceutical composition comprising a pharmaceutically acceptable salt of psilocin and one or more pharmaceutically acceptable carriers or excipients, wherein said method comprises a dry blending step.

44. The method according to claim 43, wherein the psilocin salt is psilocin benzoate.

45. The method according to claim 43, wherein the psilocin salt is psilocin tartrate.

46. A pharmaceutical composition comprising psilocin benzoate and magnesium stearate.

47. A pharmaceutical composition comprising psilocin tartrate and sodium stearyl fumarate.

48. A pharmaceutical composition comprising psilocin, or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose.

49. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin, or a pharmaceutical acceptable salt thereof, and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises a cellulose-based excipient having a viscosity of 60-140 mPa«s.

50. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: psilocin, or a pharmaceutical acceptable salt thereof, and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

51. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin tartrate and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

52. A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (i) psilocin benzoate and (ii) one or more pharmaceutically acceptable carriers or excipients, wherein the pharmaceutical composition is administered to the nasal cavity and wherein the pharmaceutical composition comprises: a cellulose-based excipient having a viscosity of 60-140 mPa«s; and a cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s; wherein the cellulose-based excipient having a viscosity of 60-140 mPa«s is methylcellulose and the pharmaceutical composition comprises about 12.5% w / w methylcellulose and wherein the cellulose-based excipient having a viscosity of less than 60, 50, 40, 30, 20 or 10 mPa«s is HPMC and the pharmaceutical composition comprises about 62.5% w / w HPMC.

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