.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 8,952,064

« Back to Dashboard

Claims for Patent: 8,952,064

Title:Pharmaceutical semi-solid composition of isotretinoin
Abstract: An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle
Inventor(s): Vanderbist; Francis (Beersel, BE), Servais; Cecile (Malonne, BE), Baudier; Philippe (Uccle, BE)
Assignee: Galephar Pharmaceutical Research, Inc. (Humacao, PR)
Application Number:13/525,857
Patent Claims: 1. An oral pharmaceutical composition in the form of a capsule, wherein the capsule is filled with a composition consisting essentially of a semisolid paste of isotretinoin in a mixture of oil and a glycerol macrogolglyceride of HLB of at least 10, said composition exhibiting a dissolution of at least 40% within 4 hours as measured using USP paddle apparatus at 150 rpm in an aqueous dissolution medium constituted by buffer of pH 7.5, sodium lauryl sulfate 2.5% and pancreatin 1 g/L at 37.degree. C.

2. The oral pharmaceutical composition of claim 1, wherein the composition exhibits an isotretinoin release rate of at least 60% within 4 hours.

3. The oral pharmaceutical composition of claim 1, wherein isotretinoin comprises between 1% to 25% w/w of the composition, the oil comprises between 20% to 80% w/w of the composition and the macrogolglyceride comprises between 5% to 70% w/w of the composition.

4. The oral pharmaceutical composition of claim 1, wherein the oil excipient is selected from the group consisting of vegetable oils, medium chain triglycerides, fatty acid esters, glycerol oleate and mixtures thereof.

5. The oral pharmaceutical composition of claim 1, wherein the glycerol macrogolglyceride excipient has a HLB value of at least 12.

6. The oral pharmaceutical composition of claim 1, wherein the glycerol macrogolglyceride excipient has a HLB value of at least 13.

7. The oral pharmaceutical composition of claim 1, wherein the composition is as semi-solid suspension.

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

9. The oral pharmaceutical composition of claim 8, wherein the surfactant is selected from the group consisting of sorbitan fatty acid esters, polysorbate compounds, polyoxyethylene sorbitan fatty acids esters, sodium lauryl sulphate compounds of lecithin, propylene glycol esters, fatty acid esters of propylene glycol, fatty acid esters of glycerol, and mixtures thereof.

10. The oral pharmaceutical composition of claim 8, wherein the surfactant comprises between 1% to 10% w/w of the composition.

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

12. The oral pharmaceutical composition of claim 11, wherein the disintegrant is selected from the group consisting of crospovidone, sodium croscarmellose, and mixtures thereof.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc