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(19) United States (12) Patent Application Publication (10) Pub US 20100015184Al (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0015184 A1 Tue] (43) Pub. Date: Jan. 21, 2010 (54) METHODS OF MAKING PHARMACEUTICAL Publication Classi?cation COMPONENTS FOR CUSTOMIZED DRUG PRODUCTS (51) Int. Cl. A61K 9/00 (2006.01) (76) Inventor: Stephen M_ Tue], Columbia, SC (52) US. Cl. ...................................................... .. 424/400 (Us) (57) ABSTRACT Correspondence Address: Methods and systems for developing and manufacturing STIPKALA LLC componentized drug product precursor modules that can be 5401 NETHERBY LANE, SUITE 102-A simply assembled to create customized drug products are NORTH CHARLESTON, SC 29420 (US) disclosed. Each module contains components of a ?nal drug product (e.g., active pharmaceutical ingredients, nutritional (21) App1_ NO_; 12/518,311 ingredients, and/or excipients) in a ?xed mixture selected to maximize desired pharmaceutical characteristics (e.g., stabil (22) PCT Filed: Dec_ 13, 2007 ity, manufacturing ef?ciency) and minimize cost. The mod ules can be extensively tested for quality and assembled (86) PCT NO _ PCT M52007 I025 43 0 immediately, or at a later time, in multiple combinations to " customize the ?nal drug product characteristics (e.g., mul § 371 (6X1), tiple active ingredients, doses, ?avor, viscosity, etc.) to meet (2)’ (4) Date: Jun 9, 2009 individual patient/consumer needs and/or preferences While assuring high quality. Permitted combinations may be main . tained in a database to enable networked dru roduct selec Related U's'Apphcatlon Data tion, prescribing, and ordering. Each resulgnrg customized (60) Provisional application No, 60/874,554, ?led on Dec, drug product dose can be labeled to facilitate compliance and 13, 2006. reduce the number of drug products administered per day. Patent Application Publication Jan. 21, 2010 Sheet 1 0f 7 US 2010/0015184 A1 Figure 1 API module dose selection Search public clinical, medical, and health literature, especially pediatric, geriatric, and metabolic disease areas De?ned minimum and maximum License or create additional doses, minimum escalation proprietary dose knowledge interval dose Convert, as necessary, relative doses to absolute doses Minimum dose is N0 Analysis of clinical use, market ultiple of escalation interv demand, and total dosing range or viceversa V Select greatest common factor or smaller of minimum dose and escalation interval Minimum dose No is greater than escalation interval Select minimum dose Yes as API module close Select escalation interval as API module close I Broad total dosing range Develop one API module dose Market and manufacturing analysis » Develop two API module doses Patent Application Publication Jan. 21, 2010 Sheet 2 0f 7 US 2010/0015184 A1 Figure 2 API module excipient selection N Liquid formulation 0 Available public Available public or proprietary data on API or proprietary data on granul solubility formulation License/create additional formulation knowledge Add solubilizers, Develop simplified antioxidants, pH modi?ers coated granules; only if absolutely necessary 1 binder i i sustained release characteristics Avoid flavors, sweeteners, colors, or viscosity agents ‘ i Minimize granule size Use aseptic process to avoid antiseptics/preservatives l Minimize liquid volume L i, Goal is minimum number of excipients Patent Application Publication Jan. 21, 2010 Sheet 3 0f 7 US 2010/0015184 A1 Figure 3 Excipient module component selection Liquid formulation N Yes N ‘ Taste-masking module 0 Compare volumes of solid dose API Yes module portfolio with Select portfolio of sweet and non- total vom‘mes °f_?na| — sweet ?avors; add sweeteners, other formulat'on opt'ons taste-masking agents as needed ‘ Select limited No number of target Colorant module volumes for ‘filler’ Yes modules _ Develop limited number of color com- ' ‘ ponents with maximum compatibility se|ect physica| components of modules Viscosity module No Yes Develop limited number of viscosity agents with maximum compatibility Develop limited number of preservative modules with maximum compatibility l Goal is minimum number of excipient modules with maximum flexibility of combinations Patent Application Publication Jan. 21, 2010 Sheet 4 0f 7 US 2010/0015184 A1 Figure 4 Module portfolio management Potential new API module No Dose/concentration inside range of existing Yes modules Select dose sqect ——> (see Fig 1) —> exclpients Assess analytical, (see F'Q- 2) formulation, and manufacturing issues Need for No new excipient module(s Potential new excipient module components alters need for __| 1 Select excipient > module components (see Fig. 3) No Additional opportunities to use module Change in Y components creates new Reassess market, opportunities business factors