Pharmaceutical compositions for treating acne
AssigneeDr. Reddy's Laboratories, Inc.
InventorsYogesh Bapurao Pawar, Kailas Khomane, Saurabh Srivastava, Bijay Kumar Padhi, Rajeev Singh Raghuvanshi
Life of this patent
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Abstract
The present application relates to pharmaceutical compositions comprising retinoic acid or its derivatives such as isotretinoin and processes for preparing thereof. It also provides methods for treating acne by administering such pharmaceutical composition to a patient in need thereof.
Claims31
A once daily solid oral pharmaceutical composition of isotretinoin comprising:
- (a) an extended release (ER) portion comprising
- (i) isotretinoin or a pharmaceutically acceptable salt thereof;
- (ii) a solubility improving polymer comprising from about 10% w/w to about 40% w/w of the composition;
- and
- (iii) a rate controlling agent comprising from about 5% w/w to about 20% w/w of the composition;
- and
- (b) an immediate release portion comprising
- (i) isotretinoin or a pharmaceutically acceptable salt thereof;
- (ii) a solubility improving polymer comprising from about 10% w/w to about 40% w/w of the composition;
- wherein said solubility improving polymer and isotretinoin are present in a weight ratio at least about 2.0:1.0;
- wherein said isotretinoin is in an amorphous form and substantially free of crystalline particles;
- and
- wherein said composition comprises (i) about 60 to about 80 percent of isotretinoin in an extended release (ER) portion, (ii) about 40 to about 20 percent of isotretinoin in an immediate release (IR) portion;
- and (iii) one or more pharmaceutically acceptable excipients.
A method of treating acne in a patient in need thereof comprising orally administering to the patient a once daily solid oral pharmaceutical composition of isotretinoin comprising:
- (a) an extended release (ER) portion comprising
- (i) isotretinoin or a pharmaceutically acceptable salt thereof;
- (ii) a solubility improving polymer comprising from about 10% w/w to about 40% w/w of the composition;
- and
- (iii) a rate controlling agent comprising from about 5% w/w to about 20% w/w of the composition;
- and
- (b) an immediate release portion comprising
- (i) isotretinoin or a pharmaceutically acceptable salt thereof;
- (ii) a solubility improving polymer comprising from about 10% w/w to about 40% w/w of the composition;
- wherein said solubility improving polymer and isotretinoin are present in a weight ratio at least about 2.0:1.0;
- wherein said isotretinoin is in an amorphous form and substantially free of crystalline particles;
- and
- wherein said composition comprises (i) about 60 to about 80 percent of isotretinoin in an extended release (ER) portion, (ii) about 40 to about 20 percent of isotretinoin in a delayed release (DR) portion;
- and (iii) one or more pharmaceutically acceptable excipients.
A once daily solid oral pharmaceutical composition of isotretinoin comprising:
- (a) an extended release (ER) portion and (b) a delayed release (DR) portion, wherein said release portions comprises,
- (i) isotretinoin or a pharmaceutically acceptable salt thereof;
- (ii) a solubility improving polymer comprising from about 10% w/w to about 40% w/w of the composition;
- and
- (iii) a rate controlling agent comprising from about 5% w/w to about 20% w/w of the composition;
- wherein said solubility improving polymer and isotretinoin are present in a weight ratio at least about 2.0:1.0;
- wherein said isotretinoin is in an amorphous form and substantially free of crystalline particles;
- and
- wherein said composition comprises (i) about 60 to about 80 percent of isotretinoin in an extended release (ER) portion, (ii) about 40 to about 20 percent of isotretinoin in a delayed release (DR) portion;
- and (iii) one or more pharmaceutically acceptable excipients.
A method of treating acne in a patient in need thereof comprising orally administering to the patient a once daily solid oral pharmaceutical composition of isotretinoin comprising:
- (i) an extended release (ER) portion and (ii) a delayed release (DR) portion, wherein said release portions comprises,
- (i) isotretinoin or a pharmaceutically acceptable salt thereof;
- (ii) a solubility improving polymer comprising from about 10% w/w to about 40% w/w of the composition;
- and
- (iii) a rate controlling agent comprising from about 5% w/w to about 20% w/w of the composition;
- wherein said solubility improving polymer and isotretinoin are present in a weight ratio at least about 2.0:1.0;
- wherein said isotretinoin is in an amorphous form and substantially free of crystalline particles;
- and
- wherein said composition comprises (i) about 60 to about 80 percent of isotretinoin in an extended release (ER) portion, (ii) about 40 to about 20 percent of isotretinoin in a delayed release (DR) portion;
- and (iii) one or more pharmaceutically acceptable excipients.
Dependencies are inferred from the claim text.