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Claims for Patent: 9,078,925

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Claims for Patent: 9,078,925

Title:Pharmaceutical semi-solid composition of isotretinoin
Abstract: The invention relates to an oral pharmaceutical composition of isotretinoin at least two excipients, one of the excipients being a hydrophilic excipient having an HLB value greater than or equal to 10 and the other excipient being an oily vehicle. The oral pharmaceutical composition is substantially devoid of food effect as characterized by a dissolution profile wherein at least 70% of the oral pharmaceutical composition is dissolved after about four hours in a USP2 dissolution apparatus at a paddle speed of 100 rpm, and a dissolution media composed of 900 mL of pH 7.5 buffer containing 0.11% pancreatin, 4.7% cholic acid, 0.14% sodium dihydroxide phosphate and 0.5% sodium hydroxide at 37.degree. C.
Inventor(s): DeBoeck; Arthur M. (Gurabo, PR), Vanderbist; Francis (Brussels, BE), Servais; Cecile (Mehaigne, BE), Baudier; Philippe (Brussels, BE)
Assignee: GALEPHAR PHARMACEUTICAL RESEARCH, INC. (Humacao, PR)
Application Number:14/133,073
Patent Claims: 1. An oral pharmaceutical composition, comprising isotretinoin, and at least an oil and a glycerol macrogolglyceride of HLB of at least 10, wherein said oral pharmaceutical composition is substantially devoid of food effect when the amount of isotretinoin dissolved attains at least 70% of the oral pharmaceutical composition after about four hours of dissolution in a USP dissolution apparatus number 2 at a paddle speed of 100 rpm, and a dissolution media composed of 900 ml of pH 7.5 buffer containing 0.11% pancreatin, 4.7% cholic acid, 0.14% sodium dihydrogen phosphate and 0.5% sodium hydroxide at 37.degree. C.

2. The oral pharmaceutical composition of claim 1, wherein the glycerol macrogolglyceride comprises from about 20% to about 80% by weight of the pharmaceutical composition.

3. The oral pharmaceutical composition of claim 1, wherein the oil comprises one or more of vegetable oils, medium chain triglycerides, fatty acid esters, amphiphilic oil, glycerol oleate compound, and/or mixtures thereof.

4. The oral pharmaceutical composition of claim 3, wherein the oil comprises from about 5% to about 70% by weight of the pharmaceutical composition.

5. The oral pharmaceutical composition of claim 1, wherein the glycerol macrogolglyceride has an HLB value of greater than 12.

6. The oral pharmaceutical composition of claim 1, which further comprises at least one surfactant.

7. The oral pharmaceutical composition of claim 1, which further comprises at least one disintegrant.

8. The oral pharmaceutical composition of claim 1, wherein 6 capsules containing said composition are 92% dissolved in view of the parameters set forth in Table XIII of the present specification.

9. The oral pharmaceutical composition of claim 1, which is in semi-solid form and is contained in a capsule.

10. The oral pharmaceutical composition of claim 9, wherein said capsule comprises a hard gelatin capsule, soft gelatin capsule, hypromellose capsule or starch capsule.

11. The oral pharmaceutical composition of claim 1, wherein the glycerol macrogolglyceride comprises lauroyl Macrogol-32 glycerides or stearoyl Macrogol-32 glycerides.

12. The oral pharmaceutical composition of claim 1, wherein the oily vehicle comprises soybean oil.

13. The oral pharmaceutical composition of claim 1, which comprises isotretinoin, stearyl Macrogol glycerides, soybean oil, sorbitan monooleate and propyl gallate.

14. The oral pharmaceutical composition of claim 1, wherein said substantially devoid of food effect is no significant food effect.
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