Niclosamide Formulations and Methods of Use
OwnerAkash BAKSHI, Nadja MANNOWETZ +1inventors
InventorsAkash BAKSHI, Nadja MANNOWETZ, Andrew BARTYNSKI
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Abstract
Disclosed are niclosamide formulations for use in the treatment and prevention of viral infection. In some embodiments, the infection is transduced by a coronavirus, including a SARS-Cov-2 virus.
Claims276
A formulation comprising an amount of niclosamide, wherein the niclosamide comprises a dry and solid form, and one or more of a surfactant, a excipient, a pH modulator, a preservative, a binder, a glidant, a dispersant, a disintegrant and a filler.
The formulation of any one of claims 36-31, wherein the food or the beverage comprises alcohol.
A formulation comprising
- (a) niclosamide, comprising about 55% to about 56% weight by weight of the formulation;
- (b) mannitol, comprising about 8% to about 9% weight by weight of the formulation;
- (c) MCC, comprising about 15% to about 16% weight by weight of the formulation;
- (d) SLS, comprising about 5% weight by weight of the formulation;
- (e) Sodium Starch Glycolate, comprising about 8% weight by weight of the formulation;
- (f) Hydroxypropyl cellulose (HPC), comprising about 5% weight by weight of the formulation;
- (g) Colloidal Silicon Dioxide, comprising about 0.5% weight by weight of the formulation;
- and
- (h) Sodium Stearyl Fumarate, comprising about 2% weight by weight of the formulation.
A formulation comprising
- (a) niclosamide, comprising about 55.5% weight by weight of the formulation;
- (b) mannitol, comprising about 8.8% weight by weight of the formulation;
- (c) MCC, comprising about 15.1% weight by weight of the formulation;
- (d) SLS, comprising about 5% weight by weight of the formulation;
- (e) Sodium Starch Glycolate, comprising about 8% weight by weight of the formulation;
- (f) Hydroxypropyl cellulose (HPC), comprising about 5% weight by weight of the formulation;
- (g) Colloidal Silicon Dioxide, comprising about 0.5% weight by weight of the formulation;
- and
- (h) Sodium Stearyl Fumarate, comprising about 2% weight by weight of the formulation.
A formulation comprising
- (a) about 250 mg of niclosamide;
- (b) about 39.6 mg of mannitol,
- (c) about 68.1 mg of MCC;
- (d) about 22.5 mg of SLS;
- (e) about 36 mg of Sodium Starch Glycolate;
- (f) about 22.5 mg of Hydroxypropyl cellulose (HPC);
- (g) about 2.3 mg of Colloidal Silicon Dioxide;
- and
- (h) about 9 mg of Sodium Stearyl Fumarate.
A formulation comprising (i) intra-granular components and (ii) extra-granular components;
- wherein the intra-granular components comprise:
- (a) niclosamide, comprising about 55% to about 56% weight by weight of the formulation;
- (b) mannitol, comprising about 8% to about 9% weight by weight of the formulation;
- (c) MCC, comprising about 15% to about 16% weight by weight of the formulation;
- (d) SLS, comprising about 5% weight by weight of the formulation;
- (e) Sodium Starch Glycolate, comprising about 5% weight by weight of the formulation;
- (f) Hydroxypropyl cellulose (HPC), comprising about 5% weight by weight of the formulation;
- (g) Colloidal Silicon Dioxide, comprising about 0.3% weight by weight of the formulation;
- and
- (h) Sodium Stearyl Fumarate, comprising about 1% weight by weight of the formulation;
- and
- wherein the extra-granular components comprise:
- (i) Sodium Starch Glycolate, comprising about 3% weight by weight of the formulation;
- (j) Colloidal Silicon Dioxide, comprising about 0.2% weight by weight of the formulation;
- and
- (k) Sodium Stearyl Fumarate, comprising about 1% weight by weight of the formulation.
A formulation comprising (i) intra-granular components and (ii) extra-granular components;
- wherein the intra-granular components comprise:
- (a) niclosamide, comprising about 55.6% weight by weight of the formulation;
- (b) mannitol, comprising about 8.8% weight by weight of the formulation;
- (c) MCC, comprising about 15.1% weight by weight of the formulation;
- (d) SLS, comprising about 5% weight by weight of the formulation;
- (e) Sodium Starch Glycolate, comprising about 5% weight by weight of the formulation;
- (f) Hydroxypropyl cellulose (HPC), comprising about 5% weight by weight of the formulation;
- (g) Colloidal Silicon Dioxide, comprising about 0.3% weight by weight of the formulation;
- and
- (h) Sodium Stearyl Fumarate, comprising about 1% weight by weight of the formulation;
- and
- wherein the extra-granular components comprise:
- (i) Sodium Starch Glycolate, comprising about 3% weight by weight of the formulation;
- (j) Colloidal Silicon Dioxide, comprising about 0.2% weight by weight of the formulation;
- and
- (k) Sodium Stearyl Fumarate, comprising about 1% weight by weight of the formulation.
A formulation comprising (i) intra-granular components and (ii) extra-granular components;
- wherein the intra-granular components comprise:
- (a) about 250 mg of niclosamide;
- (b) about 39.6 mg of mannitol;
- (c) about 68.1 mg of MCC;
- (d) about 22.5 mg of SLS;
- (e) about 22.5 mg of Sodium Starch Glycolate;
- (f) about 22.5 mg of Hydroxypropyl cellulose (HPC);
- (g) about 1.4 mg of Colloidal Silicon Dioxide;
- and
- (h) about 4.5 mg of Sodium Stearyl Fumarate;
- and
- wherein the extra-granular components comprise:
- (i) about 13.5 mg of Sodium Starch Glycolate;
- (j) about 0.9 mg of Colloidal Silicon Dioxide;
- and
- (k) about 4.5. mg of Sodium Stearyl Fumarate.
A method of increasing systemic bioavailability of niclosamide comprising mixing niclosamide with an amount of SLS that is at least about 3.0%, at least about 3.5%, at least about 4.0%, at least about 4.5%, at least about 5.0%, at least about 5.5%, at least about 6.0%, or at least about 6.5% weight by weight.
Dependencies are inferred from the claim text.