Salts and solid forms of muscarinic receptor agonists

Abstract

Disclosed herein are salts and solid forms of Compound (I), and methods of preparing and using the same. In some aspects, the solid form is a crystalline form of the HCl salt. Also disclosed herein are methods of treating neurological disorders and diseases using the disclosed salts and solid forms.

Description

SALTS AND SOLID FORMS OF MUSCARINIC RECEPTOR AGONISTS CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application 63 / 700,218, filed on September 27, 2024, the contents of which is hereby incorporated in its entirety. BACKGROUND

[0002] Neurological disorders are now the leading source of disability in the world. Parkinson’s disease (PD) is a progressive neurodegenerative disorder that affects movement. Parkinson’s disease is the most common movement disorder and the fastest growing neurological disorder. In 2016, the global prevalence of Parkinson’s disease was 6,062,893 with 3.2 million disability- adjusted life-years (DALYs) and 211,296 deaths. This is significantly higher than prevalence reported in 1990, when the global PD population was 2.5 million. In the United States in 2017, there were an estimated one million individuals with diagnosed Parkinson’s disease. As the population ages, further substantial increases in PD diagnosis are projected. The projected PD prevalence in the year 2037 in the United States alone will be more than 1.6 million.

[0003] The motor symptoms arising from the loss of striatal dopamine (DA) in PD are routinely treated with levodopa (L-DOPA) treatment. Long-term levodopa therapy results in the development of abnormal involuntary movements called levodopa-induced dyskinesia (LID). Current treatment options for LID are limited and have many side effects. Novel muscarinic receptor agonists as well as novelty salts and solid forms thereof are needed for treating neurological diseases and disorders. SUMMARY

[0004] The present disclosure provides salts and solid forms of 5-((1R,5R)-3- azabicyclo[3.1.0]hexan-1-yl)-3-methyl-1,2,4-oxadiazole (Compound (I)) having the following structural formula:and methods of preparing and methods of using the same.

[0005] In aspects, the present disclosure provides solid forms of a hydrochloric acid salt of Compound (I).

[0006] In aspects, the present disclosure provides solid forms of a tartaric acid salt of Compound (I).

[0007] In aspects, the present disclosure provides 2-napthalenesulfonic acid salt, stearic acid salt, caprylic acid salt, 1-hydroxy-2-napthoic acid salt, decanoic acid salt, oleic acid salt, or benzoic acid salt of Compound (I) and solid forms thereof.

[0008] In aspects, the present disclosure provides hydrobromic acid salt, naphthalene-1,5- disulfonic acid salt, sulfuric acid salt, ethane-1,2-disulfonic acid salt, ethanesulfonic acid salt, 2- hydroxyethanesulfonic acid salt, p-toluenesulfonic acid salt, methanesulfonic acid salt, naphthalene-2-sulfonic acid salt, benzenesulfonic acid salt, maleic acid salt, L-aspartic acid salt, phosphoric acid salt, (+)-camphor-10-sulfonic acid salt, L-glutamic acid salt, malonic acid salt, gentisic acid salt, fumaric acid salt, citric acid salt, D-glucuronic acid salt, glycolic acid salt, L- malic acid salt, hippuric acid salt, L-gluconic acid salt, DL-lactic acid salt, L-ascorbic acid salt, benzoic acid, succinic acid salt, adipic acid salt, or acetic acid salt of Compound (I) and solid forms thereof.

[0009] The present disclosure provides pharmaceutical compositions comprising one or more salts disclosed herein and pharmaceutically acceptable carriers or excipients.

[0010] The present disclosure provides methods of treating a disease or disorder, comprising administering to a subject in need thereof one or more salts disclosed herein, or pharmaceutical compositions comprising one or more salts disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG.1A is the powder X-ray diffractogram (XRPD) of Compound (I) HCl salt Solid Form A.

[0012] FIG. 1B is the differential scanning colorimetry (DSC) of Compound (I) HCl salt Solid Form A.

[0013] FIG.2A is the powder X-ray diffractogram (XRPD) of Compound (I) HCl salt Solid Form B.

[0014] FIG. 2B is the differential scanning colorimetry (DSC) of Compound (I) HCl salt Solid Form B.

[0015] FIG.3A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-L-tartaric acid salt Solid Form A.

[0016] FIG.3B is the differential scanning colorimetry (DSC) of Compound (I) (+)-L-tartaric acid salt Solid Form A.

[0017] FIG.4A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-L-tartaric acid salt Solid Form B.

[0018] FIG.5A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-L-tartaric acid salt Solid Form C.

[0019] FIG.5B is the differential scanning colorimetry (DSC) of Compound (I) (+)-L-tartaric acid salt Solid Form C.

[0020] FIG.6A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-L-tartaric acid salt Solid Form D.

[0021] FIG.6B is the differential scanning colorimetry (DSC) of Compound (I) (+)-L-tartaric acid salt Solid Form D.

[0022] FIG.7A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-L-tartaric acid salt Solid Form E (from temperature cycling in DMA).

[0023] FIG.7B is the differential scanning colorimetry (DSC) of Compound (I) (+)-L-tartaric acid salt Solid Form E.

[0024] FIG.8A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-L-tartaric acid salt Solid Form F / A.

[0025] FIG.8B is the differential scanning colorimetry (DSC) of Compound (I) (+)-L-tartaric acid salt Solid Form F / A.

[0026] FIG.9A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-L-tartaric acid salt Solid Form G.

[0027] FIG. 10A is the powder X-ray diffractogram (XRPD) of Compound (I) HBr salt Solid Form A.

[0028] FIG.10B is the differential scanning colorimetry (DSC) of Compound (I) HBr salt Solid Form A.

[0029] FIG.11A is the powder X-ray diffractogram (XRPD) of Compound (I) naphthalene-1,5- disulfonic acid salt Solid Form A.

[0030] FIG. 11B is the differential scanning colorimetry (DSC) of Compound (I) naphthalene- 1,5-disulfonic acid salt Solid Form A.

[0031] FIG.12A is the powder X-ray diffractogram (XRPD) of Compound (I) naphthalene-1,5- disulfonic acid salt Solid Form B.

[0032] FIG. 12B is the differential scanning colorimetry (DSC) of Compound (I) naphthalene- 1,5-disulfonic acid salt Solid Form B.

[0033] FIG.13A is the powder X-ray diffractogram (XRPD) of Compound (I) naphthalene-1,5- disulfonic acid salt Solid Form C.

[0034] FIG. 13B is the differential scanning colorimetry (DSC) of Compound (I) naphthalene- 1,5-disulfonic acid salt Solid Form C.

[0035] FIG.14A is the powder X-ray diffractogram (XRPD) of Compound (I) naphthalene-1,5- disulfonic acid salt Solid Form D.

[0036] FIG. 14B is the differential scanning colorimetry (DSC) of Compound (I) naphthalene- 1,5-disulfonic acid salt Solid Form D.

[0037] FIG.15A is the powder X-ray diffractogram (XRPD) of Compound (I) sulfonic acid salt Solid Form A.

[0038] FIG. 15B is the differential scanning colorimetry (DSC) of Compound (I) sulfonic acid salt Solid Form A.

[0039] FIG.16A is the powder X-ray diffractogram (XRPD) of Compound (I) sulfonic acid salt Solid Form B.

[0040] FIG. 16B is the differential scanning colorimetry (DSC) of Compound (I) sulfonic acid salt Solid Form B.

[0041] FIG. 17A is the powder X-ray diffractogram (XRPD) of Compound (I) ethane-1,2- disulfonic acid salt Solid Form A.

[0042] FIG. 17B is the differential scanning colorimetry (DSC) of Compound (I) ethane-1,2- disulfonic acid salt Solid Form A.

[0043] FIG.18A is the powder X-ray diffractogram (XRPD) of Compound (I) ethanesulfonic acid salt Solid Form A.

[0044] FIG.18B is the differential scanning colorimetry (DSC) of Compound (I) ethanesulfonic acid salt Solid Form A.

[0045] FIG.19A is the powder X-ray diffractogram (XRPD) of Compound (I) ethanesulfonic acid salt Solid Form B.

[0046] FIG.20A is the powder X-ray diffractogram (XRPD) of Compound (I) ethanesulfonic acid salt Solid Form C.

[0047] FIG.20B is the differential scanning colorimetry (DSC) of Compound (I) ethanesulfonic acid salt Solid Form C.

[0048] FIG. 21A is the powder X-ray diffractogram (XRPD) of Compound (I) 2- hydroxyethanesulfonic acid salt Solid Form A.

[0049] FIG. 21B is the differential scanning colorimetry (DSC) of Compound (I) 2- hydroxyethanesulfonic acid salt Solid Form A.

[0050] FIG.22A is the powder X-ray diffractogram (XRPD) of Compound (I) p-toluenesulfonic acid salt Solid Form A.

[0051] FIG. 22B is the differential scanning colorimetry (DSC) of Compound (I) p- toluenesulfonic acid salt Solid Form A.

[0052] FIG.23A is the powder X-ray diffractogram (XRPD) of Compound (I) p-toluenesulfonic acid salt Solid Form B.

[0053] FIG. 23B is the differential scanning colorimetry (DSC) of Compound (I) p- toluenesulfonic acid salt Solid Form B.

[0054] FIG.24A is the powder X-ray diffractogram (XRPD) of Compound (I) p-toluenesulfonic acid salt Solid Form C.

[0055] FIG. 24B is the differential scanning colorimetry (DSC) of Compound (I) p- toluenesulfonic acid salt Solid Form C.

[0056] FIG.25A is the powder X-ray diffractogram (XRPD) of Compound (I) p-toluenesulfonic acid salt Solid Form D.

[0057] FIG. 25B is the differential scanning colorimetry (DSC) of Compound (I) p- toluenesulfonic acid salt Solid Form D.

[0058] FIG.26A is the powder X-ray diffractogram (XRPD) of Compound (I) methanesulfonic acid salt Solid Form A.

[0059] FIG.26B is the differential scanning colorimetry (DSC) of Compound (I) methanesulfonic acid salt Solid Form A.

[0060] FIG. 27A is the powder X-ray diffractogram (XRPD) of Compound (I) naphthalene-2- sulfonic acid salt Solid Form A.

[0061] FIG.27B is the differential scanning colorimetry (DSC) of Compound (I) naphthalene-2- sulfonic acid salt Solid Form A.

[0062] FIG. 28A is the powder X-ray diffractogram (XRPD) of Compound (I) benzenesulfonic acid salt Solid Form A.

[0063] FIG.28B is the differential scanning colorimetry (DSC) of Compound (I) benzenesulfonic acid salt Solid Form A.

[0064] FIG. 29A is the powder X-ray diffractogram (XRPD) of Compound (I) benzenesulfonic acid salt Solid Form B.

[0065] FIG.29B is the differential scanning colorimetry (DSC) of Compound (I) benzenesulfonic acid salt Solid Form B.

[0066] FIG. 30A is the powder X-ray diffractogram (XRPD) of Compound (I) benzenesulfonic acid salt Solid Form C.

[0067] FIG. 31A is the powder X-ray diffractogram (XRPD) of Compound (I) maleic acid salt Solid Form A.

[0068] FIG. 32A is the powder X-ray diffractogram (XRPD) of Compound (I) maleic acid salt Solid Form B.

[0069] FIG.32B is the differential scanning colorimetry (DSC) of Compound (I) maleic acid salt Solid Form B.

[0070] FIG. 33A is the powder X-ray diffractogram (XRPD) of Compound (I) maleic acid salt Solid Form C.

[0071] FIG.33B is the differential scanning colorimetry (DSC) of Compound (I) maleic acid salt Solid Form C.

[0072] FIG. 34A is the powder X-ray diffractogram (XRPD) of Compound (I) maleic acid salt Solid Form D.

[0073] FIG.34B is the differential scanning colorimetry (DSC) of Compound (I) maleic acid salt Solid Form D.

[0074] FIG. 35A is the powder X-ray diffractogram (XRPD) of Compound (I) maleic acid salt Solid Form E.

[0075] FIG.35B is the differential scanning colorimetry (DSC) of Compound (I) maleic acid salt Solid Form E.

[0076] FIG.36A is the powder X-ray diffractogram (XRPD) of Compound (I) aspartic acid salt Solid Form A / Free acid.

[0077] FIG.36B is the differential scanning colorimetry (DSC) of Compound (I) aspartic acid salt Solid Form A / Free acid.

[0078] FIG.37A is the powder X-ray diffractogram (XRPD) of Compound (I) aspartic acid salt Solid Form A / B / Free acid.

[0079] FIG.37B is the differential scanning colorimetry (DSC) of Compound (I) aspartic acid salt Solid Form A / B / Free acid.

[0080] FIG. 38A is the powder X-ray diffractogram (XRPD) of Compound (I) phosphoric acid salt Solid Form A.

[0081] FIG.38B is the differential scanning colorimetry (DSC) of Compound (I) phosphoric acid salt Solid Form A.

[0082] FIG. 39A is the powder X-ray diffractogram (XRPD) of Compound (I) phosphoric acid salt Solid Form B.

[0083] FIG.39B is the differential scanning colorimetry (DSC) of Compound (I) phosphoric acid salt Solid Form B.

[0084] FIG. 40A is the powder X-ray diffractogram (XRPD) of Compound (I) phosphoric acid salt Solid Form C.

[0085] FIG.41A is the powder X-ray diffractogram (XRPD) of Compound (I) (+)-camphor-10- sulfonic acid salt Solid Form A.

[0086] FIG. 41B is the differential scanning colorimetry (DSC) of Compound (I) (+)-camphor- 10-sulfonic acid salt Solid Form A.

[0087] FIG. 42A is the powder X-ray diffractogram (XRPD) of Compound (I) L-glutamic acid salt Solid Form A.

[0088] FIG.42B is the differential scanning colorimetry (DSC) of Compound (I) L-glutamic acid salt Solid Form A.

[0089] FIG. 43A is the powder X-ray diffractogram (XRPD) of Compound (I) L-glutamic acid salt Solid Form B / Free acid.

[0090] FIG.43B is the differential scanning colorimetry (DSC) of Compound (I) L-glutamic acid salt Solid Form B / Free acid.

[0091] FIG.44A is the powder X-ray diffractogram (XRPD) of Compound (I) malonic acid salt Solid Form A.

[0092] FIG. 44B is the differential scanning colorimetry (DSC) of Compound (I) malonic acid salt Solid Form A.

[0093] FIG.45A is the powder X-ray diffractogram (XRPD) of Compound (I) fumaric acid salt Solid Form A.

[0094] FIG.45B is the differential scanning colorimetry (DSC) of Compound (I) fumaric acid salt Solid Form A.

[0095] FIG.46A is the powder X-ray diffractogram (XRPD) of Compound (I) fumaric acid salt Solid Form B.

[0096] FIG.46B is the differential scanning colorimetry (DSC) of Compound (I) fumaric acid salt Solid Form B.

[0097] FIG.47A is the powder X-ray diffractogram (XRPD) of Compound (I) D-glucuronic acid salt Solid Form A.

[0098] FIG. 47B is the differential scanning colorimetry (DSC) of Compound (I) D-glucuronic acid salt Solid Form A.

[0099] FIG.48A is the powder X-ray diffractogram (XRPD) of Compound (I) glycolic acid salt Solid Form A.

[0100] FIG. 48B is the differential scanning colorimetry (DSC) of Compound (I) glycolic acid salt Solid Form A.

[0101] FIG. 49A is the powder X-ray diffractogram (XRPD) of Compound (I) malic acid salt Solid Form A.

[0102] FIG.49B is the differential scanning colorimetry (DSC) of Compound (I) malic acid salt Solid Form A.

[0103] FIG. 50A is the powder X-ray diffractogram (XRPD) of Compound (I) malic acid salt Solid Form B.

[0104] FIG.50B is the differential scanning colorimetry (DSC) of Compound (I) malic acid salt Solid Form B.

[0105] FIG. 51A is the powder X-ray diffractogram (XRPD) of Compound (I) malic acid salt Solid Form C.

[0106] FIG.51B is the differential scanning colorimetry (DSC) of Compound (I) malic acid salt Solid Form C.

[0107] FIG.52A is the powder X-ray diffractogram (XRPD) of Compound (I) hippuric acid salt Solid Form A.

[0108] FIG. 52B is the differential scanning colorimetry (DSC) of Compound (I) hippuric acid salt Solid Form A.

[0109] FIG.53A is the powder X-ray diffractogram (XRPD) of Compound (I) hippuric acid salt Solid Form B.

[0110] FIG. 53B is the differential scanning colorimetry (DSC) of Compound (I) hippuric acid salt Solid Form B.

[0111] FIG.54A is the powder X-ray diffractogram (XRPD) of Compound (I) hippuric acid salt Solid Form C.

[0112] FIG. 54B is the differential scanning colorimetry (DSC) of Compound (I) hippuric acid salt Solid Form C.

[0113] FIG.55A is the powder X-ray diffractogram (XRPD) of Compound (I) hippuric acid salt Solid Form D.

[0114] FIG.56A is the powder X-ray diffractogram (XRPD) of Compound (I) hippuric acid salt Solid Form E.

[0115] FIG. 56B is the differential scanning colorimetry (DSC) of Compound (I) hippuric acid salt Solid Form E.

[0116] FIG.57A is the powder X-ray diffractogram (XRPD) of Compound (I) hippuric acid salt Solid Form F.

[0117] FIG. 57B is the differential scanning colorimetry (DSC) of Compound (I) hippuric acid salt Solid Form F.

[0118] FIG. 58A is the powder X-ray diffractogram (XRPD) of Compound (I) L-ascorbic acid salt Solid Form A.

[0119] FIG.58B is the differential scanning colorimetry (DSC) of Compound (I) L-ascorbic acid salt Solid Form A.

[0120] FIG.59A is the powder X-ray diffractogram (XRPD) of Compound (I) succinic acid salt Solid Form A.

[0121] FIG. 59B is the differential scanning colorimetry (DSC) of Compound (I) succinic acid salt Solid Form A.

[0122] FIG. 60A is the powder X-ray diffractogram (XRPD) of Compound (I) adipic acid salt Solid Form A.

[0123] FIG.60B is the differential scanning colorimetry (DSC) of Compound (I) adipic acid salt Solid Form A.

[0124] FIG. 61A is the powder X-ray diffractogram (XRPD) of Compound (I) acetic acid salt Solid Form A.

[0125] FIG. 62A is the powder X-ray diffractogram (XRPD) of Compound (I) acetic acid salt Solid Form B.

