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WO2007109684A2 - Système d'emballage sous forme de doses utilisé pour l'administration d'une formulation liquide à titrage charge-dose - Google Patents

Système d'emballage sous forme de doses utilisé pour l'administration d'une formulation liquide à titrage charge-dose Download PDF

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Publication number
WO2007109684A2
WO2007109684A2 PCT/US2007/064439 US2007064439W WO2007109684A2 WO 2007109684 A2 WO2007109684 A2 WO 2007109684A2 US 2007064439 W US2007064439 W US 2007064439W WO 2007109684 A2 WO2007109684 A2 WO 2007109684A2
Authority
WO
WIPO (PCT)
Prior art keywords
dose
package system
load
ampoules
liquid formulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/064439
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English (en)
Other versions
WO2007109684A3 (fr
Inventor
W. Randolph Warner
Daniel J. Fry
Werner Gutmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PRE Holding Inc
Original Assignee
PRE Holding Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by PRE Holding Inc filed Critical PRE Holding Inc
Publication of WO2007109684A2 publication Critical patent/WO2007109684A2/fr
Publication of WO2007109684A3 publication Critical patent/WO2007109684A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0046—Cups, bottles or bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2577/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks, bags
    • B65D2577/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D2577/041—Details of two or more containers disposed one within another
    • B65D2577/042—Comprising several inner containers
    • B65D2577/043—Comprising several inner containers arranged side by side

Definitions

  • the invention generally relates to a dose packaging system for the administration of a liquid formulation to a patient requiring load-dose titration therapy of a pharmaceutically active drug, such as steroid therapy. More particularly, the invention relates to a dose packaging system for administering titration therapy of liquid formulations to a patient which eliminates the disadvantages that are associated with cups, dosing spoons, calibrated oral syringes and bottles.
  • asthma is the most common chronic illness affecting children. At least one-third of the 24.7 million people diagnosed with asthma are children under the age of 18. Asthma is the third leading cause of hospitalization among children under age 15 and leads to 14 million days of missed school each year. This condition can also negatively affect children's academic performance because of doctor visits during school hours, lack of concentration while at school because of nighttime attacks, and decreased attentiveness or involvement at school because of the side effects of some medications.
  • oral steroids are often administered as treatment for children afflicted with asthma. Oral corticosteroids may be given early during an acute asthma exacerbation (i.e., within 45 minutes of the onset of symptoms) to reduce the likelihood of hospital admission.
  • oral corticosteroids may be more effective than inhaled or nebulized corticosteroids in children hospitalized with severe acute asthma.
  • Repeated short courses of oral corticosteroids, at a dose of 1 mg per kg per day, in the treatment of acute flares of asthma do not appear to cause any lasting changes in bone metabolism, bone mineralization, or adrenal function.
  • intravenous corticosteroids are any more effective than oral corticosteroids in children with an intact and functioning digestive tract.
  • Pediatric liquid medicines may be given with a variety of dosing instruments: plastic medicine cups, hypodermic syringes without needles, oral syringes, oral droppers, and cylindrical dosing spoons. Whether the dosing instruments measure teaspoons, tablespoons, ounces, or milliliters, these dosing instruments are preferable to using regular tableware to administer medicines because one type of tableware teaspoon may differ substantially in size from another.
  • the invention satisfies the above needs by providing a dose packaging system including pre-filled ampoules for accurate load-dose titration administration of oral steroids to children afflicted with a condition, such as asthma.
  • a dose packaging system for administering load-dose titration therapy to a patient afflicted with a condition.
  • the packaging system includes a plurality of ampoules containing a pharmaceutically effective dose of a liquid formulation and a backing card.
  • the ampoule may be a blow-fill seal vial and may be fabricated from plastic.
  • the backing card may include two or more sections containing an appropriate number of ampoules such that each section of the backing card corresponds to a daily dose of the liquid formulation to be administered to the patient and furthermore, at least one of the sections has a different number of ampoules than at least one other section.
  • the package system may further include a cover sheet to retain the ampoules onto the backing card.
  • the cover sheet may transparent, opaque, or UV resistant.
  • the cover sheet may be a skin package or the cover sheet may be a shrink package.
  • the backing card may have a weakened portion along the perimeter of the ampoules.
  • the weakened portion may be a perforated region.
  • the backing card may be composed of cardboard.
