Back to results
US 2026/0248729 A1Published application
Novel oral dosage form
AssigneeNeon Healthcare Ltd
InventorsStephen Knightley, Dharmik Patel, Bikrum Prem
Life of this patent
Estimating the term…
Abstract
The invention relates to an oral dosage form comprising phenelzine and a film coating, characterised in that said film coating is an aqueous based film coating. The invention also relates to said oral dosage form for use in the treatment of depression (such as major depressive disorder (MDD)), anxiety, or a disorder related to depression or anxiety.
Claims27
An oral dosage form comprising:
- (a) a pharmaceutical composition comprising phenelzine or a pharmaceutically acceptable salt thereof, in combination with one or more pharmaceutically acceptable excipients;
- and
- (b) a film coating surrounding said pharmaceutical composition;
- said wherein the film coating is an aqueous based film coating.
1 more element
2-26. (canceled)
The oral dosage form as described in Tables 1 and 2:
- TABLE 1
- Composition of Drug Product
- Quantity
- Reference
- Ingredient
- (mg/tab)
- Function
- Standard
- Active Substance
- Phenelzine Sulfate
- 25.83
- Active
- BP
- (Equivalent to
- Phenelzine base 15 mg)
- Excipients
- Mannitol
- 185.96
- Diluent
- Ph. Eur.
- Povidone
- 6.83
- Disintegrant
- Ph. Eur.
- Magnesium Stearate
- 6.81
- Lubricant
- Ph. Eur.
- Maize Starch
- 4.57
- Binder
- Ph. Eur.
- Isopropyl alcohol
- ND
- Solvent
- Ph. Eur.
- Film Coating
- Opadry AMB II Orange
- 13.80
- Coating
- See Table 2
- Water Purified
- ND
- Solvent
- Ph. Eur.
- TABLE 2
- Composition of Opadry AMB II Orange
- Quantity
- %
- Ingredient
- (mg/tab)
- w/w
- Function
- Reference Standard
- Polyvinyl
- 5.45
- 39.5
- Coating
- USP, FCC, Ph. Eur,
- Alcohol
- JPE, ChP, GB
- Talc
- 5.24
- 38.0
- Coating
- USP, FCC, Ph. Eur,
- JP, JECFA
- Sunset Yellow
- 1.52
- 11.0
- Coating
- JECFA, JSFA, JP
- FCF
- Aluminum Lake
- MO, GB
- Glyceryl
- 0.62
- 4.5
- Coating
- NF, Glycerol of FA
- Dicaprylocaprate
- JSFA
- Glyceryl Mono-
- Type 1 Ph. Eur,
- caprylocaprate
- Glycerol of FA
- JSFA
- Sodium Lauryl
- 0.41
- 3.0
- Coating
- NF, Ph. Eur, JP,
- Sulfate
- ChP 2015
- Titanium
- 0.41
- 3.0
- Coating
- USP, FCC, Ph. Eur,
- Dioxide
- JP, JSFA, ChP, GB
- Carmine
- 0.14
- 1.0
- Coating
- FCC, JPE, JECFA
103 more elements
Dependencies are inferred from the claim text.