[0126] FIG. 63A is the powder X-ray diffractogram (XRPD) of Compound (I) acetic acid salt Solid Form C.

[0127] FIG.63B is the differential scanning colorimetry (DSC) of Compound (I) acetic acid salt Solid Form C.

[0128] FIG. 64A is the powder X-ray diffractogram (XRPD) of Compound (I) 2- napthalenesulfonic acid salt.

[0129] FIG. 64B is the differential scanning colorimetry (DSC) of Compound (I) 2- napthalenesulfonic acid salt.

[0130] FIG.65A is the powder X-ray diffractogram (XRPD) of Compound (I) stearic acid salt.

[0131] FIG.65B is the differential scanning colorimetry (DSC) of Compound (I) stearic acid salt.

[0132] FIG.66A is the powder X-ray diffractogram (XRPD) of Compound (I) caprylic acid salt.

[0133] FIG. 66B is the differential scanning colorimetry (DSC) of Compound (I) caprylic acid salt.

[0134] FIG. 67A is the powder X-ray diffractogram (XRPD) of Compound (I) 1-hydroxy-2- napthoic acid salt.

[0135] FIG. 67B is the differential scanning colorimetry (DSC) of Compound (I) 1-hydroxy-2- napthoic acid salt.

[0136] FIG.68A is the powder X-ray diffractogram (XRPD) of Compound (I) decanoic acid salt.

[0137] FIG. 68B is the differential scanning colorimetry (DSC) of Compound (I) decanoic acid salt.

[0138] FIG.69A is the powder X-ray diffractogram (XRPD) of Compound (I) oleic acid salt.

[0139] FIG.69B is the differential scanning colorimetry (DSC) of Compound (I) oleic acid salt.

[0140] FIG.70A is the powder X-ray diffractogram (XRPD) of Compound (I) benzoic acid salt.

[0141] FIG. 70B is the differential scanning colorimetry (DSC) of Compound (I) benzoic acid salt. DETAILED DESCRIPTION Definitions

[0142] For convenience, certain terms employed in the specification, examples and claims are collected here. Unless defined otherwise, all technical and scientific terms used in this disclosure have the same meanings as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0143] The term “about” when immediately preceding a numerical value means a range (e.g., plus or minus 10% of that value). For example, “about 50” can mean 45 to 55, “about 25,000” can mean 22,500 to 27,500, etc., unless the context of the disclosure indicates otherwise, or is inconsistent with such an interpretation. For example, in a list of numerical values such as “about 49, about 50, about 55, ...”, “about 50” means a range extending to less than half the interval(s) between the preceding and subsequent values, e.g., more than 49.5 to less than 50.5.

[0144] The term “pharmaceutically acceptable” as used herein, refers to those compounds, materials, compositions, and / or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit / risk ratio.

[0145] The term “salts” as used herein embraces pharmaceutically acceptable salts commonly used to form alkali metal salts of free acids and to form addition salts of free bases. Salts include those obtained by reacting the active compound functioning as a base, with an inorganic or organic acid to form a salt, for example, salts of hydrochloric acid, sulfuric acid, phosphoric acid, methanesulfonic acid, camphorsulfonic acid, oxalic acid, maleic acid, succinic acid, citric acid, formic acid, hydrobromic acid, benzoic acid, tartaric acid, fumaric acid, salicylic acid, mandelic acid, carbonic acid, etc. Base addition salts include but are not limited to, ethylenediamine, N- methyl-glucamine, lysine, arginine, ornithine, choline, N,N'-dibenzylethylenediamine, chloroprocaine, diethanolamine, procaine, N-benzylphenethylamine, diethylamine, piperazine, tris-(hydroxymethyl)-aminomethane, tetramethylammonium hydroxide, triethylamine, dibenzylamine, ephenamine, dehydroabietylamine, N-ethylpiperidine, benzylamine, tetramethylammonium, tetraethylammonium, methylamine, dimethylamine, trimethylamine, ethylamine, basic amino acids, e. g., lysine and arginine dicyclohexylamine and the like. Examples of metal salts include lithium, sodium, potassium, magnesium, calcium salts and the like. Examples of ammonium and alkylated ammonium salts include ammonium, methylammonium, dimethylammonium, trimethylammonium, ethylammonium, hydroxyethylammonium, diethylammonium, butylammonium, tetramethylammonium salts and the like. Examples of organic bases include lysine, arginine, guanidine, diethanolamine, choline and the like. Those skilled in the art will further recognize that acid addition salts may be prepared by reaction of the compounds with the appropriate inorganic or organic acid via any of a number of known methods.

[0146] The term "treating" as used herein with regard to a patient, refers to improving at least one symptom of the patient's disorder. Treating can be improving, or at least partially ameliorating a disorder or an associated symptom of a disorder.

[0147] The terms "effective amount" and "therapeutically effective amount" are used interchangeably in this disclosure and refer to an amount of a compound, or a salt thereof, (or pharmaceutical composition containing the compound or salt) that, when administered to a patient, is capable of performing the intended result. The "effective amount" will vary depending on the active ingredient, the state, disorder, or condition to be treated and its severity, and the age, weight, physical condition and responsiveness of the mammal to be treated.

[0148] The term "therapeutically effective" applied to dose or amount refers to that quantity of a compound or pharmaceutical composition that is sufficient to result in a desired clinical benefit after administration to a patient in need thereof. Salts

[0149] In aspects, the present disclosure provides hydrobromic acid salt, naphthalene-1,5- disulfonic acid salt, sulfuric acid salt, ethane-1,2-disulfonic acid salt, ethanesulfonic acid salt, 2- hydroxyethanesulfonic acid salt, p-toluenesulfonic acid salt, methanesulfonic acid salt, naphthalene-2-sulfonic acid salt, benzenesulfonic acid salt, maleic acid salt, L-aspartic acid salt, phosphoric acid salt, (+)-camphor-10-sulfonic acid salt, L-glutamic acid salt, malonic acid salt, gentisic acid salt, fumaric acid salt, citric acid salt, D-glucuronic acid salt, glycolic acid salt, L- malic acid salt, hippuric acid salt, L-gluconic acid salt, DL-lactic acid salt, L-ascorbic acid salt, benzoic acid, succinic acid salt, adipic acid salt, and acetic acid salt of Compound (I).

[0150] In embodiments, the salt of Compound (I) is a hydrobromic acid salt.

[0151] In embodiments, the salt of Compound (I) is a naphthalene-1,5-disulfonic acid salt.

[0152] In embodiments, the salt of Compound (I) is a sulfuric acid salt.

[0153] In embodiments, the salt of Compound (I) is an ethane-1,2-disulfonic acid salt.

[0154] In embodiments, the salt of Compound (I) is an ethanesulfonic acid salt.

[0155] In embodiments, the salt of Compound (I) is a 2-hydroxyethanesulfonic acid salt.

[0156] In embodiments, the salt of Compound (I) is a p-toluenesulfonic acid salt.

[0157] In embodiments, the salt of Compound (I) is a methanesulfonic acid salt.

[0158] In embodiments, the salt of Compound (I) is a naphthalene-2-sulfonic acid salt.

[0159] In embodiments, the salt of Compound (I) is a benzenesulfonic acid salt.

[0160] In embodiments, the salt of Compound (I) is a maleic acid salt.

[0161] In embodiments, the salt of Compound (I) is an L-aspartic acid salt.

[0162] In embodiments, the salt of Compound (I) is a phosphoric acid salt.

[0163] In embodiments, the salt of Compound (I) is a (+)-camphor-10-sulfonic acid salt.

[0164] In embodiments, the salt of Compound (I) is an L-glutamic acid salt.

[0165] In embodiments, the salt of Compound (I) is a malonic acid salt.

[0166] In embodiments, the salt of Compound (I) is a gentisic acid salt.

[0167] In embodiments, the salt of Compound (I) is a fumaric acid salt.

[0168] In embodiments, the salt of Compound (I) is a citric acid salt.

[0169] In embodiments, the salt of Compound (I) is a D-glucuronic acid salt.

[0170] In embodiments, the salt of Compound (I) is a glycolic acid salt.

[0171] In embodiments, the salt of Compound (I) is an L-malic acid salt.

[0172] In embodiments, the salt of Compound (I) is a hippuric acid salt.

[0173] In embodiments, the salt of Compound (I) is an L-gluconic acid salt.

[0174] In embodiments, the salt of Compound (I) is a DL-lactic acid salt.

[0175] In embodiments, the salt of Compound (I) is an L-ascorbic acid salt.

[0176] In embodiments, the salt of Compound (I) is a benzoic acid.

[0177] In embodiments, the salt of Compound (I) is a succinic acid salt.

[0178] In embodiments, the salt of Compound (I) is an adipic acid salt.

[0179] In embodiments, the salt of Compound (I) is an acetic acid salt.

[0180] In aspects, the present disclosure provides 2-napthalenesulfonic acid salt, stearic acid salt, caprylic acid salt, 1-hydroxy-2-napthoic acid salt, decanoic acid salt, oleic acid salt, and benzoic acid salt of Compound (I).

[0181] In embodiments, the salt of Compound (I) is a 2-napthalenesulfonic acid salt.

[0182] In embodiments, the salt of Compound (I) is a stearic acid salt.

[0183] In embodiments, the salt of Compound (I) is a caprylic acid salt.

[0184] In embodiments, the salt of Compound (I) is a 1-hydroxy-2-napthoic acid salt.

[0185] In embodiments, the salt of Compound (I) is a decanoic acid salt.

[0186] In embodiments, the salt of Compound (I) is an oleic acid salt.

[0187] In embodiments, the salt of Compound (I) is a benzoic acid salt. Solid Forms

[0188] In aspects, the present disclosure provides solid forms of a hydrochloric acid salt of Compound (I).

[0189] In aspects, the present disclosure provides solid forms of a tartaric acid salt of Compound (I).

[0190] In aspects, the present disclosure provides solid forms of hydrobromic acid, naphthalene- 1,5-disulfonic acid, sulfuric acid, ethane-1,2-disulfonic acid, ethanesulfonic acid, 2- hydroxyethanesulfonic acid, p-toluenesulfonic acid, methanesulfonic acid, naphthalene-2-sulfonic acid, benzenesulfonic acid, maleic acid, L-aspartic acid, phosphoric acid, (+)-camphor-10-sulfonicacid, L-glutamic acid, malonic acid, gentisic acid, fumaric acid, citric acid, D-glucuronic acid, glycolic acid, L-malic acid, hippuric acid, L-gluconic acid, DL-lactic acid, L-ascorbic acid, benzoic acid, succinic acid, adipic acid, and acetic acid of Compound (I).

[0191] In aspects, the present disclosure provides solid forms of 2-napthalenesulfonic acid salt, stearic acid salt, caprylic acid salt, 1-hydroxy-2-napthoic acid salt, decanoic acid salt, oleic acid salt, and benzoic acid salt of Compound (I). Compound (I) HCl Salt Forms A and B (“HCl Salt Form A” and “HCl Salt Form B”)

[0192] In aspects, the present disclosure provides crystalline forms of hydrochloride salt of a compound of Formula (I):wherein the crystalline form is selected from: Form A, wherein the Form A is characterized by having X-ray powder diffraction peaks at 19.28 radiation, and Form B, wherein the Form B is characterized by having X-ray powder diffraction peaks at 18.95 ± 0.2, 20.70 radiation.

[0193] In embodiments, the crystalline form is Form A.

[0194] In embodiments, the Form A is characterized by having X-ray powder diffraction peaks at radiation.

[0195] In embodiments, Form A is characterized by having X-ray powder diffraction peaks at 19.29 ± 0.2, 22.84 ± 0.2, 21.53 ± 0.2, and 17.52 ± 0.2 radiation.

[0196] In embodiments, Form A is characterized by having X-ray powder diffraction peaks at 19.29 ± 0.2, 22.84 ± 0.2, 21.53 ± 0.2, 17.52 ± 0.2, 32.46 ± 0.2, and 20.35 ± 0.2 radiation.

[0197] In embodiments, Form A is characterized by having X-ray powder diffraction peaks at 19.29 ± 0.2, 22.84 ± 0.2, 21.53 ± 0.2, 17.52 ± 0.2, 32.46 ± 0.2, 20.35 ± 0.2, 18.57 ± 0.2, and 27.72 ± 0.2 radiation.

[0198] In embodiments, Form A is characterized by having X-ray powder diffraction peaks at 19.29 ± 0.2, 22.84 ± 0.2, 21.53 ± 0.2, 17.52 ± 0.2, 32.46 ± 0.2, 20.35 ± 0.2, 18.57 ± 0.2, 27.72 ± 0.2, 31.36 ± 0.2, 28.08 ± 0.2, and 32.53 ± 0.2 radiation.

[0199] In embodiments, the X-ray powder diffraction pattern of Form A is substantially the same as that set forth in Fig.3A.

[0200] In embodiments, the compound of Formula (1) is provided as the HCl salt wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, or at least 99 wt.% of the compound is in the form of crystalline Form A, the remainder being the amorphous form or other crystalline forms of the compound of Formula (1) HCl salt.

[0201] In embodiments, Form A is characterized by an endothermic event with an onset temperature at 180 ± 2.0 °C as measured by DSC (10 °C / min).

[0202] In embodiments, Form A is characterized by an endothermic event with a peak temperature at 186 ± 2.0 °C as measured by DSC (10 °C / min).

[0203] In embodiments, Form A is characterized by a DSC thermogram substantially the same to that set forth in Fig.3B.

[0204] In embodiments, the crystalline form is Form B.

[0205] In embodiments, Form B is characterized by having X-ray powder diffraction peaks at 18.95 ± 0.2, 20.70 radiation.

[0206] In embodiments, Form B is characterized by having X-ray powder diffraction peaks at 20.70 ± 0.2, 18.95 ± 0.2, 21.49 ± 0.2, 22.70 ± 0.2 radiation.

[0207] In embodiments, Form B is characterized by having X-ray powder diffraction peaks at 20.70 ± 0.2, 18.95 ± 0.2, 21.49 ± 0.2, 22.70 ± 0.2, 23.40 ± 0.2, and 19.41 ± 0.2 radiation.

[0208] In embodiments, Form B is characterized by having X-ray powder diffraction peaks at 20.70 ± 0.2, 18.95 ± 0.2, 21.49 ± 0.2, 22.70 ± 0.2, 23.40 ± 0.2, 19.41 ± 0.2, 30.40 ± 0.2, and 14.26 ± 0.2 radiation.

[0209] In embodiments, Form B is characterized by having X-ray powder diffraction peaks at 20.70 ± 0.2, 18.95 ± 0.2, 21.49 ± 0.2, 22.70 ± 0.2, 23.40 ± 0.2, 19.41 ± 0.2, 30.40 ± 0.2, 14.26 ± 0.2, 31.47 ± 0.2, and 27.87 ± 0.2 radiation.

[0210] In embodiments, the compound of Formula (1) is provided as the HCl salt wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, or at least 99 wt.% of the compound is in the formof crystalline Form B, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1) HCl salt.

[0211] In embodiments, the X-ray powder diffraction pattern of Form B is substantially the same as that set forth in Fig.2A.

[0212] In embodiments, Form B is characterized by an endothermic event with an onset temperature at 220 ± 2.0 °C as measured by DSC (10 °C / min).

[0213] In embodiments, Form B is characterized by an endothermic event with a peak temperature at 223 ± 2.0 °C as measured by DSC (10 °C / min).

[0214] In embodiments, Form B is characterized by a DSC thermogram substantially the same as that set forth in Fig.2B. Compound (I) Tartaric Acid Salt Forms A-G (“Tartaric Acid Salt Forms A-G”)

[0215] In aspects, the present disclosure provides crystalline forms of tartaric salt of a compound of Formula (I):wherein the crystalline form is selected from: Form A, wherein the Form A is characterized by having X-ray powder diffraction peaks at 16.22 ± 0.2, 18.34 ± 0.2, and 26.08 ± 0.2 radiation, Form B, wherein the Form B is characterized by having X-ray powder diffraction peaks at 12.72 ± 0.2, 16.05 ± 0.2, and 20.02 ± 0.2 radiation, Form C, wherein the Form C is characterized by having X-ray powder diffraction peaks at 13.76 ± 0.2, 18.08 ± 0.2, and 19.85 ± 0.2 radiation, Form D, wherein the Form D is characterized by having X-ray powder diffraction peaks at 16.04 ± 0.2, 19.85 ± 0.2, and 20.02 ± 0.2 radiation, Form E, wherein the Form E is characterized by having X-ray powder diffraction peaks at 15.94 ± 0.2, 19.88 ± 0.2, and 20.02 ± 0.2 radiation, Form F, wherein the Form F is characterized by having X-ray powder diffraction peaks at 16.16 ± 0.2, 19.26 ± 0.2, and 25.94 ± 0.2 radiation, andForm G, wherein the Form G is characterized by having X-ray powder diffraction peaks at 19.12 ± 0.2, 22.63 ± 0.2, and 27.79 ± 0.2 radiation.

[0216] In embodiments, the crystalline form is Form A.

[0217] In embodiments, the Form A is characterized by having X-ray powder diffraction peaks radiation.

[0218] In embodiments, the X-ray powder diffraction pattern of Form A is substantially the same to that set forth in Fig.3A.

[0219] In embodiments, the Form A is characterized by an endothermic event with an onset temperature at 180 ± 2.0 °C as measured by DSC (10 °C / min).

[0220] In embodiments, the Form A is characterized by an endothermic event with a peak temperature at 186 ± 2.0 °C as measured by DSC (10 °C / min).

[0221] In embodiments, the Form A is characterized by a DSC thermogram substantially the same to that set forth in Fig.3B.

[0222] In embodiments, the crystalline form is Form B.

[0223] In embodiments, the Form B is characterized by having X-ray powder diffraction peaks radiation.

[0224] In embodiments, the X-ray powder diffraction pattern of Form B is substantially the same to that set forth in Fig.4A.

[0225] In embodiments, the crystalline form is Form C.

[0226] In embodiments, the Form C is characterized by having X-ray powder diffraction peaks radiation.

[0227] In embodiments, the X-ray powder diffraction pattern of Form C is substantially the same to that set forth in Fig.5A.

[0228] In embodiments, the Form C is characterized by an endothermic event with an onset temperature at 180 ± 2.0 °C as measured by DSC (10 °C / min).

[0229] In embodiments, the Form C is characterized by an endothermic event with a peak temperature at 185 ± 2.0 °C as measured by DSC (10 °C / min).