  • the load-dose titration therapy is load-dose upward titration therapy.
  • the load-dose titration therapy is load-dose downward titration therapy.
  • the load-dose therapy may be a 5 day, 6 day, 7 day, 8 day, 9 day, 10 day, 20 day or 30 day regimen.
  • the load-dose therapy is a 5 day regimen. More specifically, the load dose therapy is a 6 day therapy regimen.
  • the liquid formulation includes an effective amount of prednisolone.
  • the ampoules may be filled with about 5 ml of a liquid formulation. Moreover, the ampoules may be filled with about 2.5 ml of a liquid formulation.
  • the patient may be afflicted with a condition such as asthma, acute lower respiratory tract infection, pneumonia, infant respiratory distress syndrome, adult respiratory distress syndrome, croup, bronchitis, and pertussis.
  • FIGURE 1 is a schematic showing a dose packaging system of the invention containing a 5 day load dose downward titration of a liquid formulation of prednisolone, according to principles of the invention.
  • FIGURE 2 is a schematic showing a dose packaging system of the invention containing a 5 day load dose upward titration of a liquid formulation of prednisolone, according to principles of the invention.
  • FIGURE 3 is a schematic showing a dose packaging system of the invention containing a 6-day load-dose downward titration of a liquid formulation of prednisolone, according to principles of the invention.
  • FIGURE 4 is a front view of a skin or shrink ampoule package.
  • FIGURE 5 is a sectional view of Figure 4.
  • any numerical values recited herein include all values from the lower value to the upper value in increments of one unit provided that there is a separation of at least two units between any lower value and any higher value.
  • concentration of a component or value of a process variable such as, for example, osmolality, temperature, pressure, time and the like, is, for example, from 1 to 90, specifically from 20 to 80, more specifically from 30 to 70, it is intended that values such as 15 to 85, 22 to 68, 43 to 51, 30 to 32 etc., are expressly enumerated in this specification.
  • one unit is considered to be 0.0001, 0.001, 0.01 or 0.1 as appropriate.
  • active agent drug
  • drug pharmacologically active agent
  • chemical material or compound which, when administered to an organism (human or animal) induces a desired pharmacologic effect. Included are derivatives and analogs of those compounds or classes of compounds specifically mentioned that also induce the desired pharmacologic effect.
  • pharmaceutically acceptable carrier a material or materials that are suitable for drug administration and not biologically or otherwise undesirable, i.e., that may be administered to an individual along with an active agent without causing any undesirable biological effects or interacting in a deleterious manner with any of the other components of the pharmaceutical formulation in which it is contained.
  • a "pharmacologically acceptable” salt, ester or other derivative of an active agent as provided herein is a salt, ester or other derivative that is not biologically or otherwise undesirable.
  • an effective amount or “therapeutically effective amount” of an agent as provided herein are meant a nontoxic but sufficient amount of the agent to provide the desired therapeutic effect. The exact amount required will vary from subject to subject, depending on the age, weight, and general condition of the subject, the severity of the condition being treated, the judgment of the clinician, and the like. Thus, it is not possible to specify an exact “effective amount.” However, an appropriate “effective” amount in any individual case may be determined by one of ordinary skill in the art using only routine experimentation.
  • treating and “treatment” as used herein refer to reduction in severity and/or frequency of symptoms, elimination of symptoms and/or underlying cause, prevention of the occurrence of symptoms and/or their underlying cause, and improvement or remediation of damage.
  • the present method of "treating" asthma encompasses both prevention of asthma in a predisposed individual and treatment of asthma in a clinically symptomatic individual.
  • condition referring to a physiological state that can be prevented or treated by administration of a pharmaceutical formulation as described herein.
  • exemplary diseases and conditions may include, but not limited to, asthma, acute lower respiratory tract infection, pneumonia, infant respiratory distress syndrome, croup, bronchitis, and pertussis.
  • the term "patient” as in treatment of "a patient” refers to a mammalian individual afflicted with or prone to a condition, disease or disorder as specified herein, and includes both humans and animals.
  • the term "ampoule” as used herein generally refers to a container for aseptic or sterile compositions in the pharmaceutical and biological industries. Product information such as batch number and expiration date may be printed on the ampoule directly, or on a paper or plastic label which is then affixed to the body of the ampoule surface. Additionally, the term “ampoule” as used herein may generally refer to a blow-fill seal vial.
