In addition, such administration also encompasses use of each type of therapeutic agent in a sequential manner. 10. [0166] In certain embodiments, the topical administration is intranasal. TGA was conducted with 60 mL/min N [0380] In situ salt formation screening was performed by the method of Tong & Whitesell (Tong W-Q and Whitesell G Pharmaceutical Development and Technology, 1998, 3:215-223. Examples of alkyl groups include methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, tert- butyl, pentyl, iso-amyl, hexyl, octyl, noyl and the like. [0327] Preferred unit dosage formulations are those containing an effective dose, as herein below recited, or an appropriate fraction thereof, of the active ingredient. orally, topically, or by injection. [096] In certain embodiments, the compound is N-methyl-l-(5-(thiophen-2- yl)tetrazolo[l,5-a]pyrazin-8-yl)azetidin-3-amine, or a salt, hydrate, or polymorph thereof. etidin- 3 -amine, or a salt, polymorph or hydrate thereof. Appropriate gelling agents can include, but are not limited to, semisynthetic cellulose derivatives (such as hydroxypropylmethylcellulose) and synthetic polymers, galactomannan polymers (such as guar and derivatives thereof) and cosmetic agents. The present invention includes all cis, trans, syn, anti, entgegen (E), and zusammen (Z) isomers as well as the appropriate mixtures thereof.
Additionally, the compounds disclosed herein can exist in unsolvated as well as solvated forms with pharmaceutically acceptable solvents such as water, ethanol, and the like. [0465] Compound 2 (500mg, 1.74 mmol) was added to 15 mL of acetonitrile. 2016 Nov 24;12:1777-1781. doi: 10.2147/TCRM.S124148. [0328] It should be understood that in addition to the ingredients particularly mentioned above, the formulations described above may include other agents conventional in the art having regard to the type of formulation in question, for example those suitable for oral or intranasal administration may include flavoring agents. In certain embodiments, the polymorph comprises at least 80% N-methyl-l-(5-(thiophen-2-yl)tetrazolo[l,5-a]pyrazin-8-yl)az
Also provided herein is a combination therapy comprising Compound 2 Mesylate Form 1 and chlorpheniramine. The data are consistent with the thermal analysis and indicate that Compound 1, Tartrate Salt Form 2 is a stable, non-hydroscopic monohydrate. etidin-3- amine (Compound 2, 5.0 g, 17.40 mmol) was added methanol (150mL) and the slurry was stirred at room temperature. [0226] The term "haloalkyl," as used herein, alone or in combination, refers to an alkyl group having the meaning as defined above wherein one or more hydrogens are replaced with a halogen. [0293] The term "solubility" is generally intended to be synonymous with the term "aqueous solubility," and refers to the ability, and the degree of the ability, of a compound to dissolve in water or an aqueous solvent or buffer, as might be found under physiological conditions. 2017 Nov 1;15:19. doi: 10.1186/s12948-017-0074-3. These formulations generally have an osmolality in the range of 220-320 mOsm/kg, and preferably have an osmolality in the range of 235-300 mOsm/kg. The salt as recited in Claim 10, wherein Z is chosen from a stoichiometric hydrate and a nonstoichiometric hydrate, or a polymorph thereof. An example, without limitation, of a prodrug would be a compound which is administered as an ester (the "prodrug"), but then is metabolically hydrolyzed to the carboxylic acid, the active entity. The use of N-methyl-l-(5-(thiophen-2-yl)tetrazolo[l,5-a]pyrazin-8-yl)azetidin- 3 -amine hydrochloride, or a polymorph thereof, in the manufacture of a medicament for topical intranasal delivery.
In other embodiments, it may comprise from 0.1% to 2% w/w of the formulation. [038] Figure 22: DSC/TGA Analysis of N-methyl-l-(5-(thiophen-2- yl)tetrazolo[l,5-a]pyrazin-8-yl)azetidin-3-amine Citrate Form 1, also known as Compound 2 Citrate Salt Form 1.
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