[0230] In embodiments, the Form C is characterized by a DSC thermogram substantially the same to that set forth in Fig.5B.

[0231] In embodiments, the crystalline form is Form D.

[0232] In embodiments, the Form D is characterized by having X-ray powder diffraction peaks radiation.

[0233] In embodiments, the X-ray powder diffraction pattern of Form D is substantially the same to that set forth in Fig.6A.

[0234] In embodiments, the Form D is characterized by an endothermic event with an onset temperature at 175 ± 2.0 °C as measured by DSC (10 °C / min).

[0235] In embodiments, the Form D is characterized by an endothermic event with a peak temperature at 184 ± 2.0 °C as measured by DSC (10 °C / min).

[0236] In embodiments, the Form D is characterized by a DSC thermogram substantially the same to that set forth in Fig.6B.

[0237] In embodiments, the crystalline form is Form E.

[0238] In embodiments, the Form E is characterized by having X-ray powder diffraction peaks at radiation.

[0239] In embodiments, the X-ray powder diffraction pattern of Form E is substantially the same to that set forth in Fig.7A.

[0240] In embodiments, the Form E is characterized by an endothermic event with an onset temperature at 170 ± 2.0 °C as measured by DSC (10 °C / min).

[0241] In embodiments, the Form E is characterized by an endothermic event with a peak temperature at 181 ± 2.0 °C as measured by DSC (10 °C / min).

[0242] In embodiments, the Form E is characterized by a DSC thermogram substantially the same to that set forth in Fig.7B.

[0243] In embodiments, the crystalline form is Form F.

[0244] In embodiments, the Form F is characterized by having X-ray powder diffraction peaks at radiation.

[0245] In embodiments, the X-ray powder diffraction pattern of Form F is substantially the same to that set forth in Fig.8A.

[0246] In embodiments, the crystalline form is Form G.

[0247] In embodiments, the Form G is characterized by having X-ray powder diffraction peaks radiation.

[0248] In embodiments, the X-ray powder diffraction pattern of Form G is substantially the same to that set forth in Fig.9A.Compound (I) Hydrobromic Acid Salt Form A (“Hydrobromic Acid Salt Form A”)

[0249] In aspects, the present disclosure provides a hydrobromic acid salt of a compound of Formula (I):

[0250] In embodiments, the salt is a crystalline salt.

[0251] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 20.3 ± 0.2, 22.3 ± 0.2, and 24.9 ± 0.2 radiation.

[0252] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 20.3 ± 0.2, 22.3 ± 0.2, 23.6 ± 0.2, 24.9 ± 0.2, and 29.2 ± 0.2 radiation.

[0253] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.10A.

[0254] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 239 ± 2.0°C (10 °C / min).

[0255] In embodiments, the crystalline salt is Form A, characterized by a DSC thermogram having peak value at 241 ± 2.0 °C (10 °C / min).

[0256] In embodiments, the crystalline salt is Form A, characterized by a DSC thermogram that is substantially similar to Fig.10B. Compound (I) Naphthalene-1,5-Disulfonic Acid Salt Forms A-D (“Naphthalene-1,5-Disulfonic Acid Salt Forms A-D”)

[0257] In aspects, the present disclosure provides a naphthalene-1,5-disulfonic acid salt of a compound of Formula (I):

[0258] In embodiments, the salt is a crystalline salt.

[0259] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.1 ± 0.2, 16.5 ± 0.2, and 18.4 ± 0.2 radiation.

[0260] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.5 ± 0.2, 16.1 ± 0.2, 16.5 ± 0.2, 18.4 ± 0.2, and 23.0 ± 0.2 radiation.

[0261] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.11A.

[0262] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 127 ± 2.0°C and / or a peak temperature of 141 ± 2.0 °C (10 °C / min).

[0263] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.11B.

[0264] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.1 ± 0.2, 16.5 ± 0.2, and 18.4 ± 0.2 radiation.

[0265] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.5 ± 0.2, 16.1 ± 0.2, 16.5 ± 0.2, 18.4 ± 0.2, and 23.0 ± 0.2 radiation.

[0266] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.12A.

[0267] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 243 ± 2.0°C and / or a peak temperature of 249 ± 2.0 °C (10 °C / min).

[0268] In embodiments, the crystalline salt is Form B, characterized by a DSC thermogram that is substantially similar to Fig.12B.

[0269] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.1 ± 0.2, 18.1 ± 0.2, and 26.0 ± 0.2 radiation.

[0270] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.1 ± 0.2, 16.6 ± 0.2, 18.0 ± 0.2, 18.1 ± 0.2, and 26.0 ± 0.2 radiation.

[0271] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.13A.

[0272] In embodiments, the crystalline salt is Form C, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 132 ± 2.0°C and / or a peak temperature of 145 ± 2.0 °C (10 °C / min).

[0273] In embodiments, the crystalline salt is Form C, characterized by a DSC thermogram that is substantially similar to Fig.13B.

[0274] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.1 ± 0.2, 16.1 ± 0.2, and 23.0 ± 0.2 radiation.

[0275] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.1 ± 0.2, 16.1 ± 0.2, 22.7 ± 0.2, 23.0 ± 0.2, and 26.0 ± 0.2 radiation.

[0276] In embodiments, the crystalline salt is Form D, characterized by an XRPD pattern that is substantially similar to Fig.14A.

[0277] In embodiments, the crystalline salt is Form D, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 133 ± 2.0°C and / or a peak temperature of 147 ± 2.0 °C (10 °C / min).

[0278] In embodiments, the crystalline salt is Form D, characterized by a DSC thermogram that is substantially similar to Fig.14B. Compound (I) Sulfonic Acid Salt Forms A and B (“Sulfonic Acid Salt Forms A and B”)

[0279] In aspects, the present disclosure provides a sulfonic acid salt of a compound of Formula (I):

[0280] In embodiments, the salt is a crystalline salt.

[0281] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.1 ± 0.2, 17.6 ± 0.2, and 20.3 ± 0.2 radiation.

[0282] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.1 ± 0.2, 17.3 ± 0.2, 17.6 ± 0.2, 20.3 ± 0.2, and 26.7 ± 0.2 radiation.

[0283] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.15A.

[0284] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.15B.

[0285] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.7 ± 0.2, 16.3 ± 0.2, and 25.2 ± 0.2 radiation.

[0286] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.7 ± 0.2, 16.3 ± 0.2, 19.2 ± 0.2, 21.2 ± 0.2, and 25.2 ± 0.2 radiation.

[0287] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.16A.

[0288] In embodiments, the crystalline salt is Form B, characterized by a DSC thermogram that is substantially similar to Fig.16B. Compound (I) Ethane-1,2-Disulfonic Acid Salt Form A (“Ethane-1,2-Disulfonic Acid Form A”)

[0289] In aspects, the present disclosure provides an ethane-1,2-disulfonic acid salt of a compound of Formula (I):

[0290] In embodiments, the salt is a crystalline salt.

[0291] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.6 ± 0.2, 20.8 ± 0.2, and 21.4 ± 0.2 radiation.

[0292] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.6 ± 0.2, 19.0 ± 0.2, 20.8 ± 0.2, 21.4 ± 0.2, and 21.6 ± 0.2 radiation.

[0293] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.17A.

[0294] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.17B. Compound (I) Ethanesulfonic Acid Salt Forms A and B (“Ethanesulfonic Acid Salt Forms A and B”)

[0295] In aspects, the present disclosure provides an ethanesulfonic acid salt of a compound of Formula (I):

[0296] In embodiments, the salt is a crystalline salt.

[0297] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 22.1 ± 0.2, 22.2 ± 0.2, and 33.0 ± 0.2 radiation.

[0298] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 7.9 ± 0.2, 18.3 ± 0.2, 22.1 ± 0.2, 22.2 ± 0.2, and 33.0 ± 0.2 radiation.

[0299] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.18A.

[0300] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 95 ± 2.0°C and / or a peak temperature of 107 ± 2.0 °C (10 °C / min).

[0301] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.18B.

[0302] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.3 ± 0.2, 18.9 ± 0.2, and 22.9 ± 0.2 radiation.

[0303] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.3 ± 0.2, 17.8 ± 0.2, 18.9 ± 0.2, 22.9 ± 0.2, and 24.3 ± 0.2 radiation.

[0304] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.19A.

[0305] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 17.5 ± 0.2, 18.3 ± 0.2, and 20.6 ± 0.2 radiation.

[0306] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.1 ± 0.2, 15.7 ± 0.2, 17.5 ± 0.2, 18.3 ± 0.2, and 20.6 ± 0.2 radiation.

[0307] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.20A.

[0308] In embodiments, the crystalline salt is Form C, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 86 ± 2.0°C and / or a peak temperature of 94 ± 2.0 °C (10 °C / min).

[0309] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.20B.Compound (I) 2-Hydroxyethanesulfonic Acid Salt Form A (“2-Hydroxyethanesulfonic Acid Salt Form A”)

[0310] In aspects, the present disclosure provides a 2-hydroxyethanesulfonic acid salt of a compound of Formula (I):

[0311] In embodiments, the salt is a crystalline salt.

[0312] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 18.1 ± 0.2, 18.6 ± 0.2, and 19.4 ± 0.2 radiation.

[0313] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 7.1 ± 0.2, 18.1 ± 0.2, 18.6 ± 0.2, 19.4 ± 0.2, and 23.1± 0.2 radiation.

[0314] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.21A.

[0315] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 122 ± 2.0°C and / or a peak temperature of 127 ± 2.0 °C (10 °C / min).

[0316] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.21B. Compound (I) p-Toluenesulfonic Acid Salt Forms A-D (“p-Toluenesulfonic Acid Salt Forms A- D”)

[0317] In aspects, the present disclosure provides a p-toluenesulfonic acid salt of a compound of Formula (I):

[0318] In embodiments, the salt is a crystalline salt.

[0319] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.0 ± 0.2, 5.4 ± 0.2, and 19.0 ± 0.2 radiation.

[0320] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.0 ± 0.2, 5.4 ± 0.2, 17.8 ± 0.2, 19.0 ± 0.2, and 22.9 ± 0.2 radiation.

[0321] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.22A.

[0322] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 191 ± 2.0°C and / or a peak temperature of 197 ± 2.0 °C (10 °C / min).

[0323] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.22B.

[0324] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.4 ± 0.2, 19.0 ± 0.2, and 22.9 ± 0.2 radiation.

[0325] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.4 ± 0.2, 5.7 ± 0.2, 17.8 ± 0.2, 19.0 ± 0.2, and 22.9 ± 0.2 radiation.

[0326] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.23A.

[0327] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 192 ± 2.0°C and / or a peak temperature of 196 ± 2.0 °C (10 °C / min).

[0328] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.23B.

[0329] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 7.9 ± 0.2, 19.0 ± 0.2, and 22.9 ± 0.2 radiation.

[0330] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.4 ± 0.2, 7.9 ± 0.2, 17.8 ± 0.2, 19.0 ± 0.2, and 22.9 ± 0.2 radiation.

[0331] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.24A.

[0332] In embodiments, the crystalline salt is Form C, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 195 ± 2.0°C and / or a peak temperature of 199 ± 2.0 °C (10 °C / min).

[0333] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.24B.

[0334] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.4 ± 0.2, 19.0 ± 0.2, and 22.9 ± 0.2 radiation.

[0335] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.4 ± 0.2, 19.0 ± 0.2, 17.8 ± 0.2, 22.9 ± 0.2, and 24.3 ± 0.2 radiation.

[0336] In embodiments, the crystalline salt is Form D, characterized by an XRPD pattern that is substantially similar to Fig.25A.

[0337] In embodiments, the crystalline salt is Form D, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 194 ± 2.0°C and / or a peak temperature of 198 ± 2.0 °C.

[0338] In embodiments, the crystalline salt is Form D characterized by a DSC thermogram that is substantially similar to Fig.25B. Compound (I) Methanesulfonic Acid Salt Form A (“Methanesulfonic Acid Salt Form A”)

[0339] In aspects, the present disclosure provides a methanesulfonic acid salt of a compound of Formula (I):

[0340] In embodiments, the salt is a crystalline salt.

[0341] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 8.0 ± 0.2, 22.2 ± 0.2, and 31.9 ± 0.2 radiation.

[0342] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 8.0 ± 0.2, 11.1 ± 0.2, 20.6 ± 0.2, 22.2 ± 0.2, and 31.9 ± 0.2 radiation.

[0343] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.26A.

[0344] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 352 ± 2.0°C and / or a peak temperature of 354 ± 2.0 °C (10 °C / min).

[0345] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.26B. Compound (I) Naphthalene-2-Sulfonic Acid Salt Form A (“Naphthalene-2-Sulfonic Acid Salt Form A”)

[0346] In aspects, the present disclosure provides a naphthalene-2-sulfonic acid salt of a compound of Formula (I):

[0347] In embodiments, the salt is a crystalline salt.

[0348] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.4 ± 0.2, 18.5 ± 0.2, and 23.1 ± 0.2 radiation.

[0349] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.4 ± 0.2, 18.3 ± 0.2, 18.5 ± 0.2, 19.4 ± 0.2, and 23.1 ± 0.2 ± 0.2 radiation.

[0350] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.27A.

[0351] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 179 ± 2.0°C and / or a peak temperature of 183 ± 2.0 °C (10 °C / min).

[0352] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.27B. Compound (I) Benzenesulfonic Acid Salt Forms A-C (“Benzenesulfonic Acid Salt Forms A-C”)

[0353] In aspects, the present disclosure provides a benzenesulfonic acid salt of a compound of Formula (I):

[0354] In embodiments, the salt is a crystalline salt.

[0355] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.8 ± 0.2, 18.1 ± 0.2, and 19.0 ± 0.2 radiation.

[0356] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.8 ± 0.2, 5.9 ± 0.2, 18.1 ± 0.2, 19.0 ± 0.2, and 23.3 ± 0.2 radiation.

[0357] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.28A.

[0358] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 171 ± 2.0°C and / or a peak temperature of 175 ± 2.0 °C (10 °C / min).

[0359] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.28B.

[0360] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 18.0 ± 0.2, 19.0 ± 0.2, and 23.2 ± 0.2 radiation.

[0361] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 6.1 ± 0.2, 6.4 ± 0.2, 18.0 ± 0.2, 19.0 ± 0.2, and 23.2 ± 0.2 radiation.

[0362] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.29A.

[0363] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 177 ± 2.0°C and / or a peak temperature of 180 ± 2.0 °C (10 °C / min).

[0364] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.29B.

[0365] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.8 ± 0.2, 6.1 ± 0.2, and 19.0 ± 0.2 radiation.

[0366] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 5.8 ± 0.2, 6.1 ± 0.2, 18.1 ± 0.2, 19.0 ± 0.2, and 23.2 ± 0.2 radiation.

[0367] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.30A. Compound (I) Maleic Acid Salt Forms A-E (“Maleic Acid Salt Forms A-E”)

[0368] In aspects, the present disclosure provides a maleic acid salt of a compound of Formula (I):

[0369] In embodiments, the salt is a crystalline salt.

[0370] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.1 ± 0.2, 28.3 ± 0.2, and 29.3 ± 0.2 radiation.

[0371] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.1 ± 0.2, 18.9 ± 0.2, 28.0 ± 0.2, 28.3 ± 0.2, and 29.3 ± 0.2 radiation.

[0372] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.31A.

[0373] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.6 ± 0.2, 20.1 ± 0.2, and 26.3 ± 0.2 radiation.

[0374] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.1 ± 0.2, 15.6 ± 0.2, 20.1 ± 0.2, 21.1 ± 0.2, and 26.3 ± 0.2 radiation.

[0375] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.32A.

[0376] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 127 ± 2.0°C and / or a peak temperature of 130 ± 2.0 °C (10 °C / min).

[0377] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.32B.

[0378] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.4 ± 0.2, 16.8 ± 0.2, and 21.1 ± 0.2 radiation.

[0379] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 7.6 ± 0.2, 15.4 ± 0.2, 16.8 ± 0.2, 20.1 ± 0.2, and 21.1 ± 0.2 radiation.

[0380] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.33A.

[0381] In embodiments, the crystalline salt is Form C characterized by a DSC thermogram that is substantially similar to Fig.33B.

[0382] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 10.8 ± 0.2, 18.7 ± 0.2, and 26.4 ± 0.2 radiation.

[0383] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 10.8 ± 0.2, 18.7 ± 0.2, 26.4 ± 0.2, 30.0 ± 0.2, and 30.6 ± 0.2 radiation.

[0384] In embodiments, the crystalline salt is Form D, characterized by an XRPD pattern that is substantially similar to Fig.34A.

[0385] In embodiments, the crystalline salt is Form D characterized by a DSC thermogram that is substantially similar to Fig.34B.

[0386] In embodiments, the crystalline salt is Form E, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.1 ± 0.2, 28.3 ± 0.2, and 28.4 ± 0.2 radiation.

[0387] In embodiments, the crystalline salt is Form E, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.1 ± 0.2, 28.3 ± 0.2, 28.4 ± 0.2, 29.3 ± 0.2, and 29.4 ± 0.2 radiation.

[0388] In embodiments, the crystalline salt is Form E, characterized by an XRPD pattern that is substantially similar to Fig.35A.

[0389] In embodiments, the crystalline salt is Form E characterized by a DSC thermogram that is substantially similar to Fig.35B. Compound (I) Aspartic Acid Salt Form A (“Aspartic Acid Salt Form A”)

[0390] In aspects, the present disclosure provides an aspartic acid salt of a compound of Formula (I):

[0391] In embodiments, the salt is a crystalline salt.

[0392] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 21.7 ± 0.2, 28.2 ± 0.2, and 31.1 ± 0.2 radiation.

[0393] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 21.7 ± 0.2, 22.8 ± 0.2, 25.6 ± 0.2, 28.2 ± 0.2, and 31.1 ± 0.2 radiation.

[0394] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.36A.

[0395] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 249 ± 2.0°C and / or a peak temperature of 265 ± 2.0 °C (10 °C / min).

[0396] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.36B. Compound (I) phosphoric Acid Salt Forms A-C (“phosphoric Acid Salt Forms A-C”)

[0397] In aspects, the present disclosure provides a phosphoric acid salt of a compound of Formula (I):

[0398] In embodiments, the salt is a crystalline salt.

[0399] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.0 ± 0.2, 20.2 ± 0.2, and 21.9 ± 0.2 radiation.

[0400] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 7.1 ± 0.2, 15.0 ± 0.2, 18.1 ± 0.2, 20.2 ± 0.2, and 21.9 ± 0.2 radiation.