  • the invention relates to a dose packaging system for administration of liquid formulations to a patient which eliminates the disadvantages that are associated with cups, spoons and bottles.
  • the dose packaging system of the invention may include pre- filled blow ampoules containing the desired liquid formulation thereby eliminating the need to measure and preventing spilling and inaccuracy in dose amount administered to the patient. Additionally, ampoules included in the dose packaging system of the invention may be disposable thereby providing a more sterile administration of the liquid formulation.
  • a dose packaging system which defines a course of therapy to be administered to a patient.
  • the dose packing system of the invention may define a course of therapy such as load-dose titration therapy of a pharmaceutically effective amount of a drug in a liquid formulation to a patient afflicted with a disease requiring load dose titration therapy.
  • the liquid formulation may be in the form of syrup, an aqueous solution or a reconstituted powder in a water solution which may include a buffer to regulate the pH of the solution and a complexing agent to prevent the formation of insoluble complexes of the drug.
  • Figure 1 which illustrates an embodiment of the invention, shows a load- dose downward titration of a liquid formulation, such as prednisolone.
  • Figure 1 shows package 10 containing sections 20, 21, 22, 23, and 24 accommodating a varying number of blow-filled ampoules 30.
  • package 10 may be flexible and may provide one or more chambers inside each of section 20-24 to accommodate ampoules 30. The chambers may be compressed to allow the ampoule to be released from the package.
  • Ampoules 30 may be pre-filled with a particular amount of a liquid formulation containing the pharmaceutically active drug. For example, ampoules 30 may be pre-filled with 5 ml of prednisolone or 2.5 ml of prednisolone.
  • liquid formulations suitable for load-dose titration therapy provided in ampoules 30 will vary according to factors such as the active ingredient or ingredients, amount of time the formulation will be stored, conditions under which it will be stored and used, including the dosage form of the composition, and the particular patient population to which it may be administered. Adjustments to the formulation by adjusting constituents of the formulations and their relative concentrations, including the amounts of the drug, may be made as needed according to the needs of the formulator, administrator or patient. [0035] Turing back to Figure 1, each individual section 20-24 and the ampoules contained within each section may correspond to the daily dose of a liquid formulation that may be administered to the patient requiring load-dose titration therapy.
  • section 20, containing 4 ampoules may correspond to the dose to by administered to the patient on day 1;
  • section 21, containing 4 ampoules may correspond to the dose to be administered to the patient on day 2;
  • section 22, containing 3, ampoules may correspond to the dose to be administered on day 3;
  • section 23, containing 2 ampoules may correspond to the dose to be administered on day 4;
  • section 24, containing 1, ampoule may correspond to the dose to administered on day 5.
  • the regimen course of the load-dose titration therapy should not be construed to be limited to the five day regimen illustrated in Figure 1.
  • the course of load- dose titration therapy defined by dose packaging system of the invention may vary according to factors such as the pharmaceutically active drug included in the liquid formulation contained within the ampoule, and the particular patient population to which it may be administered. Adjustments to the therapy regimen may be made according to the needs of the formulator, administrator or patient.
  • the dose packing system of the invention may define a 5 day, 6, day, 7 day, 8 day, 9 day, 10 day, 20 day, and 30 day course of therapy, for example.
  • the titration therapy defined by the dose packaging system of the invention may include load-dose downward titration as well as load-dose upward titration or a combination of load dose upward and load dose downward titration.
  • FIG. 2 illustrates an example of an upward load-dose titration therapy.
  • each individual section 40-44 and the ampoules 50 contained within each section may correspond to the daily dose of a liquid formulation that may be administered to the patient requiring load-dose titration therapy.
  • section 40 containing 1 ampoule
  • section 41 containing 2 ampoules
  • section 42 containing 3, ampoules may correspond to the dose to be administered on day 3
  • section 43 containing 4 ampoules, may correspond to the dose to be administered on day 4
  • section 44, containing 5, ampoules may correspond to the dose to administered on day 5.
  • Figure 3 is a schematic showing a box configuration 300 for a 6 day load-dose downward titration.
  • each individual compartment 304, 306, 308, 310, 312, and 314 and the ampoules 302 contained within each compartment may correspond to the daily dose of a liquid formulation that may be administered to the patient requiring load-dose titration therapy.
