Claims for Patent: 10,363,324

Summary for Patent: 10,363,324

Title:	Pharmaceutical composition
Abstract:	This invention relates to a pharmaceutical composition for parenteral or oral administration containing a radioactive compound which can be used diagnostically or therapeutically. The composition comprises a micro-emulsion constituted by a dispersion of vesicles or microsponges of a fatty acid based component in an aqueous or other pharmacologically acceptable carrier in which nitrous oxide is dissolved, the fatty acid based component comprising at least one long chain fatty acid based substance selected from the group consisting of free fatty acids and derivatives of free fatty acids, and the radioactive compound.
Inventor(s):	Grobler; Anne Frederica (North West Province, ZA), Zeevaart; Jan Rijn (Pelindaba, ZA)
Assignee:	The South African Nuclear Energy Corporation Limited (Brits Magisterial District, ZA) North-West University (Potchefstroom, ZA)
Application Number:	15/034,281
Patent Claims:	1. A method of administering a radiolabelled pharmaceutical compound to a subject in need thereof, the method including the steps of: providing a micro-emulsion constituted by a dispersion of vesicles or microsponges of a fatty acid based component in an aqueous or other pharmacologically acceptable carrier in which nitrous oxide is dissolved, the fatty acid based component comprising at least one long chain fatty acid based substance selected from the group consisting of oleic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, ricinoleic acid, eicosapentaenoic acid [C20 5.omega.3], and decosahexaenoic acid [C22 6.omega.3] and derivatives thereof selected from the group consisting of the C1 to C6 alkyl esters thereof, the glycerol-polyethylene glycol esters thereof, and a reaction product of hydrogenated and unhydrogenated natural oils comprising ricinoleic acid based oils with ethylene oxide, mixed with a composition containing a radiolabelled pharmaceutical compound comprising a radioactive compound labelled to a pharmaceutical compound wherein the radioactive compound is selected from .sup.99mTc, .sup.188Re, .sup.186Re, .sup.153Sm, .sup.166Ho, .sup.90Sr, .sup.89Sr, .sup.67Ga, .sup.68Ga, .sup.111In, .sup.183Gd, .sup.59Fe, .sup.225Ac, .sup.212Bi, .sup.211At, .sup.211At, .sup.45Ti, .sup.60Cu, .sup.61Cu, .sup.67Cu, .sup.64Cu, .sup.62Cu, .sup.195mPt, .sup.191mPt, .sup.193mPt, .sup.117mSn, .sup.103Pd, .sup.103mRh, .sup.89Zr, .sup.177Lu, .sup.223Ra, .sup.224Ra, .sup.32P and .sup.33P, and administering the mixture to the subject orally in a diagnostic or therapeutic method of treatment, wherein the radiolabelled pharmaceutical compound is absorbed through an intestinal tract of the subject and is transported to a required location in the body after administration where the radiolabelled pharmaceutical compound has a diagnostic or therapeutic effect. 2. The method of claim 1, wherein the mixture is left to stand for 45 minutes to 1 hour, prior to administration of the composition to the subject. 3. The method of claim 1, wherein the radiolabelled pharmaceutical compound is a compound selected from: In-111 Oxyquinoline, Tc-99m Disofenin, Tc-99m Lidofenin, Tc-99m Mebrofenin, Tc-99m Disida, Iofetamine I-123, Tc-99m Pyrophosphate, Tc-99m (Pyro- and trimeta-) Phosphates, Tc-99m Albumin Colloid, Tc-99m Sulfur Colloid, Fluodeoxyglucose F-18, In-111 Pentetreotide, Tc-99m Exametazime, Tc-99m Gluceptate, Tc-99m Arcitumomab, Tc-99m Nofetumomab Merpentan, Ferrous Citrate Fe-59, Tc-99m Teboroxime, Tc-99m Tetrofosmin, Thallous Chloride Tl-201, Iodohippurate Sodium I-123, Iodohippurate Sodium I-131, Iothalamate Sodium I-125, Tc-99m Succimer, Cyanocobalamin Co-57, Iobenguane, Sodium I-123, Iobenguane, Sodium I-131, F-18 florbetapir, F-18 florbetaben, F-18 NAV4694, F-18 Flutemetamol, I-123 Ioflupane, I-131 tositumomab, Sm-153 EDTMP, Ho-166 DOTMP, Re-186-HEDP, Sr-89 chloride Y-90 chloride, Y-90 ibritumomab tiuxetan, Re-188-HEDP, Tc-99m-HEDP, Zr-89 DFO-J549, Cu-64 ATSM, P-32 sodium phosphate, Ga-68 DOTATATE, Ga-68 RGD, Ga-68 UBI, Ga-68 citrate, Lu-177 DOTATATE, Lu-177 ibritumomab tiuxetan, Lu-177-EDTMP, F-18 maltose, F-18-maltohexaose, F-18-2-fluorodeoxy sorbitol, Pt-195m cisplatinum, Pt-195m carboplatinum, Pt-195m satraplatin, Pt-195m eloxatin, I-123 Deoxyuridine, I-125 Deoxyuridine, Technescan.TM. HDP (Tc-99m oxidronate), CARDIOLITE.RTM. (Tc-99m sestamibi), AN-DTPA.RTM. (Tc-99m Pentetate), Technescan.TM. MAG3 (Tc-99m mertiatide), Gluscan.RTM. (F-18 FDG), Xofigo.RTM. (Ra-223 Chloride), or Gallium Citrate Ga-67 Injection. 4. The method of claim 1, wherein the radioactive compound is .sup.99mTc. 5. The method of claim 4, wherein the radioactive compound is labelled to a pharmaceutical compound selected from .sup.99mTc (medronic acid) MDP or .sup.99mTc-sestaMIBI (MIBI). 6. The method of claim 1, wherein the mixture administered to the subject orally comprises: 1 .mu.l to 88 ml by volume water; 100 .mu.l to 1300 .mu.l by volume fatty acid, and 370 kBq to 37 GBq radioactivity.

Details for Patent 10,363,324

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Boehringer Ingelheim Pharmaceuticals, Inc.	VERLUMA	nofetumomab	Injection	103769	10/13/1998		2033-11-04
Acrotech Biopharma Llc	ZEVALIN	ibritumomab tiuxetan	Injection	125019	02/19/2002		2033-11-04