[0401] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.38A.

[0402] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 204 ± 2.0°C and / or a peak temperature of 213 ± 2.0 °C (10 °C / min).

[0403] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.38B.

[0404] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 17.0 ± 0.2, 22.9 ± 0.2, and 23.0 ± 0.2 radiation.

[0405] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.4 ± 0.2, 17.0 ± 0.2, 20.8 ± 0.2, 22.9 ± 0.2, and 23.0 ± 0.2 radiation.

[0406] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.39A.

[0407] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 199 ± 2.0°C and / or a peak temperature of 210 ± 2.0 °C (10 °C / min).

[0408] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.39B.

[0409] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.2 ± 0.2, 17.0 ± 0.2, and 23.8 ± 0.2 radiation.

[0410] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.2 ± 0.2, 17.0 ± 0.2, 20.7 ± 0.2, 23.8 ± 0.2, and 24.7 ± 0.2 radiation.

[0411] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.40A.Compound (I) (+)-Camphor-10-sulfonic Acid Salt Form A (“(+)-Camphor-10-sulfonic Acid Salt Form A”)

[0412] In aspects, the present disclosure provides a (+)-camphor-10-sulfonic acid salt of a compound of Formula (I):

[0413] In embodiments, the salt is a crystalline salt.

[0414] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 8.1 ± 0.2, 14.2 ± 0.2, and 17.9 ± 0.2 radiation.

[0415] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 8.1 ± 0.2, 13.3 ± 0.2, 14.2 ± 0.2, 17.6 ± 0.2, and 17.9 ± 0.2 radiation.

[0416] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.41A.

[0417] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 153 ± 2.0°C and / or a peak temperature of 156 ± 2.0 °C (10 °C / min).

[0418] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.41B. Compound (I) L-glutamic acid Salt Forms A and B (“L-glutamic acid Salt Forms A and B”)

[0419] In aspects, the present disclosure provides an L-glutamic acid salt of a compound of Formula (I):

[0420] In embodiments, the salt is a crystalline salt.

[0421] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 21.4 ± 0.2, 22.1 ± 0.2, and 25.6 ± 0.2 radiation.

[0422] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 21.4 ± 0.2, 22.1 ± 0.2, 25.6 ± 0.2, 26.1 ± 0.2, and 31.0 ± 0.2 radiation.

[0423] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.42A.

[0424] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 205 ± 2.0°C and / or a peak temperature of 206 ± 2.0 °C (10 °C / min).

[0425] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.42B.

[0426] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 21.5 ± 0.2, 22.1 ± 0.2, and 25.7 ± 0.2 radiation.

[0427] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 20.1 ± 0.2, 21.5 ± 0.2, 22.1 ± 0.2, 25.7 ± 0.2, and 31.1 ± 0.2 radiation.

[0428] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.43A.

[0429] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 208 ± 2.0°C and / or a peak temperature of 209 ± 2.0 °C (10 °C / min).

[0430] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.43B. Compound (I) Malonic Acid Salt Form A (“Malonic Acid Salt Form A”)

[0431] In aspects, the present disclosure provides a malonic acid salt of a compound of Formula (I):

[0432] In embodiments, the salt is a crystalline salt.

[0433] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.1 ± 0.2, 20.7 ± 0.2, and 26.1 ± 0.2 radiation.

[0434] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.2 ± 0.2, 16.1 ± 0.2, 16.3 ± 0.2, 20.7 ± 0.2, and 26.1 ± 0.2 radiation.

[0435] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.44A.

[0436] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 141 ± 2.0°C and / or a peak temperature of 158 ± 2.0 °C (10 °C / min).

[0437] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.44B. Compound (I) Fumaric Acid Salt Forms A and B (“Fumaric Acid Salt Forms A and B”)

[0438] In aspects, the present disclosure provides a fumaric acid salt of a compound of Formula (I):

[0439] In embodiments, the salt is a crystalline salt.

[0440] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.2 ± 0.2, 20.5 ± 0.2, and 21.4 ± 0.2 radiation.

[0441] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.2 ± 0.2, 19.0 ± 0.2, 20.5 ± 0.2, 21.4 ± 0.2, and 29.1 ± 0.2 radiation.

[0442] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.45A.

[0443] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 145 ± 2.0°C and / or a peak temperature of 149 ± 2.0 °C (10 °C / min).

[0444] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.45B.

[0445] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 18.7 ± 0.2, 19.1 ± 0.2, and 20.2 ± 0.2 radiation.

[0446] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 12.2 ± 0.2, 18.7 ± 0.2, 19.1 ± 0.2, 20.2 ± 0.2, and 21.5 ± 0.2 radiation.

[0447] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.46A.

[0448] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 155 ± 2.0°C and / or a peak temperature of 159 ± 2.0 °C (10 °C / min).

[0449] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.46B. Compound (I) D-Glucuronic Acid Salt Form A (“D-Glucuronic Acid Salt Form A”)

[0450] In aspects, the present disclosure provides a D-glucuronic acid salt of a compound of Formula (I):

[0451] In embodiments, the salt is a crystalline salt.

[0452] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.2 ± 0.2, 13.6 ± 0.2, and 14.3 ± 0.2 radiation.

[0453] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.2 ± 0.2, 13.6 ± 0.2, 14.3 ± 0.2, 18.1 ± 0.2, and 25.0 ± 0.2 radiation.

[0454] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.47A.

[0455] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 164 ± 2.0°C and / or a peak temperature of 171 ± 2.0 °C (10 °C / min).

[0456] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.47B. Compound (I) Glycolic Acid Salt Form A (“Glycolic Acid Salt Form A”)

[0457] In aspects, the present disclosure provides a glycolic acid salt of a compound of Formula (I):

[0458] In embodiments, the salt is a crystalline salt.

[0459] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.6 ± 0.2, 19.6 ± 0.2, and 23.3 ± 0.2 radiation.

[0460] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.6 ± 0.2, 19.6 ± 0.2, 21.9 ± 0.2, 23.3 ± 0.2, and 24.0 ± 0.2 radiation.

[0461] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.48A.

[0462] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 108 ± 2.0°C and / or a peak temperature of 110 ± 2.0 °C (10 °C / min).

[0463] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.48B. Compound (I) Malic Acid Salt Forms A-C (“Malic Acid Salt Forms A-C”)

[0464] In aspects, the present disclosure provides a malic acid salt of a compound of Formula (I):

[0465] In embodiments, the salt is a crystalline salt.

[0466] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.5 ± 0.2, 20.5 ± 0.2, and 21.0 ± 0.2 radiation.

[0467] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.4 ± 0.2, 16.5 ± 0.2, 16.7 ± 0.2, 20.5 ± 0.2, and 21.0 ± 0.2 radiation.

[0468] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.49A.

[0469] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 137 ± 2.0°C and / or a peak temperature of 141 ± 2.0 °C (10 °C / min).

[0470] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.49B.

[0471] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.8 ± 0.2, 19.0 ± 0.2, and 23.3 ± 0.2 radiation.

[0472] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 16.8 ± 0.2, 17.7 ± 0.2, 18.0 ± 0.2, 19.0 ± 0.2, and 23.3 ± 0.2 radiation.

[0473] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.50A.

[0474] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 116 ± 2.0°C and / or a peak temperature of 119 ± 2.0 °C (10 °C / min).

[0475] In embodiments, the crystalline salt is Form B characterized by a DSC thermogram that is substantially similar to Fig.50B.

[0476] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.3 ± 0.2, 20.5 ± 0.2, and 20.9 ± 0.2 radiation.

[0477] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.0 ± 0.2, 15.3 ± 0.2, 17.2 ± 0.2, 20.5 ± 0.2, and 20.9 ± 0.2 radiation.

[0478] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.51A.

[0479] In embodiments, the crystalline salt is Form C, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 78 ± 2.0°C and / or 114 ± 2.0°C, and / or a peak temperature of 86 ± 2.0 °C and / or 118 ± 2.0 °C (10 °C / min).

[0480] In embodiments, the crystalline salt is Form C, characterized by a DSC thermogram that is substantially similar to Fig.51B. Compound (I) Hippuric Acid Salt Forms A-F (“Hippuric Acid Salt Forms A-F”)

[0481] In aspects, the present disclosure provides a hippuric acid salt of a compound of Formula (I):

[0482] In embodiments, the salt is a crystalline salt.

[0483] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 19.4 ± 0.2, 21.9 ± 0.2, and 22.4 ± 0.2 radiation.

[0484] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.8 ± 0.2, 19.4 ± 0.2, 21.9 ± 0.2, 22.4 ± 0.2, and 26.8 ± 0.2 radiation.

[0485] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.52A.

[0486] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 109 ± 2.0°C and / or a peak temperature of 113 ± 2.0 °C (10 °C / min).

[0487] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.52B.

[0488] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.7 ± 0.2, 18.4 ± 0.2, and 21.8 ± 0.2 radiation.

[0489] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.7 ± 0.2, 9.5 ± 0.2, 15.1 ± 0.2, 18.4 ± 0.2, and 21.8 ± 0.2 radiation.

[0490] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.53A.

[0491] In embodiments, the crystalline salt is Form B, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 103 ± 2.0°C and / or a peak temperature of 109 ± 2.0 °C (10 °C / min).

[0492] In embodiments, the crystalline salt is Form B, characterized by a DSC thermogram that is substantially similar to Fig.53B.

[0493] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 18.3 ± 0.2, 21.1 ± 0.2, and 22.3 ± 0.2 radiation.

[0494] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 18.3 ± 0.2, 18.5 ± 0.2, 18.7 ± 0.2, 21.1 ± 0.2, and 22.3 ± 0.2 radiation.

[0495] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.54A.

[0496] In embodiments, the crystalline salt is Form C, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 109 ± 2.0°C and / or a peak temperature of 113 ± 2.0 °C (10 °C / min).

[0497] In embodiments, the crystalline salt is Form C, characterized by a DSC thermogram that is substantially similar to Fig.54B.

[0498] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.7 ± 0.2, 18.3 ± 0.2, and 19.1 ± 0.2 radiation.

[0499] In embodiments, the crystalline salt is Form D, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.7 ± 0.2, 15.1 ± 0.2, 18.3 ± 0.2, 22.5 ± 0.2, and 19.1 ± 0.2 radiation.

[0500] In embodiments, the crystalline salt is Form D, characterized by an XRPD pattern that is substantially similar to Fig.55A.

[0501] In embodiments, the crystalline salt is Form E, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 19.1 ± 0.2, 19.4 ± 0.2, and 22.4 ± 0.2 radiation.

[0502] In embodiments, the crystalline salt is Form E, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 4.8 ± 0.2, 18.8 ± 0.2, 19.1 ± 0.2, 19.4 ± 0.2, and 22.4 ± 0.2 radiation.

[0503] In embodiments, the crystalline salt is Form E, characterized by an XRPD pattern that is substantially similar to Fig.56A.

[0504] In embodiments, the crystalline salt is Form E, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 104 ± 2.0°C and / or a peak temperature of 109 ± 2.0 °C (10 °C / min).

[0505] In embodiments, the crystalline salt is Form E, characterized by a DSC thermogram that is substantially similar to Fig.56B.

[0506] In embodiments, the crystalline salt is Form F, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 21.9 ± 0.2, 22.0 ± 0.2, and 23.0 ± 0.2 radiation.

[0507] In embodiments, the crystalline salt is Form F, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 19.1 ± 0.2, 21.9 ± 0.2, 22.0 ± 0.2, 23.0 ± 0.2, and 26.8 ± 0.2 radiation.

[0508] In embodiments, the crystalline salt is Form F, characterized by an XRPD pattern that is substantially similar to Fig.57A.

[0509] In embodiments, the crystalline salt is Form F, characterized by a DSC thermogram that is substantially similar to Fig.57B. Compound (I) L-Ascorbic Acid Salt Form A (“L-Ascorbic Acid Salt Form A”)

[0510] In aspects, the present disclosure provides an L-ascorbic acid salt of a compound of Formula (I):

[0511] In embodiments, the salt is a crystalline salt.

[0512] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 14.2 ± 0.2, 17.8 ± 0.2, and 18.3 ± 0.2 radiation.

[0513] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 8.1 ± 0.2, 14.2 ± 0.2, 17.6 ± 0.2, 17.8 ± 0.2, and 18.3 ± 0.2 radiation.

[0514] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.58A.

[0515] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.58B. Compound (I) Succinic Acid Salt Form A (“Succinic Acid Salt Form A”)

[0516] In aspects, the present disclosure provides a succinic acid salt of a compound of Formula (I):

[0517] In embodiments, the salt is a crystalline salt.

[0518] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.3 ± 0.2, 13.8 ± 0.2, and 24.0 ± 0.2 radiation.

[0519] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 13.3 ± 0.2, 13.8 ± 0.2, 18.6 ± 0.2, 22.1 ± 0.2, and 24.0 ± 0.2 radiation.

[0520] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.59A.

[0521] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 111 ± 2.0°C and / or a peak temperature of 113 ± 2.0 °C (10 °C / min).

[0522] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.59B. Compound (I) Adipic Acid Salt Form A (“Adipic Acid Salt Form A”)

[0523] In aspects, the present disclosure provides an adipic acid salt of a compound of Formula (I):

[0524] In embodiments, the salt is a crystalline salt.

[0525] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 9.7 ± 0.2, 20.6 ± 0.2, and 22.4 ± 0.2 radiation.

[0526] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 9.7 ± 0.2, 16.8 ± 0.2, 20.1 ± 0.2, 20.6 ± 0.2, and 22.4 ± 0.2 radiation.

[0527] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.60A.

[0528] In embodiments, the crystalline salt is Form A, characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event with an onset temperature of 109 ± 2.0°C and / or a peak temperature of 113 ± 2.0 °C. (10 °C / min).

[0529] In embodiments, the crystalline salt is Form A characterized by a DSC thermogram that is substantially similar to Fig.60B. Compound (I) Acetic Acid Salt Forms A-C (“Acetic Acid Salt Forms A-C”)

[0530] In aspects, the present disclosure provides an acetic acid salt of a compound of Formula (I):

[0531] In embodiments, the salt is a crystalline salt.

[0532] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 19.4 ± 0.2, 20.0 ± 0.2, and 21.1 ± 0.2 radiation.

[0533] In embodiments, the crystalline salt is Form A, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 15.0 ± 0.2, 19.4 ± 0.2, 20.0 ± 0.2, 21.1 ± 0.2, and 24.5 ± 0.2 radiation.

[0534] In embodiments, the crystalline salt is Form A, characterized by an XRPD pattern that is substantially similar to Fig.61A.

[0535] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 8.9 ± 0.2, 21.7 ± 0.2, and 23.6 ± 0.2 radiation.

[0536] In embodiments, the crystalline salt is Form B, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 8.9 ± 0.2, 17.0 ± 0.2, 21.7 ± 0.2, 23.6 ± 0.2, and 26.8 ± 0.2 radiation.

[0537] In embodiments, the crystalline salt is Form B, characterized by an XRPD pattern that is substantially similar to Fig.62A.

[0538] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 9.7 ± 0.2, 22.6 ± 0.2, and 22.9 ± 0.2 radiation.

[0539] In embodiments, the crystalline salt is Form C, characterized by an X-ray powder diffraction (XRPD) pattern having peaks at 9.0 ± 0.2, 9.7 ± 0.2, 16.3 ± 0.2, 22.6 ± 0.2, and 22.9 ± 0.2 radiation.

[0540] In embodiments, the crystalline salt is Form C, characterized by an XRPD pattern that is substantially similar to Fig.63A.

[0541] In embodiments, the crystalline salt is Form C, characterized by a DSC thermogram that is substantially similar to Fig.63B. Compound (I) 2-Napthalenesulfonic Acid Salt and Solid Forms

[0542] In aspects, the present disclosure provides a 2-napthalenesulfonic acid salt of a compound of Formula (I):

[0543] In embodiments, the salt is a crystalline salt.

[0544] In embodiments, the crystalline salt is characterized by an XRPD pattern that is substantially similar to Fig.64A.

[0545] In embodiments, the crystalline salt is characterized by a DSC thermogram that is substantially similar to Fig.64B. Compound (I) Stearic Acid Salt and Solid Forms

[0546] In aspects, the present disclosure provides a stearic acid salt of a compound of Formula (I):

[0547] In embodiments, the salt is a crystalline salt.

[0548] In embodiments, the crystalline salt is characterized by an XRPD pattern that is substantially similar to Fig.65A. In embodiments, the crystalline salt is characterized by a DSC thermogram that is substantially similar to Fig.65B. Compound (I) Caprylic Acid Salt and Solid Forms

[0549] In aspects, the present disclosure provides a caprylic acid salt of a compound of Formula (I):

[0550] In embodiments, the salt is a crystalline salt.

[0551] In embodiments, the crystalline salt is characterized by an XRPD pattern that is substantially similar to Fig.66A. In embodiments, the crystalline salt is characterized by a DSC thermogram that is substantially similar to Fig.66B.Compound (I) 1-Hydroxy-2-Napthoic Acid Salt and Solid Forms

[0552] In aspects, the present disclosure provides a 1-hydroxy-2-napthoic acid salt of a compound of Formula (I):

[0553] In embodiments, the salt is a crystalline salt.

[0554] In embodiments, the crystalline salt is characterized by an XRPD pattern that is substantially similar to Fig.67A.

[0555] In embodiments, the crystalline salt is characterized by a DSC thermogram that is substantially similar to Fig.67B. Compound (I) Decanoic Acid Salt and Solid Forms

[0556] In aspects, the present disclosure provides a decanoic acid salt of a compound of Formula (I):

[0557] In embodiments, the salt is a crystalline salt.

[0558] In embodiments, the crystalline salt is characterized by an XRPD pattern that is substantially similar to Fig.68A.

[0559] In embodiments, the crystalline salt is characterized by a DSC thermogram that is substantially similar to Fig.68B. Compound (I) Oleic Acid Salt and Solid Forms

[0560] In aspects, the present disclosure provides an oleic acid salt of a compound of Formula (I):

[0561] In embodiments, the salt is a crystalline salt.

[0562] In embodiments, the crystalline salt is characterized by an XRPD pattern that is substantially similar to Fig.69A.

[0563] In embodiments, the crystalline salt is characterized by a DSC thermogram that is substantially similar to Fig.69B. Compound (I) Benzoic Acid Salt and Solid Forms

[0564] In aspects, the present disclosure provides a benzoic acid salt of a compound of Formula (I):

[0565] In embodiments, the salt is a crystalline salt.

