# US 2014/0193491 A1 · Pharmaceutical antiretroviral composition > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0193491 A1 - Document ID: US20140193491A1 - Status: Published application - Kind: A1 - Application number: 14/119,144 - Filed: 2012-05-30 - Published: 2014-07-10 - Earliest claimed: 2011-05-30 - Assignees: Cipla Limited - Inventors: Geena Malhotra; Shrinivas Madhukar Purandare - Web page: https://patentgrep.com/patent/US20140193491A1 ## CPC - A61K 9/2086: {Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat (active cores with a complete drug-free outer coat A61K9/28)} - A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer} - A61K 9/2095: {Tabletting processes} - A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine - A61K 31/551: having two nitrogen atoms, e.g. dilazep - A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate - A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 31/18: for HIV - A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates to a pharmaceutical antiretroviral composition comprising (i) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine, (ii) extended release nevirapine, and (iii) tenofovir; a process for preparing such composition and the use of such composition in medicine, particularly for the prophylaxis and/or treatment of diseases caused by retroviruses. ## Claims ### Claim 1 A pharmaceutical antiretroviral composition comprising (i) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine, (ii) extended release nevirapine, and (iii) tenofovir or its pharmaceutically acceptable salts, solvates, esters, hydrates, enantiomers, derivatives, polymorphs, prodrugs, complexes. ### Claim 2 (depends on 1) The pharmaceutical composition according to claim 1, wherein the nucleoside reverse-transcriptase inhibitor is lamivudine or its pharmaceutically acceptable salts, solvates, esters, hydrates, enantiomers, derivatives, polymorphs, prodrugs, complexes. ### Claim 3 (depends on 1) The pharmaceutical composition according to claim 1, wherein the nucleoside reverse-transcriptase inhibitor is emtricitabine or its pharmaceutically acceptable salts, solvates, esters, hydrates, enantiomers, derivatives, polymorphs, prodrugs, complexes. ### Claim 4 (depends on 1) The pharmaceutical composition according to claim 1 adapted for once or twice a day administration. ### Claim 5 (depends on 1) The pharmaceutical composition according to claim 1 in single complete package. ### Claim 6 (depends on 5) The pharmaceutical composition according to claim 5 in the form a single layer, or a bilayer or trilayer or multilayer tablet. ### Claim 7 (depends on 1) The pharmaceutical composition according to claim 1, wherein nevirapine is co-formulated with at least one hydrophilic and/or hydrophobic and/or water-swellable polymer. ### Claim 8 (depends on 7) The pharmaceutical composition according to claim 7, wherein nevirapine is coated or blended or complexed with one or more hydrophilic and/or hydrophobic and/or water-swellable polymers. ### Claim 9 (depends on 1) The pharmaceutical antiretroviral composition according to claim 1, comprising: (i) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine; tenofovir, and one or more pharmaceutically acceptable excipients to form a first admixture; and (ii) nevirapine in an extended release system with one or more pharmaceutically acceptable excipients to form a second admixture, which first and second admixtures are blended and compressed in a single layer to provide a single unit dosage form. ### Claim 10 (depends on 1) The pharmaceutical antiretroviral composition according to claim 1, comprising: (i) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine; tenofovir and one or more pharmaceutically acceptable excipients to form a first admixture; and (ii) nevirapine in an extended release system with one or more pharmaceutically acceptable excipients to form a second admixture; which first and second admixtures are blended and compressed to provide a bilayer unit dosage form. ### Claim 11 (depends on 1) The pharmaceutical antiretroviral composition according to claim 1, comprising: (i) tenofovir and one or more pharmaceutically acceptable excipients to form a first admixture; and (ii) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine; nevirapine in an extended release system, and one or more pharmaceutically acceptable excipients to form a second admixture; which first and second admixtures are blended and compressed to provide a bilayer unit dosage form. ### Claim 12 (depends on 1) The pharmaceutical antiretroviral composition according to claim 1, comprising: (i) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine with one or more pharmaceutically acceptable excipients to form a first admixture; and (ii) tenofovir, nevirapine in an extended release system with one or more pharmaceutically acceptable excipients to form a second admixture; which first and second admixtures are blended and compressed to provide a bilayer unit dosage form. ### Claim 13 (depends on 1) The pharmaceutical antiretroviral composition according to claim 1, comprising: (i) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine, with one or more pharmaceutically acceptable excipients to form a first admixture; and (ii) tenofovir along with one or more pharmaceutically acceptable excipients to form a second admixture; and (iii) nevirapine in an extended release system with one or more pharmaceutically acceptable excipients to form a third admixture; which first, second and third admixtures are blended and compressed to provide a trilayer unit dosage form. ### Claim 14 (depends on 1) The pharmaceutical composition according to claim 1 as a combined preparation for simultaneous or separate use in the treatment of an HIV infection. ### Claim 15 (depends on 1) A process for preparing a pharmaceutical composition according to claim 1, which process comprises admixing (i) a nucleoside reverse-transcriptase inhibitor selected from lamivudine and emtricitabine, (ii) extended release nevirapine, and (iii) tenofovir with one or more pharmaceutically acceptable excipients. ### Claim 16 (depends on 1) A method of preventing, treating or prophylaxis of diseases caused by retroviruses, especially acquired immune deficiency syndrome or an HIV infection, which method comprises administering a pharmaceutical antiretroviral composition according to claim 1 to a patient in need thereof. ### Claim 17 (canceled)