MODIFIED RELEASE VALPROIC ACID SOFTGEL CAPSULE
Softgel capsules comprise a fill composition and a shell composition, wherein the fill composition includes valproic acid and the shell composition includes gelatin, a plasticizer, and an enteric polymer. The softgel capsules further include from 125 mg to 1000 mg dosing of valproic acid. A method for producing the softgel capsule using a gel mass and rotary die encapsulation is also provided.
1 . A softgel capsule comprising:
(a) a fill material; and
(b) a shell composition,
wherein the fill material comprises valproic acid or a salt thereof, and
wherein the shell composition comprises a gelatin, a plasticizer, and an enteric polymer.
2 . The softgel capsule of claim 1 , wherein the shell composition further comprises dextrose.
3 . The softgel capsule of claim 1 , wherein the enteric polymer is pectin.
4 . The softgel capsule of claim 3 , wherein the pectin is an amidated pectin, a non-amidated pectin or combinations thereof.
5 . The softgel capsule of claim 1 , wherein the shell composition comprises about 25 wt % to about 55 wt % of a gelatin.
6 . The softgel capsule of claim 1 , wherein the shell composition comprises about 3 wt % to about 22 wt % of pectin.
7 . The softgel capsule of claim 1 , wherein the shell composition comprises about 0.01 wt % to about 1.0 wt % of dextrose.
8 .- 10 . (canceled)
11 . The softgel capsule of claim 1 , wherein the plasticizer is glycerin, aqueous sorbitol and sorbitan solution or combinations thereof.
12 . (canceled)
13 . (canceled)
14 . The softgel capsule of claim 1 , wherein the shell composition further comprises a gelling agent.
15 . (canceled)
16 . (canceled)
17 . The softgel capsule of claim 1 , wherein the fill composition further comprises an antioxidant.
18 . The softgel capsule of claim 17 , wherein the antioxidant comprises butylated hydroxytoulene (BHT) or butylated hydroxyanisole (BHA).
19 . (canceled)
20 . The softgel capsule of claim 1 , wherein the fill composition comprises from about 125 mg to about 1000 mg of valproic acid.
21 . (canceled)
22 . (canceled)
23 . The softgel capsule of claim 1 , wherein the softgel capsule has a stability of at least about 90% when tested at 25° C./60% RH at 1 month, 2 months, 3 months, 6 months, 12 months, or 24 months.
24 .- 28 . (canceled)
29 . The softgel capsule of claim 1 , wherein the softgel capsule has a stability of at least about 90% when tested at 30° C./65% RH at 1 month, 2 months, 3 months, 6 months, or 12 months.
30 .- 34 . (canceled)
35 . The softgel capsule of claim 1 , wherein the softgel capsule has a stability of at least about 90% when tested at 40° C./75% RH at 1 month, 2 months, 3 months, or 6 months.
36 - 45 . (canceled)
46 . The softgel capsule of claim 1 , wherein the total impurity does not exceed about 0.5%, about 0.4%, about 0.3%, about 0.2%, about 0.1% or about 0.01%, wherein the total impurity is measured per current USP Monograph test method.
47 . (canceled)
48 . A process for producing the softgel capsule of claim 1 , comprising encapsulating the fill composition in the shell composition to form the softgel capsule and drying the softgel capsule.
49 . The process of claim 48 , wherein prior to encapsulating a gel conversion occurs for the shell composition.
50 . A method of treating seizures comprising administering a softgel capsule of claim 1 .
51 . A method of treating bipolar disorder comprising administering a softgel capsule of claim 1 .
52 . (canceled)