[0566] In embodiments, the crystalline salt is characterized by an XRPD pattern that is substantially similar to Fig.70A.

[0567] In embodiments, the crystalline salt is characterized by a DSC thermogram that is substantially similar to Fig.70B.

[0568]

[0569] All forms of the compounds of the present application are contemplated, either in a mixture or in pure or substantially pure form, including crystalline forms of racemic mixtures and crystalline forms of individual isomers.

[0570] Polymorphs of a molecule can be obtained by a number of methods, as known in the art. Such methods include, but are not limited to, melt recrystallization, melt cooling, solvent recrystallization, desolvation, rapid evaporation, rapid cooling, slow cooling, vapor diffusion, and sublimation.

[0571] Techniques for characterizing solid forms of a compound, such as polymorphs, include, but are not limited to, DSC , X-ray powder diffractometry (XRPD), single crystal X-ray diffractometry, vibrational spectroscopy (e.g., IR or Raman spectroscopy), TGA, DTA, DVS, solid state NMR, hot stage optical microscopy, scanning electron microscopy (SEM), electron crystallography and quantitative analysis, particle size analysis (PSA), surface area analysis, solubility studies, and dissolution studies. Pharmaceutical Compositions

[0572] The present disclosure provides pharmaceutical compositions comprising one or more salts or solid forms disclosed herein and pharmaceutically acceptable carriers or excipients.

[0573] In aspects, the present disclosure also provides pharmaceutical compositions comprising a Compound (I) HCl salt and at least one pharmaceutically acceptable excipient or carrier.

[0574] In embodiments, the Compound (I) HCl salt is HCl salt Form A.

[0575] In embodiments, the pharmaceutical composition comprises the compound of Formula (1), wherein the compound of Formula (1) is provided as the HCl salt wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, or at least 99 wt.% of the compound is in the form of crystalline Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1).

[0576] In embodiments, the composition includes one or more additional therapeutic agents.

[0577] In embodiments the composition includes one or more additional agents for the treatment of schizophrenia, for example an antipsychotic (including typical and atypical antipsychotics). In some implementations the composition includes amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, chlorpromazine, clozapine, fluphaenazine, haloperidol, iloperidone, lumateperone, lurasidone, olanzapine, paliperidone, perphenazine, quetiapine, risperidone, thioridazine, thiothixene, trifluoperazine, xanomeline, ziprasidone, a salt thereof, or a combination thereof.

[0578] In embodiments the composition includes one or more additional agents for the treatment of Alzheimer’s disease. In some embodiments the composition includes a cholinesterase inhibitor, for example donepezil, galantamine, or rivastigmine. In some embodiments the composition includes a muscarinic antagonist, for example atropine, hyoscyamine, fesoterodine, hyoscine,ipratropium, tropicamide, cyclopentolate, pirenzepine, scopolamine, a salt thereof, or a combination thereof.

[0579] In embodiments the composition includes memantine or a salt thereof.

[0580] In embodiments, the pharmaceutical composition further includes fesoterodine or a salt thereof, preferably fesoterodine fumarate.

[0581] In embodiments, the Compound (I) HCl salt is HCl salt Form B.

[0582] In aspects, the present disclosure provides pharmaceutical compositions comprising a Compound (I) tartrate salt and at least one pharmaceutically acceptable excipient or carrier.

[0583] In embodiments, the Compound (I) tartrate salt is tartrate salt Form A.

[0584] In embodiments, the Compound (I) tartrate salt is tartrate salt Form B.

[0585] In embodiments, the Compound (I) tartrate salt is tartrate salt Form C.

[0586] In embodiments, the Compound (I) tartrate salt is tartrate salt Form D.

[0587] In embodiments, the Compound (I) tartrate salt is tartrate salt Form E.

[0588] In embodiments, the Compound (I) tartrate salt is tartrate salt Form F.

[0589] In a further aspect, the present disclosure provides pharmaceutical compositions comprising 2-napthalenesulfonic acid salt, stearic acid salt, caprylic acid salt, 1-hydroxy-2- napthoic acid salt, decanoic acid salt, oleic acid salt, or benzoic acid salt of Compound (I), and at least one pharmaceutically acceptable excipient or carrier.

[0590] In embodiments, the salt is 2-napthalenesulfonic acid salt.

[0591] In embodiments, the salt of Compound (I) is stearic acid salt.

[0592] In embodiments, the salt of Compound (I) is caprylic acid salt.

[0593] In embodiments, the salt of Compound (I) is 1-hydroxy-2-napthoic acid salt.

[0594] In embodiments, the salt of Compound (I) is decanoic acid salt.

[0595] In embodiments, the salt of Compound (I) is oleic acid salt.

[0596] In embodiments, the salt of Compound (I) is benzoic acid salt.

[0597] In a further aspect, the present disclosure provides pharmaceutical compositions comprising hydrobromic acid salt, naphthalene-1,5-disulfonic acid salt, sulfuric acid salt, ethane- 1,2-disulfonic acid salt, ethanesulfonic acid salt, 2-hydroxyethanesulfonic acid salt, p- toluenesulfonic acid salt, methanesulfonic acid salt, naphthalene-2-sulfonic acid salt, benzenesulfonic acid salt, maleic acid salt, L-aspartic acid salt, phosphoric acid salt, (+)-camphor- 10-sulfonic acid salt, L-glutamic acid salt, malonic acid salt, gentisic acid salt, fumaric acid salt,citric acid salt, D-glucuronic acid salt, glycolic acid salt, L-malic acid salt, hippuric acid salt, L- gluconic acid salt, DL-lactic acid salt, L-ascorbic acid salt, benzoic acid, succinic acid salt, adipic acid salt, or acetic acid salt of Compound (I), and at least one pharmaceutically acceptable excipient or carrier.

[0598] In embodiments, the salt of Compound (I) is a hydrobromic acid salt.

[0599] In embodiments, the salt of Compound (I) is a naphthalene-1,5-disulfonic acid salt.

[0600] In embodiments, the salt of Compound (I) is a sulfuric acid salt.

[0601] In embodiments, the salt of Compound (I) is an ethane-1,2-disulfonic acid salt.

[0602] In embodiments, the salt of Compound (I) is an ethanesulfonic acid salt.

[0603] In embodiments, the salt of Compound (I) is a 2-hydroxyethanesulfonic acid salt.

[0604] In embodiments, the salt of Compound (I) is a p-toluenesulfonic acid salt.

[0605] In embodiments, the salt of Compound (I) is a methanesulfonic acid salt.

[0606] In embodiments, the salt of Compound (I) is a naphthalene-2-sulfonic acid salt.

[0607] In embodiments, the salt of Compound (I) is a benzenesulfonic acid salt.

[0608] In embodiments, the salt of Compound (I) is a maleic acid salt.

[0609] In embodiments, the salt of Compound (I) is an L-aspartic acid salt.

[0610] In embodiments, the salt of Compound (I) is a phosphoric acid salt.

[0611] In embodiments, the salt of Compound (I) is a (+)-camphor-10-sulfonic acid salt.

[0612] In embodiments, the salt of Compound (I) is an L-glutamic acid salt.

[0613] In embodiments, the salt of Compound (I) is a malonic acid salt.

[0614] In embodiments, the salt of Compound (I) is a gentisic acid salt.

[0615] In embodiments, the salt of Compound (I) is a fumaric acid salt.

[0616] In embodiments, the salt of Compound (I) is a citric acid salt.

[0617] In embodiments, the salt of Compound (I) is a D-glucuronic acid salt.

[0618] In embodiments, the salt of Compound (I) is a glycolic acid salt.

[0619] In embodiments, the salt of Compound (I) is an L-malic acid salt.

[0620] In embodiments, the salt of Compound (I) is a hippuric acid salt.

[0621] In embodiments, the salt of Compound (I) is an L-gluconic acid salt.

[0622] In embodiments, the salt of Compound (I) is a DL-lactic acid salt.

[0623] In embodiments, the salt of Compound (I) is an L-ascorbic acid salt.

[0624] In embodiments, the salt of Compound (I) is a benzoic acid.

[0625] In embodiments, the salt of Compound (I) is a succinic acid salt.

[0626] In embodiments, the salt of Compound (I) is an adipic acid salt.

[0627] In embodiments, the salt of Compound (I) is an acetic acid salt. Methods of Treatment

[0628] In aspects, the present disclosure provides methods of treating or preventing a disease or disorder comprising administering to a subject a Compound (I) HCl salt.

[0629] In embodiments, the Compound (I) HCl salt is HCl salt Form A.

[0630] In embodiments, the present disclosure provides methods of treating or preventing a disease or disorder in a subject in need thereof by administering to the subject a Compound (I) HCL salt, a composition comprising the same, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with a muscarinic antagonist, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0631] In embodiments, the Compound (I) HCl salt is HCl salt Form B.

[0632] In aspects, the present disclosure provides methods of treating or preventing a disease or disorder comprising administering to a subject a solid form of Compound (I) tartrate salt.

[0633] In embodiments, the Compound (I) tartrate salt is tartrate salt Form A.

[0634] In embodiments, the Compound (I) tartrate salt is tartrate salt Form B.

[0635] In embodiments, the Compound (I) tartrate salt is tartrate salt Form C.

[0636] In embodiments, the Compound (I) tartrate salt is tartrate salt Form D.

[0637] In embodiments, the Compound (I) tartrate salt is tartrate salt Form E.

[0638] In embodiments, the Compound (I) tartrate salt is tartrate salt Form F.

[0639] In aspects, the present disclosure provides methods of treating or preventing a disease or disorder comprising administering to a subject hydrobromic acid salt, naphthalene-1,5-disulfonic acid salt, sulfuric acid salt, ethane-1,2-disulfonic acid salt, ethanesulfonic acid salt, 2- hydroxyethanesulfonic acid salt, p-toluenesulfonic acid salt, methanesulfonic acid salt, naphthalene-2-sulfonic acid salt, benzenesulfonic acid salt, maleic acid salt, L-aspartic acid salt, phosphoric acid salt, (+)-camphor-10-sulfonic acid salt, L-glutamic acid salt, malonic acid salt,gentisic acid salt, fumaric acid salt, citric acid salt, D-glucuronic acid salt, glycolic acid salt, L- malic acid salt, hippuric acid salt, L-gluconic acid salt, DL-lactic acid salt, L-ascorbic acid salt, benzoic acid, succinic acid salt, adipic acid salt, or acetic acid salt of Compound (I).

[0640] In embodiments, the salt of Compound (I) is a hydrobromic acid salt.

[0641] In embodiments, the salt of Compound (I) is a naphthalene-1,5-disulfonic acid salt.

[0642] In embodiments, the salt of Compound (I) is a sulfuric acid salt.

[0643] In embodiments, the salt of Compound (I) is an ethane-1,2-disulfonic acid salt.

[0644] In embodiments, the salt of Compound (I) is an ethanesulfonic acid salt.

[0645] In embodiments, the salt of Compound (I) is a 2-hydroxyethanesulfonic acid salt.

[0646] In embodiments, the salt of Compound (I) is a p-toluenesulfonic acid salt.

[0647] In embodiments, the salt of Compound (I) is a methanesulfonic acid salt.

[0648] In embodiments, the salt of Compound (I) is a naphthalene-2-sulfonic acid salt.

[0649] In embodiments, the salt of Compound (I) is a benzenesulfonic acid salt.

[0650] In embodiments, the salt of Compound (I) is a maleic acid salt.

[0651] In embodiments, the salt of Compound (I) is an L-aspartic acid salt.

[0652] In embodiments, the salt of Compound (I) is a phosphoric acid salt.

[0653] In embodiments, the salt of Compound (I) is a (+)-camphor-10-sulfonic acid salt.

[0654] In embodiments, the salt of Compound (I) is an L-glutamic acid salt.

[0655] In embodiments, the salt of Compound (I) is a malonic acid salt.

[0656] In embodiments, the salt of Compound (I) is a gentisic acid salt.

[0657] In embodiments, the salt of Compound (I) is a fumaric acid salt.

[0658] In embodiments, the salt of Compound (I) is a citric acid salt.

[0659] In embodiments, the salt of Compound (I) is a D-glucuronic acid salt.

[0660] In embodiments, the salt of Compound (I) is a glycolic acid salt.

[0661] In embodiments, the salt of Compound (I) is an L-malic acid salt.

[0662] In embodiments, the salt of Compound (I) is a hippuric acid salt.

[0663] In embodiments, the salt of Compound (I) is an L-gluconic acid salt.

[0664] In embodiments, the salt of Compound (I) is a DL-lactic acid salt.

[0665] In embodiments, the salt of Compound (I) is an L-ascorbic acid salt.

[0666] In embodiments, the salt of Compound (I) is a benzoic acid.

[0667] In embodiments, the salt of Compound (I) is a succinic acid salt.

[0668] In embodiments, the salt of Compound (I) is an adipic acid salt.

[0669] In embodiments, the salt of Compound (I) is an acetic acid salt.

[0670] In aspects, the present disclosure provides methods of treating or preventing a disease or disorder comprising administering to a subject 2-napthalenesulfonic acid salt, stearic acid salt, caprylic acid salt, 1-hydroxy-2-napthoic acid salt, decanoic acid salt, oleic acid salt, or benzoic acid salt of Compound (I).

[0671] In embodiments, the salt is 2-napthalenesulfonic acid salt.

[0672] In embodiments, the salt of Compound (I) is stearic acid salt.

[0673] In embodiments, the salt of Compound (I) is caprylic acid salt.

[0674] In embodiments, the salt of Compound (I) is 1-hydroxy-2-napthoic acid salt.

[0675] In embodiments, the salt of Compound (I) is decanoic acid salt.

[0676] In embodiments, the salt of Compound (I) is oleic acid salt.

[0677] In embodiments, the salt of Compound (I) is benzoic acid salt.

[0678] In embodiments, the disease or disorder is mediated by a muscarinic receptor.

[0679] In embodiments, the disease or disorder is a neurological disease or disorder with reduced peripheral cholinergic effects.

[0680] In embodiments, the neurological disease or disorder is schizophrenia. In some embodiments, the subject with schizophrenia is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) HCl salt is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with a muscarinic antagonist, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0681] In embodiments, the neurological disease or disorder is acute schizophrenia. In embodiments, the neurological disease or disorder is chronic schizophrenia. In embodiments, the patient is treated for cognitive impairment in schizophrenia. In some embodiments, the subject with acute schizophrenia, chronic schizophrenia, and / or cognitive impairment in schizophrenia is is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) HCl salt is in the Form A, the remainder being composed of the amorphous form or othercrystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with a muscarinic antagonist, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0682] In embodiments, the neurological disease or disorder is Alzheimer’s disease. The Alzheimer’s disease can be early-stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease. In some embodiments, the subject with Alzheimer’s disease is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with muscarinic antagonist, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0683] In embodiments, the neurological disease or disorder is acute Alzheimer’s disease. In some embodiments, the subject with acute Alzheimer’s disease is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) HCl salt is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with a muscarinic antagonist, preferably fesoterodine or salt thereof, more preferably fesoterodine fumarate.

[0684] In embodiments, the patient is treated for Alzheimer’s disease psychosis. In embodiments, the patient is treated for Alzheimer’s disease cognition. In embodiments, the treatment improves or maintains cognitive function in the Alzheimer’s disease patient. In some embodiments, the patient is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) HCl salt is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with a muscarinic antagonist agent, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0685] In embodiments, the neurological disease or disorder is a dyskinesia. In embodiments, the dyskinesia is levodopa-induced dyskinesia. In embodiments, the patient is diagnosed withParkinson’s disease. In embodiments, the dyskinesia is tardive dyskinesia. In some embodiments, the subject with dyskinesia, levodopa-induced dyskinesia, Parkinson’s disease, and / or tardive dyskinesia is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) HCl salt is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with a muscarinic antagonist, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0686] In embodiments, the neurological disease or disorder is a psychosis. In embodiments, the neurological disease or disorder is Parkinson’s disease psychosis, dementia-related psychosis, brief psychotic disorder, Lewy body disease with psychosis or acute delirium. In some embodiments, the subject with acute Alzheimer’s disease is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) HCl salt is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with a muscarinic antagonist, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0687] In embodiments, the present disclosure provides a method of treating agitation in Alzheimer’s disease dementia, Lewy body disease with psychosis, dementia with Lewy bodies, bipolar manic episodes, bipolar mixed episodes, bipolar maintenance (bipolar 1 and / or 2), bipolar depression, or cognitive impairment in bipolar 1 and / or 2 disorder. In some embodiments, the subject with agitation is administered a composition comprising the compound of Formula (I) HCl salt, wherein at least 90 wt.%, at least 95 wt.%, at least 97.5 wt.%, at or at least 99 wt.% of the compound of Formula (I) HCl salt is in the Form A, the remainder being composed of the amorphous form or other crystalline forms of the compound of Formula (1). In some embodiments, the compound of Formula (I) HCl salt Form A is administered in combination with muscarinic antagonist, preferably fesoterodine or a salt thereof, more preferably fesoterodine fumarate.

[0688] In embodiments, the present disclosure provides methods of treating the neurologicaldiseases or disorders as described in International Application No. PCT / US2022 / 080429, which is hereby incorporated by reference in its entirety for all purposes.