l GolNoGo decision Patent Application Publication Jan. 21, 2010 Sheet 5 0f 7 US 2010/0015184 A1 Figure 5 Module selection for final assembly Select ?rst API module type i Select number of API modules Select next API to provide a'dose based on module type ‘ users physical and clinical measures, age, species/breed, A or other characteristics Additional API Liquid N0 needed formulation Yes _ Select compatible Select ?nal Compatible taste-masking product form and AP' module module(s) size, e.g., capsule available + Select compatible V colorant, viscosity, Select number and/or preservative of excipient modules as needed (filler) modules All needed , modules available Fon/vard need for additional modules to R&D Assemble into ?nal product or package for later assembly Patent Application Publication Jan. 21, 2010 Sheet 6 of7 US 2010/0015184 A1 Figure 6 Final assembly options API Excipient module module portfolio portfolio Packaged modules Modules for ?nal product Delayed Consumer assembly assembly lm mediate assembly Yes Manual or Manual or automated process automated process l Patent Application Publication Jan. 21, 2010 Sheet 7 of7 US 2010/0015184 A1 Figure 7 Quality control and ordering processes Public chemical, pharma ceutical, medical, and veterinary information Module design and development Batch manufacturing : ’¥ *b License/create of modules proprietary information Quality and stability testing l Module assembly ‘ Permitted combinations database/ordering application V t Packaging/shipping 4 Internet A A '’ \ . Physician, veterinarian, or other health professional US 2010/0015184 A1 Jan. 21,2010 METHODS OF MAKING PHARMACEUTICAL [0007] In some embodiments, the present invention COMPONENTS FOR CUSTOMIZED DRUG includes a method and system for developing and manufac PRODUCTS turing componentiZed drug product precursor modules that can be simply assembled to create customiZed drug products. CROSS REFERENCE TO RELATED Some precursor modules of the present system contain tWo or APPLICATIONS more components of a ?nal drug product in a ?xed mixture selected to maximiZe desired pharmaceutical characteristics [0001] This application claims bene?t of priority under and minimize cost. The modules are divided into tWo classes: PCT Chapter I, Article 8, and 35 U.S.C. § 119(e) of US. 1) modules containing an active pharmaceutical ingredient or Provisional Application No. 60/874,554, entitled “Method of speci?c nutritional ingredient (hereafter called API), and 2) Making Pharmaceutical Components for Assembly of Cus modules containing only excipients. tomiZed Drug Products,” ?led on Dec. 13, 2006, Which is incorporated herein by reference. [0008] The modules can be extensively tested for quality and assembled in multiple predetermined combinations, cus tomiZing the ?nal drug product characteristics to meet TECHNICAL FIELD patient/consumer needs and/or preferences While assuring [0002] This invention relates to methods and systems for high quality. Permitted combinations can be maintained in an developing and manufacturing componentiZed drug product Internet-linkable computer database to enable netWorked precursor modules that can be assembled to create custom drug product selection, prescribing, and ordering. The result iZed drug products. ing customiZed drug product can facilitate compliance and reduce the number of drug products administered per day. BACKGROUND ART [0009] Some embodiments of the present invention provide an API module, comprising: at least one excipient in a ?rst [0003] Pharmaceutical products for use in humans or ani ?xed amount, and at least one active pharmaceutical ingredi mals are produced primarily in tWo Ways. High volume or ent in a second ?xed amount of at least a dose escalation high priced drugs are manufactured under very tightly con interval or a fraction thereof. In other embodiments, the sec trolled conditions With detailed speci?cations, quality test ond ?xed amount can be greater than the dose escalation ing, and documentation. Because of the high cost and com interval. In still other embodiments, the second ?xed amount plexity of this type of pharmaceutical manufacturing, loW can be less than a dose of the at least one active pharmaceu volume, highly specialiZed drugs are produced in a cottage tical ingredient. Additional embodiments provide the second industry of compounding pharmacies. These pharmacies mix ?xed amount being less than the minimum dose of the at least various active ingredients and excipients into an often unique one active pharmaceutical ingredient. In yet other embodi product based on a doctor’s prescription. The speci?cations, ments, methods for making at least one API module are quality testing, and documentation are often minimal or non provided. Such methods comprise, in some embodiments,
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