Patent classifications
A61K9/0029
Stable, highly pure L-cysteine compositions for injection and methods of use
The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O.sub.2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Material for the treatment of gastro-intestinal disorders
Provided herein is a bulk composition comprising the trihydrate form of (3S, 4R, 3′R)-6-[4-(4-amino-5-chloro-2-methoxy-benzoylamino)-3-methoxy-piperidin-1-yl]-hexanoic acid 1-azabicyclo[2.2.2]oct-3′-yl ester di-hydrochloride salt. Provided are also pharmaceutical compositions and dosage forms comprising the trihydrate form, and methods and uses for treating a gastrointestinal disorder in a subject with the trihydrate form. In some embodiments, the gastrointestinal disorder is gastroesophageal reflux disease (GERD), dyspepsia (such as functional dyspepsia or functional motility disorder), gastroparesis, paralytic ileus, post-operative ileus, emesis, nausea, heartburn, intestinal pseudo-obstruction, irritable bowel syndrome (IBS), constipation, enteral feeding intolerance (EFI), or esophagitis. In some embodiments, the gastrointestinal disorder is post-operative ileus, chronic grass sickness, constipation, megacolon, gastritis, gastrointestinal stasis, or abomasal emptying defect.
STABLE READY-TO-USE CARMUSTINE PHARMACEUTICAL COMPOSITION
The present invention relates to a ready-to-use solution of carmustine that does not require dissolution or dilution of the carmustine prior to addition to saline and dextrose parenteral solutions. In particular, the invention relates to a stable liquid pharmaceutical composition containing carmustine in the form of ready-to-use solution and method for preparing the same.
Very-long-chain polyunsaturated fatty acids, elovanoid hydroxylated derivatives, and methods of use
Provided are compounds, pharmaceutical compositions, cosmetic and dermatological compositions or nutritional supplement compositions, comprising omega-3 very-long-chain polyunsaturated fatty acids (n-3 VLC-PUFAs) and/or their endogenous hydroxylated derivatives thereof, known as elovanoids. This disclosure provides methods for neuroprotection, organ and tissue protection or restoration, prevention or slowing down of aging-related diseases and conditions, and sustainment of function during the aging process.
ANTI-IGF-I RECEPTOR ANTIBODY
The present invention provides an anti-IGF-I receptor antibody that binds specifically to an IGF-I receptor of a vertebrate and has the proliferation-inducing activity of a vertebrate-derived cell, or a fragment thereof, or derivatives of these.
IMMUNOREGULATORY COMPOUNDS
Provided is a compound of Formula 1
##STR00001##
wherein A.sup.1 is selected from CH.sub.2, CHR.sup.4, CR.sup.4R.sup.5, NH, NR.sup.4, O, or S; A.sup.2, A.sup.3, A.sup.4, and A.sup.5 are each independently selected from CH, CR.sup.6, or N; R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.5, R.sup.6, when present, are independently hydrogen, hydroxy, acetyl, halo, carboxyl; a substituted or unsubstituted amino, alkyl, alkoxy, carboxyalkyl, alkylamide, acyl, acylamino aryl, arylalkyl, heteroalkyl, heteroalkoxy, heterocarboxyalkyl, heteroacyl, heteroacylamino, heteroaryl, or heteroarylalkyl; or a substituted or unsubstituted five-membered heterocycle where any member of the given ring may be C, N, O, or S.
Also provided is a method of treating a mammal undergoing an inflammatory disease, the method comprising administering the above compound to the mammal in a manner sufficient to reduce the severity of the inflammatory disease.
Stable, highly pure L-cysteine compositions for injection and methods of use
The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O.sub.2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
COMPOUNDS,COMPOSITIONS, AND METHODS FOR THE TREATMENT OF DISEASE
Disclosed are compounds and compositions for the activation or induction of expression of a pattern recognition receptor (e.g., STING, RIG-I, MDA5), and methods of use thereof.
Composition comprising EPA and DHA ethylester for parenteral administration
Described herein are compositions for parenteral administration that include an aqueous phase and 5 to 30%, by weight, of an oil phase, based on the total weight of the composition. The oil phase comprises the omega-3 fatty acid ethylesters eicosapentaenoic acid ethylester, docosahexaenoic acid ethylester, and mixtures thereof. The composition further comprises at least one anionic surfactant and at least one amphoteric surfactant, and less than 0.05% by weight of oleic acid, based on the total weight of the composition. Also described is a method for preparing such a composition as well as such compositions for use as a medicament, in particular for use in treating stroke, sepsis, Alzheimer's disease or cancer. Also featured are methods of treating these conditions by parenterally administering a composition to a patient in need thereof and methods of providing parenteral nutrition to such patients by administering to them a composition as described herein.
DIETARY EMULSION FORMULATIONS AND METHODS FOR USING THE SAME
Disclosed herein is a formulation that can take the form of an emulsion which contains total enteral or parenteral nutrition for a recipient subject. The formulation includes as the sole fat components: (i) medium chain triglycerides; and (ii) very long chain fatty acids selected from (a) very long chain omega-3 polyunsaturated fatty acids; and (b) docosahexaenoic acid and arachidonic acid in a ratio of about 10:1 (v/v or w/w) to about 2000:1 (v/v or w/w). The sole fat components provide about 10% to about 90% total calories of the formulation, and the medium chain triglycerides provide about 25%-95% total fat calories of the formulation. Methods and kits for utilizing the formulation and for treating various disorders and diseases that involve an inflammatory response are also disclosed.