[0689] All percentages and ratios used herein, unless otherwise indicated, are by weight. Other features and advantages of the present application are apparent from the different examples. The provided examples illustrate different components and methodology useful in practicing the present application. The examples do not limit the claimed application. Based on the present application the skilled artisan can identify and employ other components and methodology useful for practicing the present application. EXAMPLES

[0690] The application is further illustrated by the following examples, which are not to be construed as limiting this application in scope or spirit to the specific procedures herein described. It is to be understood that the examples are provided to illustrate certain embodiments and that no limitation to the scope of the application is intended thereby. It is to be further understood that resort may be had to various other embodiments, modifications, and equivalents thereof which may suggest themselves to those skilled in the art without departing from the spirit of the present application and / or scope of the appended claims. Materials and Methods: X-ray Powder Diffraction (XRPD)

[0691] XRPD analysis was carried out on a PANalytical X’pert pro with PIXcel detector (128 mortar and pestle to release any agglomerates and loaded onto a multi-well plate with Mylar polymer film to support the sample. The multi-well plate was then placed into the diffractometer 40 mA generator settings. Data were visualized and images generated using the HighScore Plus 5.2 desktop application (PANalytical, 2023). Calibration is conducted monthly using alumina standard. Polarized Light Microscopy (PLM)

[0692] The presence of crystallinity (birefringence) was determined using an Olympus BX53 microscope, equipped with cross-polarizing lenses and a Motic camera. Images were capturedusing Motic Images Plus 3.0. All images were recorded using the 10×, 20× and 50× objectives. Calibration and service are conducted annually by external service contractors. Thermogravimetric Analysis / Differential Scanning Calorimetry (TGA / DSC)

[0693] Approximately 5-10 mg of material was added into a pre-tared open aluminum pan and loaded into a TA Instruments Discovery SDT 650 Auto - Simultaneous DSC and held at room temperature. The sample was then heated at a rate of 1 °C / min and 10 °C / min from 30 °C to 400 °C during which time the change in sample weight was recorded along with the heat flow response (DSC). Nitrogen was used as the sample purge gas, at a flow rate of 200 cm3 / min. Calibration is performed monthly using indium as the calibration standard. Differential Scanning Calorimetry (DSC)

[0694] Approximately 1-5 mg of material was weighed into an aluminum DSC pan and sealed non-hermetically with an aluminum lid. The sample pan was then loaded into a TA Instruments Discovery DSC 2500 differential scanning calorimeter equipped with RC90 cooler. The sample and reference were heated below the degradation temperature at a scan rate of 10 °C / min and the resulting heat flow response monitored. The sample was re-cooled to –80 °C and then reheated to the same temperature as in the first heat, all at 10 °C / min. Nitrogen was used as the purge gas, at a flow rate of 50 cm3 / min. Calibration is performed monthly using indium as the calibration standard. Karl Fischer Coulometric Titration (KF)

[0695] 10-15 mg of solid material was accurately weighed into a vial. The solid was then manually introduced into the titration cell of a Mettler Toledo C30 Compact Titrator. The vial was back weighed after the addition of the solid and the weight of the added solid entered on the instrument. Titration was initiated once the sample had fully dissolved in the cell. The water content was calculated automatically by the instrument as a percentage and the data printed. Infrared Spectroscopy (IR)

[0696] Infrared spectroscopy was carried out on a Bruker ALPHA P spectrometer. Sufficient material was placed onto the center of the plate of the spectrometer and the spectra were obtained using the following parameters:Nuclear Magnetic Resonance (NMR) Spectroscopy

[0697] NMR experiments were performed on a Bruker AVIIIHD spectrometer equipped with a DCH cryoprobe operating at 500.12 MHz for 1H. Experiments were performed in deuterated dimethyl sulfoxide and each sample was prepared to a ca.10 mM concentration. Dynamic Vapor Sorption (DVS)

[0698] Approximately 10-20 mg of sample was placed into a mesh vapor sorption balance pan and loaded into a DVS Advantage dynamic vapor sorption balance by Surface Measurement Systems. The sample was subjected to a ramping profile from 40 – 90% relative humidity (RH) at 10% increments, maintaining the sample at each step until a stable weight had been achieved (dm / dt 0.004%, minimum step length 30 minutes, maximum step length 500 minutes) at 25 °C. After completion of the sorption cycle, the sample was dried using the same procedure to 0% RH and then a second sorption cycle back to 40% RH. Two cycles were performed. The weight change during the sorption / desorption cycles were plotted, allowing for the hygroscopic nature of the sample to be determined. XRPD analysis was then carried out on any solid retained. Variable Temperature X-ray Powder Diffraction (VT-XRPD)

[0699] VT-XRPD analysis was carried out on a Philips X’Pert Pro Multipurpose diffractometer Bragg-Brentano geometry (step size Measurements were performed in the 25 to 170 °C range. Experiments were conducted under ambient humidity and nitrogen. Calibration is conducted monthly using alumina powder. High Performance Liquid Chromatography-Ultraviolet Detection (HPLC-UV)

[0700] Gradient program:Gas Chromatography Detection (GC)

[0701] Gradient program:Liquid chromatography with charged aerosol detection (LC-CAD) Method

[0702] Gradient Program:Water Activity Meter

[0703] Water activity measurements were performed on a validated AQUALab TDL Water Activity Monitor Series 4. Two measurements were taken per sample and an average taken of the two values. The instrument is calibrated before use. Solvents were dried with molecular sieves prior to use. Calculated water activity values were determined using the method described in Refs. 1 and 2.pH Meter

[0704] pH measurements were performed using a Mettler-Toledo Seven Excellence pH meter and a microprobe. The instrument was calibrated daily using a range of pH buffers.

[0705] Alternatively, the salt and solid form screening were performed by using the following instruments and methods. X-ray Powder Diffraction (XRPD)

[0706] XRPD was performed with a Panalytical Aeris Powder XRPD (CPNJ-E41) on a Si zero- The parameters used are listed below. Parameters Reflection Mode X-Ray wavelength X-Ray tube setting 45 kV, 40 mA Divergence slit Fixed 1 / 8° Scan mode Continuous Scan range (° 2TH) 3-40 Scan step time [s] 17.595 Step size (° 2TH) 0.0109 Test Time 4 min 30 s Thermogravimetric Analysis / Differential Scanning Calorimetry (TGA / DSC)

[0707] TGA data was collected using a TA Discovery 550 TGA from TA Instrument (CPNJ-E3). TGA was calibrated using a nickel reference standard. DSC was performed using a TA D2500 DSC from TA Instrument (CPNJ-E27). DSC was calibrated with an Indium reference standard. Detailed parameters used are listed below. Parameters TGA DSC Method Ramp Ramp Sample pan Platinum, open Aluminum Temperature RT - desired temperature 25 °C - desired temperatureHeating rate 10 °C / min 10 °C / min Purge gas N2N2Polarized Light Microscopy (PLM)

[0708] Polarized light microscopic picture was captured on Nikon DS-Fi2 upright microscope (CPNJ-E10) at room temperature. Dynamic Vapor Sorption (DVS)

[0709] DVS was measured via a SMS (Surface Measurement Systems) DVS Resolution (CPNJ- E44). The relative humidity at 25 ºC was calibrated against the deliquescence point of LiCl, Item Value Temperature 25 °C Sample size 10 – 20 mg Gas and flow rate N2, 200 mL / min dm / dt 0.002% / min Min. dm / dt stability duration 10 min Max. equilibrium time 180 min RH range Ambient % RH – 95% RH – 0% RH – 95% RH RH step size 10% HPLC method

[0710] The HPLC method conditions used for measuring solubilities are summarized the table below.EXAMPLE 1. Polymorphs of Compound (I) Hydrochloride Salt

[0711] The following example describes crystalline polymorphs of Compound (I) HCl salt, specifically Form A and Form B.

[0712] Preparation of Form A: DMSO (3.5 volumes by weight [v / w]) was added to a glass-lined reactor inerted with nitrogen. The compound of Formula (I) free base was charged (1 weight by weight equivalent [w / w]). The mixture was stirred and temperature was adjusted from 20 °C. to 60 °C. to ensure full dissolution. The solution was passed through a 45 μm filter into a receiving vessel heated to 60 °C. Temperature was decreased to 50 °C. and the mixture was aged for 2 hours. The slurry was then cooled to 25 °C over the course of at least 2 hours. Ethyl acetate (12.0 v / w) was charged over at least 8 hours. The slurry was further cooled to 0 °C. over 2 hours and then aged for at least 12 hours. The crystals were isolated by filtration and dried under vacuum at 50 °C.

[0713] Preparation of Form B: Compound of Formula (I) HCl Salt, Form A (100 mg or 200 mg) was combined with water:dioxane (50:50 v / v%) (10 ml for 100 mg sample, 20 mL for 200 mg sample) to fully dissolve the material. The resulting clear solutions were frozen and lyophilized in a freezer drier at -40 °C. overnight. The resulting material was dried overnight under vacuum at 40 °C. Form B was obtained at both scales.

[0714] Both Form A and Form B were of high purity (> 99% determined by GC) and had a chloride content equivalent to a 1:1 stoichiometry. Thermal studies revealed that both forms were anhydrous with a 0.04 and 0.06 eq water for Form A and Form B respectively. Form A had a slightly higher onset of degradation, 170 ºC compared with 150 ºC for Form B. DVS analysis showed that both forms deliquesce when exposed to high relative humidity (> 80 % RH), with Form B displaying a higher water uptake at 80 to 90 % RH compared with Form A (54 % vs 5 %). Form B also converted to Form A during the DVS experiment. Stability studies at accelerated aging conditions showed that both Form A and Form B were physically and chemically stable with no loss in purity or change in solid form at the three conditions tested (7 days at 25 °C. / 60% RH (open vial), 40 ºC. / 75 % RH (open vial), and 80 ºC. (closed vial)).

[0715] Thermodynamic solubility of the two forms in various pH buffers (1.2, 4.5 and 6.8) showed high solubilities above 100 mg / mL for both forms. Residual solids obtained at pH 1.2 matched Form A by XRPD, while a mixture of Form A and B was obtained at pH 4.5 and 6.8. Table 1. XRPD peak list of HCl salt Form ATable 2. XRPD peak list of HCl salt Form BCharacterization of Form B

[0716] Form B was analyzed by NMR spectroscopy, PLM, FT-IR spectroscopy, TG / DSC, DSC, -XRPD, CAD and GC.

[0717] The following results were obtained from the characterization of Form B: Form B was retained after drying at 40 °C. at reduced pressure overnight. By 1H NMR spectroscopy, no trace of solvent was detected. The spectrum of Form B is consistent with the HCl salt structure and NMR data of Form A. By PLM, irregular shaped particles of different sizes with birefringence were observed. The FT-IR analysis showed an IR spectrum in agreement with the proposed structure. TG / DSC analysis with a heating rate of 10 °C. / min showed a weight loss of 0.546 wt.% up to 150.4 °C. (0.06 eq. water vs. 0.04 eq. of water for Form A, likely related to moisture adsorbed to the surface), degradation / melt of the material occurred above 150 °C. The mass loss observed is consistent with an anhydrous material. A melt / degradation event with anonset of 220 °C. was observed in the DSC trace alongside material degradation. Using a heating rate of 1 °C. / min, a 0.43% initial mass loss (0.04 eq. of water) was observed with material degradation observed at 128 °C. alongside an endothermic event with an onset of 200 °C. In the standalone DSC experiment, the material was heated to 170 °C., cooled to –80 °C, then re-heated to 170 °C. No events were observed which indicated no form conversion had occurred. – the material was anhydrous. By DVS, no mass uptake was observed until above 80% RH. A 54 wt% mass uptake (13.14 water eq) was observed during the first sorption step between 80 and 90% RH indicating a hydration event or deliquescence. The mass profile showed that the experiment timed out on the 90% RH steps after 500 minutes, indicating that the material would continue to uptake water if allowed. A slight difference in the kinetic plots was observed between the two cycles, with the mass decrease taking longer in the first cycle suggesting a different moisture uptake mechanism was in place and that a form change may have occurred. After DVS analysis, the material had aggregated and taken the shape of the DVS sample holder (the material was a light fluffy powder beforehand), likely due to deliquescence followed by recrystallization. XRPD analysis after the DVS experiment confirmed that Form B had converted into Form A. By VT-XRPD, Form B was preserved throughout the experiment up to 170 °C., which was consistent with the data obtained by DSC. See Table 4 for summary of data. Table 4 - VT-XRPD program used for the analysis of the scaled-up Form BBy CAD, 19.5 w / w% of chloride was detected which is equivalent to a 1:1 stoichiometry with the API.By GC, Form B had a purity of 100% area. 7-Day Stability Studies

[0718] A 7-day stability study was carried out at three different conditions for Form A and Form B. The results of the 7-day stability study are displayed in Table 5 and summarized below: Table 5 - 7-Day stability study of Form A and Form BThermodynamic Solubility Studies

[0719] A thermodynamic solubility study was carried out with five aqueous media for Form A and Form B. The results of the thermodynamic solubility assessment shows that the crystalline form of each polymorph was only retained at pH 1.2 with a conversion into a mixture of Forms A and B at higher pH values of 4.5 and 6.8. Solubility results showed high solubility at all three pH values examined (>100 mg / mL).

[0720] The results of the thermodynamic solubility assessment are displayed in the Table 6 below. Table 6. Thermodynamic solubility assessment of Form A and Form B.* indicates Preferred Orientation ** indicates Pattern Shift 5.6 Polymorph Stability Studies

[0721] Polymorph stability studies allow for identification of the most stable form in selected solvent systems. This is achieved by mixing two solid forms, Form A and Form B, of the Compound (I) HCl salt in a saturated solution, and investigating which form is retained at the end of the experiment.

[0722] The results of the polymorph stability studies showed that Form A was prevalent in all solvent systems and temperatures investigated. In addition, these experiments showed that Form A is the more stable form in the solvent systems and conditions investigated.

[0723] The results of the polymorph stability studies are displayed in Table 7 below. Table 7. Polymorph stability studies on Form A and Form BEXAMPLE 2. Polymorphs of Compound (I) Tartrate Salt

[0724] Crystalline polymorphs of Compound (I) tartrate salt were prepared. Compound (1) free base (~7 g) was added to a vial and combined with 50 mL ethyl acetate and the solution was transferred to a 400 mL reactor equipped with overhead stirring. The vial was washed with a further 50 mL ethyl acetate and the washing added to the reactor. Tartaric acid (46.61 mL, 1.1 eq., 1 M in ethanol) was added to the reactor to form a mobile slurry. The resulting slurry was temperature cycled for 72 hours between 40 °C. and 5 °C. (0.1 °C. / min ramp) with isothermal holds at 40 °C. and 5 °C. for 1 hour. A sample of the slurry was taken and confirmed to be Form A, the remaining solid was isolated by Buchner filtration and dried under vacuum at 40 °C. overnight.

[0725] Compound (I) tartrate salt Form A prepared at the 7 g scale was used as input for the study.

[0726] For temperature cycling, tartrate salt Form A was added to an HPLC vial and combined Samples were temperature cycled between 40 °C. and 5 °C. at a heating / cooling rate of 0.1 °C / min with holds of 1 hour at 40 °C. and 5 °C. After cycling for 72 hours samples were isolated for XRPD analysis. In the case of solid samples, they were further dried overnight at 40 °C. under vacuum. Samples that were liquors were then subjected to cosolvent and antisolvent procedures.

[0727] For cosolvent experiments, the indicated solvents were added to the liquor until a cloudy at 40 °C. for 72 hours. Solids were isolated and dried overnight at 40 °C. under vacuum.

[0728] For antisolvent experiments, liquors were pipetted into HPLC vials and antisolvent was vials were manually shaken between each aliquot.

[0729] A total of 7 novel tartrate forms (Form A to From G) were identified. These were both tartrate mono- and hemi-salts. The most commonly observed form was Form A. Tartrate forms Aand C were mono- Forms B, D and E were hemi- Form F was only observedin a mixture with Form A. Form G was only obtained from wet material. Forms D and E had very similar XRPD diffractograms and other characterization data.

[0730] Overall, tartrate Form D (hemi-salt) is a form with good solid form properties. It has a lower molecular weight compared to the mono-salt, is non-hygroscopic and showed better formstability compared to Form C. Form A is also a form with good solid form properties. Solvent played an important role in the tartrate system, where water was the solvent, mono-salts were favored, and where DMSO, DMF, DMA and NMP were used as the solvent, the hemi salt was favored. Table 8. XRPD peak list of tartrate salt Form A from ethyl acetateTable 9. XRPD peak list of tartrate salt Form BTable 10. XRPD peak list of tartrate salt Form C from freeze dryingTable 11. XRPD peak list of tartrate salt Form D from temperature cycling DMATable 12. XRPD peak list of tartrate salt Form E from temperature cycling DMATable 13. XRPD peak list of tartrate salt Form F / A from antisolvent addition DMF / tBMETable 14. XRPD peak list of tartrate salt Form G from fast cooling, 80% acetone : 20% water (% v / v)Characterization of Tartaric Acid Salt Forms A-G

[0731] Seven novel tartrate forms were identified. Tartrate Form A was formed by adding Compound (I) free API and 1.1 equivalents of tartaric acid together in six different solvents, which all produced tartrate Form A. Tartrate Form B was prepared in ethyl acetate when Compound (I) free API and 0.55 equivalents of tartaric acid were added together. Tartrate Form A was an anhydrous mono-salt whilst Form B was an anhydrous hemi-salt. Of the other five novel tartrate forms observed, four of these novel hits were stable when drying and therefore were characterized by TG / DSC, NMR, PLM and IR. When a form was only observed when the material was wet (tartrate Form G), further characterization was not performed.

[0732] To try and conclude if Forms D and E were the same, both samples were stored at 40 °C / 75 % RH for ca.72 hours and then re-analyzed by XRPD to check for any differences in the XRPD diffractograms.

[0733] A summary of the characterization data obtained from the novel tartrate forms can be found in Table 16. For comparison, a summary of the characterization data obtained from of Forms A and B is also included.,iil iatadnoiitaziretcarah tlatc Sni)2B etgh 5 dden. .thingi3el1(pet.)s ep ci taioit )Cont onet Aimeh°apweisin N vnsesin c Tlmt,rrrr e dw - amn o t.on r 3f ll ios.noueed s l a eto nretotece s7iser uqiletustltt erie rstctHh t 1t g l e t osiuaa tbfh asaavr rusaeitieb be sora P ig p5ol a d m dt seu d tg iph e,si dotai 5 pa l ,ss y l e dem.l o Sr nlr A n n h inreht tM0aC ogg o e e s fwr T iw(on °tcee ev(aaCmT rwd eA NTrStratoe tsl 44 l7sta 8st7 ynotc ho) 10nl 1ohdn0 S g2 ( th ne h t stitee tiee oig i- Aee rghnpvsAnLeagn ope wemis wnn w5i icTpreor.r ea,t t.eo ttfclal . .d) upe s0 i (a ns rr) aMtm tec esqewuttetdriee tcts onTlme tl tli Ceaoas ave i re r u cso° .a orrbi cl lirPi0o ea ecS o at d,g tsb nv1Ms phl siie ao .yo o( tnleAwasg d d1t t ha ooidsbwTpna al , nld e aeCrirmTtgUttf neCfgAr S eo iren°efa huNdy T SramCGmSu y TsRriDs aD SMyMP.lmR6LINaR mn P1XuH / AC1 SelGS TDbaTForms D and E produced very similar XPRD diffractograms and other very similar characterization data. Compared to Form D, Form are also split peaks in Form E compared to Form D and Form E has a shoulder on the peak at ca.

[0734] One mono-salt (Form C) and one hemi-salt (Form D) were chosen for provide more information about the Compound (I) tartrate salt and its solid forms.

