This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) and pharmaceutical compositions thereof. Also disclosed herein are methods of making the pharmaceutical compositions of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.

The present invention relates to a pharmaceutical composition for oral administration, particularly in the form of a tablet, comprising darolutamide or a pharmaceutically acceptable salt thereof as an active ingredient. Darolutamide is a potent androgen receptor (AR) modulator useful in the treatment of cancer, particularly AR dependent cancer such as prostate cancer, and other diseases where AR antagonism is desired.

The invention relates to stable pharmaceutical formulation useful for the oral administration comprising a peptide or protein drug and a permeation enhancer. In particular, the invention relates to stabilized pharmaceutical formulations comprising GLP-1 receptor agonist such as Semaglutide and a permeation enhancer and its process for preparation.

Pharmaceutical compositions are provided, which comprise cabozantinib or pharmaceutically acceptable salts thereof, and at least one pharmaceutically acceptable excipient, wherein the inventive compositions exhibit enhanced bioavailability compared to the currently marketed or commercially available formulations. The present invention also provides manufacturing processes thereof and use of the said inventive compositions for the prevention, treatment or prophylaxis of disorders in human patients in need thereof. The present invention relates to oral pharmaceutical compositions of cabozantinib, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cabozantinib.

The present invention provides a method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject a therapeutically effective amount of a Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, or a therapeutically effective amount of intravenous immunoglobulin, or a therapeutically effective amount of a therapeutic agent that destroys B lymphocytes, or a combination thereof. The present invention also provides kits containing the same.

A bilayer composition for amelioriation of, or prophylaxis against, SARS-CoV-2 infection comprising a: (i) a first layer consisting of 250 mg to 1600 mg of 5-aminolevulinic acid (ALA), or salt thereof, and pharmaceutically acceptable excipients that allow for immediate release of the 5-aminolevulinic acid; (ii) a second layer consisting of hydroxychloroquine (HCQ), and/or a salt thereof, in a dose of 100 mg-1500 mg, or salt thereof, and at least one pharmaceutically acceptable excipient comprising a release modifier for sustained release of the hydroxychloroquine or chloroquine.

The invention discloses polymorphic forms of a compound of formula I, pharmaceutical compositions containing same, preparation method therefor and use thereof. The compound of formula I of the present invention is as shown in formula I, of which the crystalline form can be crystalline form 1, crystalline form 2, crystalline form 3, crystalline form 5, crystalline form 6 or crystalline form 7. All the crystalline forms of the compound of formula I in the present invention have good crystalline stability and chemical stability and a decrease in purity of their main ingredient less than 2%. The preparation method of the present invention may be used to produce the various crystalline forms of the compound of formula I with high purity, and suitable for large scale production.

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The invention provides gastric residence systems for administration of adamantane-class drugs or pharmaceutically acceptable salts thereof, such as memantine or pharmaceutically acceptable salts thereof, and methods for making and using such systems. The systems provide extended release of drug, reducing the frequency with which the drug must be administered to the patient. The gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, can have release rate-modulating films, which provide good control over release of adamantane-class drugs or pharmaceutically acceptable salts thereof present in the gastric residence system. Some embodiments of the films can provide resistance against burst release of adamantane-class drugs or pharmaceutically acceptable salts thereof upon exposure to alcohol.

An oseltamivir formulation and a preparation method of the formulation, the method being simple to operate, having good reproducibility, and being suitable for manufacture. The oseltamivir formulation includes oseltamivir or a salt thereof and a sustained-release material. The formulation may be a single-phase release formulation, a dual-phase release formulation, a three-phase release formulation, or a multi-phase release formulation having more than three phases. The formulation is administered once-daily and can achieve sustained release of at least 24 hours or longer, which can reduce the times of administration and avoid peak-to-valley fluctuations, thereby improving the compliance and safety of patients.

Described herein, in part, are tablets, such as immediate release multi-layer or bilayer tablets for orally delivering olanzapine and samidorphan, methods of using said tablets in the treatment of disorders described herein, and kits comprising said tablets.