[0735] A summary of the characterization data collected for tartrate Form C can be found in Table 17. Table 17. Summary of characterization data of tartrate Form C

[0736] Overall, tartrate Form C was a slightly hygroscopic, anhydrous mono-salt. Conversion to Form A was observed during DVS analysis. This was confirmed by VH-XRPD where Form C converted to Form A at ambient humidity (see Table 18 below). An initial XRPD scan in transmission mode was completed which confirmed the input material for VH-XRPD analysis was Form C. However, the ca.10-15 minutes required to plate and analyze the material in the humidity chamber of the XRPD in reflectance mode showed small peaks of Form A already forming before the variable humidity program was started. Two XRPD measurements were taken at each %RH value of the variable VH program, once when the target %RH was initially reached and a second after ca.1 hour after the target %RH was reached. The exception to this was 0 %RH, which only reached 2 %RH, and was held for ca.17 hours (overnight) rather than just a 1-hour hold. A mixtureof Form A and Form C was observed until after 1 hour at 60 %RH. After this time, only Form A was observed. Table 18. VH-XRPD results of tartrate Form C.

[0737] A summary of the characterization data of Form D can be found in Table 20. Overall, tartrate Form D was an anhydrous hemi-salt which was non-hygroscopic. Tartrate Form D did not change form during DVS analysis, likely tartrate Form C. Table 20. Summary of characterization data of tartrate Form D.

[0738] In attempts to maximize yield, liquors from temperature cycling experiments 1 and 2 were retained for further experiments. For experiment 1 which used a solvent: antisolvent ratio of ca.1: 2.3 v / v, tartrate Form A was formed and not the desired Form D. No further analysis was performed. For experiment 2 which used a solvent: antisolvent ratio of ca.2.3: 1 v / v, the sample was hazy after ca.72 hours at 5 °C. An attempt was made to isolate any solid by Buchner filtration, however, no solid was collected. No further analysis was performed. This suggested that the ratio of solvent: antisolvent was important. Too little antisolvent would not cause precipitation. The excess tartaric acid present in the liquors due to the formation of the hemi-salt (Form D) from the mono-salt input (Form A) caused Form A precipitate out rather than the desired hemi-salt (Form D). Seven-day Stability

[0739] Seven-day stability tests on tartrate Forms C and D were performed to give an indication on chemical and physical stability after storage at forcing conditions. The results obtained for the 7-day stability studies are shown in Table 21. Table 21. Summary of results from seven-day stability studies.Thermodynamic Solubility

[0740] Thermodynamic solubility of tartrate Forms C and D was examined in three different pH buffers and water at 37 °C to determine solubility and form stability. The results are summarized in Table 22:X0- A0L e-LA MreFMrF42()sr 23948 833 4Huo .3.3 4.5.3 0.5 8. 940. 366.ph 5snono dede nononon itlu yritumgititi ou utit y lo ru lo mufil lulaa duslssu rt on sosonivr o ssetssg, e ssss sssl ye ece e eiF e l l l l lCs dhr r r r rnub o o o o oel l l l lWohlOo o o o oC w C C C C C dn n n n n n5es o o o o o otsri i i i i ikl t t t t t tyn coru u u u u u)fu o rel l l l l lissly ut ho o o o o odelae ds s s s s st cai esr ut r uvs s s s s sieos s s s s sr rH nl ty inie i e e e e eetptI l l l l l liCshsr r r r r rlmebio o o o o ocdl l l l l lWbOn o o o o o onu oaC C C C C Cl (oslca2 6 0 4 6 5 9 3iitH3 6 4 2 9 8 1 6i. . . . . . . .pm3 3 5 3 4 4 6 5na Iny e drd)eemo 0 0 0 0 0 0 0 0effLuf 0 0 0 0 0 0 0 0dolmμu 1 1 3 1 1 1 1 1do (rBeA Vht rr rf ee eo ft t2 5 8 2 5 8H . . . . . .fa a 1 4 6 1 4 6 py urW W Bame e etCl t t Dma apuur rmt tmpSr rmr rn a aoa o.I F F S T T22el.ob1 2 3 4 5 6 7 8aN TCompetitive Slurry Experiments

[0741] Competitive slurry experiments were performed to investigate which of tartrate Forms A and C was most stable at certain conditions / solvent systems. This was achieved by mixing two solid forms of the Compound (I) tartrate salt in a saturated solution, and investigating which form was retained at the end of the experiment. Additionally, tartrate Form D was investigated to confirm whether the hemi-salt would convert back to a mono-salt with a solvent system which would be likely to give a mono-salt.

[0742] A summary of the competitive slurry experiments results can be found in Table 24 below..stnte ianvrses stri etet o,lnoi,dru s sletet ege sgestetmI eshihih o tu ed sihih nanihii hrbW CeO W Wlosda raW W OrO W Wpxeemnuf oiyt )rlL0o oulμ 00400400 0 0 0 0 0304040404040030ruVo( 3ls Seevi rutittar )epepC°(52055205520552055205memocTmo :l )Ov / :lorlo:rftnS yhe nlorst vnata)tvenahna eta)vl evMulE %D(htW / vot-2to %e ehtaES% t % %%(etW / cyvxEo %%(%sA0 5 5e h08t5252e cr2 7 7 a Efo et CyDarrtma rrmra otomF TuFpmeun tetIAaar Str mrt.r r4aa oT2T Fel.o0b1 2 3 4 5 6 7 8 9a 1N TEXAMPLE 3. Salts of Compound (I)

[0743] General procedure: Salt break: Compound (1) HCl (5 g) was added to a 250 mL RBF and water (10 mL) was then added in 2 mL aliquots to produce a solution. Sodium carbonate (2.34 mg) was weighed into a 20 mL scintillation vial and water (20 mL) was added in 2 mL aliquots to produce a solution. The sodium carbonate solution was then added to the RBF. The mixture was stirred for 30 minutes using magnetic stirring. The water was removed using rotary evaporation and the resulting solid dried overnight under vacuum at 40 °C.

[0744] The resulting solid was combined with ethanol (550 mL) in a 1 L vessel set in a water bath set at 65 °C. To the resulting slurry was added HCl (15.72 mL, 1 M in ethanol) in aliquots (5 ml, 5 ml, 5 ml, 0.72ml). The slurry was stirred for 3.5 hours and then isolated by Buchner filtration using two fiber glass filter papers and a regular grade filter paper to increase trapped NaCl. The ethanol was removed by rotary evaporation and the resulting solid was dried overnight under vacuum at 40 °C.

[0745] The resulting solid was combined with ethanol (250 mL) in a 1 L vessel set in a water bath set at 65 °C. The slurry was stirred for 2 hours and then isolated by Buchner filtration using two fiber glass filter papers and a regular grade filter paper. The ethanol was removed by rotary evaporation and the resulting solid was dried for 72 hours under vacuum at room temperature to produce the compound of Formula (1) free base.

[0746] The following procedure was used for the primary salt screen: Approx 25 mg of free API was used for each experiment. For batch 1, a stock solution of the free API from was created in methanol: to 2.28 g of free API, 25.2 mL of methanol was adde mto produce a stock solution of -weighed HPLC vials. This targeted a free API mass of 25 mg per vial. These were uncapped and placed in a vacuum oven at 40 °C. under vacuum for approx.3 hours to remove the methanol. After drying, solvent was removed, and solids were left in the vials. These were then re-weighed with each vial containing 23-25 mg of solid. For batch 2, 25 mg of free API was weighed directly into HPLC vials.

[0747] 1, solvent was added until the solid had dissolved, or 1 mL of solvent was added. For batch 2, a solvent for a reaction to occur. Additional solvent was added when needed if a slurry instantly thickened on addition of thethe table below was added. Where possible, this was done using a 1 M stock solution of the acid in ethanol. If the acid was not miscible / soluble in ethanol, it was added neat. Addition of acids was performed at room temperature.

[0748] Samples were temperature cycled between 40 °C. and 5. °C at a heating / cooling rate of 0.1 °C. / min with holds of 1 hour at 40 °C. and 5 °C. Magnetic stirring was used throughout. After temperature cycling, observations were recorded.

[0749] To any colorless solutions or cloudy samples which would be difficult to retrieve solids added (maximum volume the vials could hold). For batch 1, antisolvent addition was conducted after approx. 48 hours of temperature cycling. Temperature cycling was then continued for an additional 24 hours so all samples were cycled for approx.72 hours in total. For batch 2, antisolvent addition was conducted after approx. 72 hours of temperature cycling Temperature cycling was then continued for an additional 24 hours for all samples which required antisolvent and therefore these samples were temperature cycled for approx.96 hours in total. Samples which did not require antisolvent from this batch were temperature cycled for approx.72 hours in total.

[0750] Slurries were isolated by centrifugation (nylon, 10000 rpm, 2 minutes, no filters). Any solutions were uncapped and evaporation allowed to occur in a water bath set to 40 °C. Solids were analyzed by XRPD when wet, after drying overnight at 40 °C under vacuum and after storage at 40 °C / 75%RH for approx.24 hours. Solvents used in salt preparationCounterions used in used in salt preparation.

[0751] Salts were identified in most of the acids assessed. Novel XRPD diffractogram patterns were observed for the salts, and in some cases, more than one pattern was observed per system, indicating that there was polymorphism across the salt systems. TGA / DSC and 1H NMR analysis showed that the novel diffractograms were indeed salts. Table 25. XRPD peak list of HBr salt Form A from ethanolTable 26. XRPD peak list of Naphthalene-1,5-disulfonic Acid Salt Form A from ethyl acetateTable 27. XRPD peak list of Naphthalene-1,5-disulfonic Acid Salt Form B from ethanol, 40 °C / 75 %RHTable 28. XRPD peak list of Naphthalene-1,5-disulfonic Acid Salt Form C from ethyl acetate, 40 °C / 75 %RHTable 29. XRPD peak list of Naphthalene-1,5-disulfonic Acid Salt Form D from THF, 40 °C / 75 %RHTable 30. XRPD peak list of Sulfuric acid Form A, toluene / heptaneTable 31. XRPD peak list of Sulfuric acid Form B, 2-ethoxyethanol / heptaneTable 32. XRPD peak list of Ethane-1,2-disulfonic Acid Salt Form A from ethanolTable 33. XRPD peak list of Ethanesulfonic Acid Salt Form A from toluene / heptaneTable 34. XRPD peak list of Ethanesulfonic Acid Salt Form B from IPA:water / heptane (95%:5%), 40 °C / 75 %RHTable 35. XRPD peak list of Ethanesulfonic Acid Salt Form C from 2-ethoxyethanol / heptaneTable 36. XRPD peak list of 2-Hydroxyethanesulfonic Acid Salt Form A from IPA:water (95%:5%) / heptaneTable 37. XRPD peak list of p-Toluenesulfonic Acid Salt Form A from ethyl acetateTable 38. XRPD peak list of p-Toluenesulfonic Acid Salt Form B from tolueneTable 39. XRPD peak list of p-Toluenesulfonic Acid Salt Form C from THF, 40 °C / 75 %RHTable 40. XRPD peak list of p-Toluenesulfonic Acid Salt Form D from toluene, 40 °C / 75 %RHTable 41. XRPD peak list of methanesulfonic Acid Salt Form A from 2-ethoxyethanol / heptaneTable 42. XRPD peak list of Naphthalene-2-sulfonic Acid Salt Form A from ethanolTable 43. XRPD peak list of benzenesulfonic Acid Salt Form A from ethyl acetateTable 44. XRPD peak list of benzenesulfonic Acid Salt Form B from IPA:water (95%:5%), 40 °C / 75 %RHTable 45. XRPD peak list of benzenesulfonic Acid Salt Form C from ethyl acetate, 40 °C / 75 %RHTable 46. XRPD peak list of maleic Acid Salt Form A from IPA:water (95%:5%), 40 °C / 75 %RHTable 47. XRPD peak list of maleic Acid Salt Form B from ethanol / heptaneTable 48. XRPD peak list of maleic Acid Salt Form C from THFTable 49. XRPD peak list of maleic Acid Salt Form D from ethyl acetate, 40 °C / 75 %RHTable 50. XRPD peak list of maleic Acid Salt Form E from IPA:water (95%:5%)Table 51. XRPD peak list of Aspartic acid pattern A / Free acid, from ethyl acetateTable 52. XRPD peak list of Aspartic Acid Salt Form A / B / Free acid, from tolueneTable 53. XRPD peak list of phosphoric Acid Salt Form A, from ethanolTable 54. XRPD peak list of phosphoric Acid Salt Form B, from THF, 40 °C / 75%RHTable 55. XRPD peak list of phosphoric Acid Salt Form C, from IPA:water (95%:5%), additional dryingTable 56. XRPD peak list of (+)-Camphor-10-sulfonic Acid Salt Form A from THF / heptaneTable 57. XRPD peak list of L-Glutamic acid Form A / Free acid, from THFTable 58. XRPD peak list of L-Glutamic acid Form B / Free acid, from IPA:water (95%:5%)Table 59. XRPD peak list of Malonic Acid Salt Form A from THF / heptaneTable 60. XRPD peak list of Fumaric Acid Salt Form A from 2-ethoxyethanolTable 61. XRPD peak list of Fumaric Acid Salt Form B from THFTable 62. XRPD peak list of D-Glucuronic Acid Salt Form A from 2-ethoxyethanolTable 63. XRPD peak list of Glycolic Acid Salt Form A from toluene / heptaneTable 64. XRPD peak list of L-Malic Acid Salt Form A from THFTable 65. XRPD peak list of L-Malic Acid Salt Form B from ethanolTable 66. XRPD peak list of L-Malic Acid Salt Form C from ethyl acetateTable 67. XRPD peak list of Hippuric Acid Salt Form A from tolueneTable 68. XRPD peak list of Hippuric Acid Salt Form B from ethanol / heptaneTable 69. XRPD peak list of Hippuric Acid Salt Form C from tolueneTable 70. XRPD peak list of Hippuric Acid Salt Form D from ethanol / heptaneTable 71. XRPD peak list of Hippuric Acid Salt Form E from IPA:water (95:5 %v / v) / heptaneTable 72. XRPD peak list of Hippuric Acid Salt Form F from 2-ethoxyethanol / heptaneTable 73. XRPD peak list of L-Ascorbic salt Form A from THF / heptane – poorly crystallineTable 74. XRPD peak list of succinic Acid Salt Form A from THFTable 75. XRPD peak list of adipic Acid Salt Form A from ethyl acetateTable 76. XRPD peak list of acetic Acid Salt Form A from ethyl acetate / heptaneTable 77. XRPD peak list of acetic Acid Salt Form B from THF / heptaneTable 78. XRPD peak list of acetic Acid Salt Form C from THF / heptaneEXAMPLE 4. Salts of Compound (I) (Bulky Counterions)

[0752] Salts of Compound (I) using bulky counterions were prepared. The starting material is a crystalline Compound (I) HCl salt. It is an anhydrous crystalline solid with a melting point ofSalt Breaking Experiment and Free Base Characterization

[0753] The salt breaking experiment was performed by addition of sodium carbonate to the HCl salt solution until the pH increased to 9. The resulting free base was isolated by recrystallizationfrom ethanol. The free base obtained was a crystalline solid with 8.8

[0754] 1 g of HCl salt and 466.8 mg Na2CO3 were dissolved in water to obtain a solution of pH ~9. The solution was concentrated under reduced pressure at 40 (using a rotary evaporator) to obtain a solid residue. 100 mL ethanol was then added to the solid at 65 . in a water bath and stirred for at least 5 min while the temperature was maintained at 65 was filtered hot to collect the filtrate, which was then concentrated under vacuum at RT to collect the free base solid. The free base solid was a slightly viscous, white solid. The solid was able to be partitioned, weighed and directly used for salt screening experiments.

[0755] The free base was determined to be highly hygroscopic and deliquescent by dynamic vapor sorption (DVS), showing a 52.0% water uptake at 80% relative humidity. The post-DVS deliquesced liquid was dried and converted back to the original crystalline phase of the free base. Both the free base and the HCl salt were analyzed by proton NMR to confirm that the free base form was indeed produced. The 24 hours kinetic solubility of the free base in water and in FaSSIF was measured by a Pion MicroDISS instrument and determined to be 55.9 and 73.3 mg / mL, respectively. The equilibrium solubility of the free base could not be reliably determined due to its deliquescent nature. The lower value observed by kinetic solubility experiments could be due to the phase separation occurring in the MicroDISS instrument, despite constant stirring. Salt Preparation Experiments

[0756] 20 mg of the free base and a corresponding molar ratio of salt former (1:1) were added separately in the selected solvents to form either a clear solution or a suspension. Then, the solution or suspension was stirred for at least 24 hours before being transferred to slow evaporation at RT until solid was obtained.

[0757] Salt preparation experiments were conducted using 17 counter-ions in varying stoichiometric ratios and five solvents (MeOH, H2O, EtOH / H2O (1:1), THF / H2O (1:1), ACN / H2O (1:1)), totaling 85 experiments including five blanks. The 17 counter-ions containing bulky hydrophobic groups were chosen to decrease the solubility of the salt. Since the free base showed relatively high approximate solubilities in MeOH and H2O (both larger than 40 mg / mL), these two solvents along with 3 other combinations of solvents containing 50% of H2O were chosen forreaction crystallization. Seven potential salt hits were observed from the salt preparation. The characterization results are summarized in Table 79. Table 79. Summary of Salt Preparation Hits2-Napthalenesulfonic Acid Salt

[0758] 2-Napthalenesulfonic Acid Salt (6036691-13-A6) was observed from reactive crystallization with 2-napthalenesulfonic acid (1:1) in methanol. The XRPD pattern is shown in FIG. 64A. TGA showed a negligible weight loss up to 176.2 and the DSC thermogram exhibited a melting endotherm at an onset of 183.5 (FIG.64B). Based on the thermal analysis data, this sample was determined to be anhydrous. The approximate solubility in water was estimated to be 86.4<S<100.8 mg / mL. Stearic Acid Salt

[0759] Stearic Acid Salt was observed from reactive crystallization with stearic acid (1:1) in methanol. The XRPD pattern shown in FIG. 65A. TGA showed a negligible weight loss up to(peak), followed by two overlapping endotherms at 79.6 (peak) and 84.7 (peak) (FIG.65B). Caprylic Acid Salt

[0760] Caprylic Acid Salt was observed from reactive crystallization with caprylic acid (1:2) in ACN / H2O (1:1, v / v). The XRPD pattern shown in FIG.66A. TGA showed a 0.94% weight loss ., before decomposition. The DSC thermogram exhibited a small endotherm at 92.6 (peak), followed by a very broad endotherm that accompanied the decomposition (FIG. 66B 1:0.19. 1-Hydroxy-2-Napthoic Acid Salt

[0761] 1-Hydroxy-2-Napthoic Acid Salt was observed from reactive crystallization with 1- hydroxy-2-napthoic acid (1:2) in H2O. The XRPD pattern shown in FIG. 67A. TGA showed a ., before decomposition. The DSC thermogram exhibited a broad desolvation endotherm at 83.6 (onset) attributable to a dehydration event, followed by two adjacent endotherms at 149.9 and 157.2 that accompanied the decomposition (FIG.67B). Therefore, this form was proposed to be a hemi-hydrate. Decanoic Acid Salt

[0762] Decanoic Acid Salt was observed from reactive crystallization with decanoic acid (1:2) in THF / H2O (1:1, v / v). The XRPD pattern shown FIG. 68A. TGA analysis showed a negligible ., before decomposition. The DSC thermogram exhibited an endotherm at 36.5 (peak), followed by two smaller endotherms at 64.3 and 79.9 (FIG.68B analysis showed 1.1% water content. Oleic Acid Salt

[0763] Oleic Acid Salt was observed from reactive crystallization with oleic acid (1:1) in ACN / H2O (1:1, v / v). The XRPD pattern shown in FIG. 69A, indicating relatively low crystallinity. TGA analysis results showed a 24.6% weight loss up to 158.9 that could be related to solvent loss or the loss of oleic acid (melting point ~14 endotherms at 46.1 ., 79.1 and 112.3 (peak) potentially due to large solvent loss. (FIG. 69BBenzoic Acid Salt

[0764] Benzoic Acid Salt was observed from reactive crystallization with benzoic acid (1:1) in THF / H2O (1:1). The XRPD pattern shown in FIG.70A indicated that the Benzoate Salt and pure benzoic acid showed overlapping diffraction signals located at approximately 8.1°, 16.3° and 32.9°. The other signals from the Benzoate Salt were not observed on the patterns of benzoic acid or the free base. TGA a thermogram exhibited a broad endotherm at 103.4 (peak), followed by two endotherms at 195.5 and 216.4 while the sample was decomposing (FIG.70B). ADDITIONAL EMBODIMENTS 1. A crystalline form of hydrochloride salt of a compound of Formula (I):wherein the crystalline form is selected from: Form A, wherein the Form A is characterized by having X-ray powder diffraction peaks at 19.28 ± 0.2, 21.53 ± 0.2, and 22.84 ± 0.2 radiation, and Form B, wherein the Form B is characterized by having X-ray powder diffraction peaks at 18.95 ± 0.2, 20.70 ± 0.2, and 21.49 ± 0.2 radiation. 2. The crystalline form of embodiment 1, wherein the crystalline form is Form A. 3. The crystalline form of embodiment 2, wherein the Form A is characterized by having X- ray powder diffraction peaks at 17.52 ± 0.2, 19.28 ± 0.2, 21.53 ± 0.2, 22.84 ± 0.2, and 32.46 ± 0.2 radiation. 4. The crystalline form of embodiment 2, wherein the X-ray powder diffraction pattern of Form A is substantially the same to that set forth in Fig.1A.5. The crystalline form of any one of embodiments 2-4, wherein the Form A is characterizedby an endothermic event with an onset temperature at 221 ± 2.0 °C as measured by DSC.6. The crystalline form of any one of embodiments 2-4, wherein the Form A is characterizedby an endothermic event with a peak temperature at 224 ± 2.0 °C as measured by DSC.7. The crystalline form of any one of embodiments 2-4, wherein the Form A is characterizedby a DSC thermogram substantially the same to that set forth in Fig.1B.8. The crystalline form of embodiment 1, wherein the crystalline form is Form B.9. The crystalline form of embodiment 8, wherein the Form B is characterized by having X-ray powder diffraction peaks at 18.95 ± 0.2, 20.70 ± 0.2, 21.49 ± 0.2, 22.69 ± 0.2, and 23.40 ± 0.2 radiation.10. The crystalline form of embodiment 8, wherein the X-ray powder diffraction pattern ofForm B is substantially the same to that set forth in Fig.2A.11. The crystalline form of any one of embodiments 8-10, wherein the Form B is characterizedby an endothermic event with an onset temperature at 220 ± 2.0 °C as measured by DSC.12. The crystalline form of any one of embodiments 8-10, wherein the Form B is characterizedby an endothermic event with a peak temperature at 223 ± 2.0 °C as measured by DSC.13. The crystalline form of any one of embodiments 8-10, wherein the Form B is characterizedby a DSC thermogram substantially the same to that set forth in Fig.2B.14. A crystalline form of tartaric salt of a compound of Formula (I):wherein the crystalline form is selected from: Form A, wherein the Form A is characterized by having X-ray powder diffraction peaks at 16.22 ± 0.2, 18.34 ± 0.2, and 26.08 ± 0.2 radiation, Form B, wherein the Form B is characterized by having X-ray powder diffraction peaks at 12.72 ± 0.2, 16.05 ± 0.2, and 20.02 ± 0.2 radiation, Form C, wherein the Form C is characterized by having X-ray powder diffraction peaks at 13.76 ± 0.2, 18.08 ± 0.2, and 19.85 ± 0.2 radiation, Form D, wherein the Form D is characterized by having X-ray powder diffraction peaks at 16.04 ± 0.2, 19.85 ± 0.2, and 20.02 ± 0.2 radiation, Form E, wherein the Form E is characterized by having X-ray powder diffraction peaks at 15.94 ± 0.2, 19.88 ± 0.2, and 20.02 ± 0.2 radiation, Form F, wherein the Form F is characterized by having X-ray powder diffraction peaks at 16.16 ± 0.2, 19.26 ± 0.2, and 25.94 ± 0.2 radiation, and Form G, wherein the Form G is characterized by having X-ray powder diffraction peaks at 19.12 ± 0.2, 22.63 ± 0.2, and 27.79 ± 0.2 radiation.15. The crystalline form of embodiment 14, wherein the crystalline form is Form A.16. The crystalline form of embodiment 15, wherein the Form A is characterized by having X-ray powder diffraction peaks at 16.22 ± 0.2, 17.81 ± 0.2, 18.34 ± 0.2, 19.29 ± 0.2, and 26.08 ± 0.2 radiation.17. The crystalline form of embodiment 15, wherein the X-ray powder diffraction pattern ofForm A is substantially the same to that set forth in Fig.3A.18. The crystalline form of any one of embodiments 15-17, wherein the Form A ischaracterized by an endothermic event with an onset temperature at 180 ± 2.0 °C as measured by DSC.19. The crystalline form of any one of embodiments 15-17, wherein the Form A ischaracterized by an endothermic event with a peak temperature at 186 ± 2.0 °C as measured by DSC.20. The crystalline form of any one of embodiments 15-17, wherein the Form A ischaracterized by a DSC thermogram substantially the same to that set forth in Fig.3B.21. The crystalline form of embodiment 14, wherein the crystalline form is Form B.22. The crystalline form of embodiment 21, wherein the Form B is characterized by having X-ray powder diffraction peaks at 12.72 ± 0.2, 13.98 ± 0.2, 16.05 ± 0.2, 19.86 ± 0.2, and 20.02 ± 0.2 radiation.23. The crystalline form of embodiment 21, wherein the X-ray powder diffraction pattern ofForm B is substantially the same to that set forth in Fig.4A.24. The crystalline form of embodiment 14, wherein the crystalline form is Form C.25. The crystalline form of embodiment 24, wherein the Form C is characterized by having X-ray powder diffraction peaks at 5.75 ± 0.2, 13.76 ± 0.2, 18.08 ± 0.2, 18.79 ± 0.2, and 19.85 ± 0.2 radiation.26. The crystalline form of embodiment 24, wherein the X-ray powder diffraction pattern ofForm C is substantially the same to that set forth in Fig.5A.27. The crystalline form of any one of embodiments 24-26, wherein the Form C ischaracterized by an endothermic event with an onset temperature at 180 ± 2.0 °C as measured by DSC.28. The crystalline form of any one of embodiments 24-26, wherein the Form C ischaracterized by an endothermic event with a peak temperature at 185 ± 2.0 °C as measured by DSC.29. The crystalline form of any one of embodiments 24-26, wherein the Form C ischaracterized by a DSC thermogram substantially the same to that set forth in Fig.5B.30. The crystalline form of embodiment 14, wherein the crystalline form is Form D.31. The crystalline form of embodiment 30, wherein the Form D is characterized by having X-ray powder diffraction peaks at 12.65 ± 0.2, 14.02 ± 0.2, 16.04 ± 0.2, 19.85 ± 0.2, and 20.02 ± 0.2 radiation.32. The crystalline form of embodiment 30, wherein the X-ray powder diffraction pattern ofForm D is substantially the same to that set forth in Fig.6A.33. The crystalline form of any one of embodiments 30-32, wherein the Form D ischaracterized by an endothermic event with an onset temperature at 175 ± 2.0 °C as measured by DSC.34. The crystalline form of any one of embodiments 30-32, wherein the Form D ischaracterized by an endothermic event with a peak temperature at 184 ± 2.0 °C as measured by DSC.35. The crystalline form of any one of embodiments 30-32, wherein the Form D ischaracterized by a DSC thermogram substantially the same to that set forth in Fig.6B.36. The crystalline form of embodiment 14, wherein the crystalline form is Form E.37. The crystalline form of embodiment 36, wherein the Form E is characterized by having X-ray powder diffraction peaks at 13.86 ± 0.2, 15.94 ± 0.2, 16.05 ± 0.2, 19.88 ± 0.2, and 20.02 ± 0.2 radiation.38. The crystalline form of embodiment 36, wherein the X-ray powder diffraction pattern ofForm E is substantially the same to that set forth in Fig.7A.39. The crystalline form of any one of embodiments 36-38, wherein the Form E ischaracterized by an endothermic event with an onset temperature at 170 ± 2.0 °C as measured by DSC.40. The crystalline form of any one of embodiments 36-38, wherein the Form E ischaracterized by an endothermic event with a peak temperature at 181 ± 2.0 °C as measured by DSC.41. The crystalline form of any one of embodiments 36-38, wherein the Form E ischaracterized by a DSC thermogram substantially the same to that set forth in Fig.7B.42. The crystalline form of embodiment 14, wherein the crystalline form is Form F.43. The crystalline form of embodiment 42, wherein the Form F is characterized by having X-ray powder diffraction peaks at 16.16 ± 0.2, 17.78 ± 0.2, 18.27 ± 0.2, 19.26 ± 0.2, and 25.94 ± 0.2 radiation.44. The crystalline form of embodiment 42, wherein the X-ray powder diffraction pattern ofForm F is substantially the same to that set forth in Fig.8A.45. The crystalline form of embodiment 1, wherein the crystalline form is Form G.46. The crystalline form of embodiment 45, wherein the Form G is characterized by having X- ray powder diffraction peaks at 19.12 ± 0.2, 22.63 ± 0.2, 24.31 ± 0.2, 27.04 ± 0.2, and 27.79 ± 0.2 radiation. 47. The crystalline form of embodiment 45, wherein the X-ray powder diffraction pattern of Form G is substantially the same to that set forth in Fig.9A. 48. A pharmaceutical composition comprising the crystalline form of any one of embodiments 1-47 and a pharmaceutically acceptable carrier or excipient. 49. A method of treating or preventing a neurological disease or disorder with reduced peripheral cholinergic effects, comprising administering to a subject in need thereof the crystalline form of any one of embodiments 1-47 or the pharmaceutical composition of embodiment 48. 50. The method of embodiment 49, wherein the neurological disease or disorder with reduced peripheral cholinergic effects is schizophrenia or Alzheimer’s disease psychosis, or dyskinesia. 51. A method of treating agitation in Alzheimer’s disease dementia, Lewy body disease with psychosis, dementia with Lewy bodies, bipolar manic episodes, bipolar mixed episodes, bipolar maintenance (bipolar 1 and / or 2), bipolar depression, or cognitive impairment in bipolar 1 and / or 2 disorder, comprising administering to a subject in need thereof the crystalline form of any one of embodiments 1-47 or the pharmaceutical composition of embodiment 48.

Claims

CLAIMS WHAT CLAIMED IS:

1. A crystalline salt of the compound of Formula (I):wherein the salt is Form A HCl salt characterized by X-ray powder diffraction peaks at radiation.

2. The crystalline form of claim 1, wherein the Form A HCl salt is characterized by X-raypowder diffraction peaks at 19.29 ± 0.2, 22.84 ± 0.2, 21.53 ± 0.2, 17.52 ± 0.2, 32.46 ± radiation.

3. The crystalline form of claim 1 wherein Form A HCl salt is characterized by X-raypowder diffraction peaks at 19.29 ± 0.2, 22.84 ± 0.2, 21.53 ± 0.2, 17.52 ± 0.2, 32.46 ± radiation.

4. The crystalline form of claim 1 wherein Form A HCl salt is characterized by X-raypowder diffraction substantially the same as set forth in Figure 3A.

5. The crystalline form of any of claims 1-4, wherein the crystalline salt is at least 90 wt.%,at least 95 wt.%, at least 97.5 wt.%, or at least 99 wt.% Form A HCl salt, the remainder being the amorphous form or other crystalline forms of the compound of Formula (1) HCl salt.

6. A crystalline salt of the compound of Formula (I):wherein the salt is Form B HCl salt characterized by X-ray powder diffraction peaks at7. The crystalline form of claim 6, wherein the Form B HCl salt is characterized by X-raypowder diffraction peaks at 20.70 ± 0.2, 18.95 ± 0.2, 21.49 ± 0.2, 22.70 ± 0.2, 23.40 ± radiation.

8. The crystalline form of claim 6 wherein Form B HCl salt is characterized by X-raypowder diffraction peaks at 20.70 ± 0.2, 18.95 ± 0.2, 21.49 ± 0.2, 22.70 ± 0.2, 23.40 ± radiation.

9. The crystalline form of claim 1 wherein Form B HCl salt is characterized by X-raypowder diffraction substantially the same as set forth in Figure 2A.

10. The crystalline form of any of claims 6-9, wherein the crystalline salt is at least 90 wt.%,at least 95 wt.%, at least 97.5 wt.%, or at least 99 wt.% Form B HCl salt, the remainder being the amorphous form or other crystalline forms of the compound of Formula (1) HCl salt.

11. A pharmaceutical composition comprising the crystalline form of any of claims 1-10.

12. The pharmaceutical composition of claim 11, further comprising an additionaltherapeutic agent.

13. The pharmaceutical composition of claim 12, wherein the additional therapeutic agentcomprises an antipsychotic, a cholinesterase inhibitor, a muscarinic antagonist, or a combination thereof.

14. The pharmaceutical composition of claim 12, wherein the additional therapeutic agentcomprises amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, chlorpromazine, clozapine, fluphaenazine, haloperidol, iloperidone, lumateperone, lurasidone, olanzapine, paliperidone, perphenazine, quetiapine, risperidone, thioridazine, thiothixene, trifluoperazine, xanomeline, ziprasidone donepezil, galantamine, rivastigmine, memantine, atropine, hyoscyamine, fesoterodine, hyoscine, ipratropium, tropicamide, cyclopentolate, pirenzepine, scopolamine, a salt thereof, or a combination thereof.

15. The pharmaceutical composition of claim 12, wherein the additional agent comprisesfesoterodine fumarate.

16. A method of treating a neurological disease or disorder in a subject in need thereof,comprising administering to the subject the crystalline salt of any of claims 1-10, or the pharmaceutical composition according to any of claims 11-15.

17. The method of claim 16, wherein the neurological disease or disorder is characterized byreduced peripheral cholinergic effects.

18. The method of claim 16, wherein the neurological disease or disorder is selected fromschizophrenia or Alzheimer’s disease.

19. The method of any of claims 16-18, further comprising administering to the subject oneor more additional therapeutic agents.

20. The method of claim 19, further comprising administering to the subject an antipsychotic,a cholinesterase inhibitor, a muscarinic antagonist, or a combination thereof.

21. The method of claim 19 or 20, comprising administering to the subject amisulpride,aripiprazole, asenapine, brexpiprazole, cariprazine, chlorpromazine, clozapine, fluphaenazine, haloperidol, iloperidone, lumateperone, lurasidone, olanzapine, paliperidone, perphenazine, quetiapine, risperidone, thioridazine, thiothixene, trifluoperazine, xanomeline, ziprasidone, donepezil, galantamine, rivastigmine, memantine, atropine, hyoscyamine, fesoterodine, hyoscine, ipratropium, tropicamide, cyclopentolate, pirenzepine, scopolamine, a salt thereof, or a combination thereof.

22. The method of claim 21, wherein the additional therapeutic agent comprises fesoterodineor a salt thereof.

23. The method of claim 21, wherein the additional therapeutic agent consists of fesoterodineor a salt thereof.

24. The method of claim 21, wherein the additional therapeutic agent comprises fesoterodinefumarate.

25. The method of claim 21, wherein the additional therapeutic agent consists of fesoterodinefumarate.

26. A salt of the compound of Formula (I):wherein the salt is a tartaric acid salt, hydrobromic acid salt, naphthalene-1,5-disulfonic acid salt, sulfuric acid salt, ethane-1,2-disulfonic acid salt, ethanesulfonic acid salt, 2- hydroxyethanesulfonic acid salt, p-toluenesulfonic acid salt, methanesulfonic acid salt,naphthalene-2-sulfonic acid salt, benzenesulfonic acid salt, maleic acid salt, L-aspartic acid salt, phosphoric acid salt, (+)-camphor-10-sulfonic acid salt, L-glutamic acid salt, malonic acid salt, gentisic acid salt, fumaric acid salt, citric acid salt, D-glucuronic acid salt, glycolic acid salt, L-malic acid salt, hippuric acid salt, L-gluconic acid salt, DL- lactic acid salt, L-ascorbic acid salt, benzoic acid, succinic acid salt, adipic acid salt, and acetic acid salt, 2-napthalenesulfonic acid salt, stearic acid salt, caprylic acid salt, 1- hydroxy-2-napthoic acid salt, decanoic acid salt, oleic acid salt, or benzoic acid salt27. The salt of claim 26, wherein the salt is a crystalline salt.

28. A pharmaceutical composition, comprising the salt of claim 26 or 27.

29. A method of treating a neurological disease or disorder in a subject in need thereof,comprising administering to the subject the salt of claim 26 or 27.

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