  • compartment 304 containing 4 ampoules 302, may correspond to the dose to by administered to the patient on day 1 ; compartment 306, containing 4 ampoules 302, may correspond to the dose to be administered to the patient on day 2; compartment 308, containing 3 ampoules 302 may correspond to the dose to be administered to the patient on day 3; compartment 310, containing 3 ampoules 302, may correspond to the dose to be administered to the patient on day 4; compartment 312, containing 2 ampoules 302, may correspond to the dose to be administered to the patient on day 5, and compartment 314, containing 1 ampoule 302, may correspond to the dose to be administered to the patient on day 6.
  • the ampoules of the invention may be made from glass, plastic, or any other suitable material known by those of skill in the art.
  • the ampoules may be plastic blow-fill seal vial.
  • the ampoules may be mounted on a backing card with a cover sheet.
  • the backing card may be cardboard, for example, and may provide a surface area on which to display product information.
  • product name, manufacturer, batch number and product expiration date can be readily printed on the peripheral flange portion surrounding the ampoule, and the instruction for opening the package or using the contents can be printed on the front or rear side of the backing card.
  • the backing card may be manufactured in strips with a scored or perforated weakened section between adjacent packages.
  • the cover sheet may be transparent so that the user can conveniently inspect the appearance of the ampoule contents. If the ampoule contents are light sensitive, an opaque or ultraviolet absorbing cover sheet material may be used. In the packaging arts, the package containing the ampoule would generally be referred to as a skin, shrink, or blister package.
  • skin packaging may be employed.
  • Skin packaging generally refers to a package comprising an air pervious backing card upon which the ampoule may be supported by a relatively thin thermoplastic film which is softened by heating. Suction may be drawn through the backing card to draw the heat softened film into a sheath or "skin" about the ampoule and into contact with the backing card.
  • the cover sheet can be attached to the backing card by an adhesive material or heat sealing.
  • shrink packaging may be used as a substitute for skin packaging when the active ingredient is heat sensitive.
  • Shrink packaging generally refers to the technique where the plastic film is first stretched, while hot, to form a relatively large cavity to accommodate the ampoule. After the ampoule has been positioned in the cavity the film is heated to shrink it into tight abutment with the product. This method may be used to skin packaging if the pharmaceutical composition in the ampoule is heat sensitive.
  • a blister or bubble package generally includes a cup which may be molded from a relatively heavy plastic film and is contoured to the shape of the article. This cup, known as a bubble or blister, provides a preformed cavity of sufficient size to receive the ampoule.
  • the bubble is formed with a peripheral flange so that it can be attached to the backing card by an appropriate means, such as heat fusion or a heat-sealed coating.
  • Figures 4 and 5 show an ampoule 402 in a skin or shrink package 400, according to an embodiment of the invention.
  • the package includes a backing card 500 and a pliable transparent cover sheet 502 which forms a sheath over the ampoule.
  • the ampoule is filled with a solution containing the desired active ingredient 504 and includes a container portion 506 and a tip portion 508.
  • the backing card may be perforated along the perimeter of the ampoule so the ampoule may be easily removed from the package for use by the caregiver or patient.
  • Exemplary compounds for use in the invention may include but not limited to, alprazolam; amoxapine; atropine; bumetanide; buprenorphine; butorphanol; clomipramine; donepezil; hydromorphone; loxapine; midazolam; morphine; nalbuphine; naratriptan; olanzapine; paroxetine; pramipexole; prochlorperazine; quetiapine; rizatriptan; sertraline; sibutramine; sildenafil; sumatriptan; tadalafil; vardenafil; venlafaxine; Zolpidem; apomorphine HCl; celecoxib; ciclesonide; eletriptan; parecoxib; valdecoxib; fentanyl; citalopram; escitalopram; clonazepam; oxymorphone; alb
  • the active compounds which may be applicable for load-dose titration therapy may include substances selected from the groups of anti- inflammatory compounds, anti-allergies, glucocorticoids, anti-infective agents, antibiotics, antifungals, antivirals, mucolytics, antiseptics, vasoconstrictors, wound healing agents, local anaesthetics, peptides, and proteins.
  • Examples of potentially useful anti-inflammatory compounds that may be applicable for load-dose titration therapy may include glucocorticoids and non-steroidal anti-inflammatory agents such as betamethasone, beclomethasone, budesonide, ciclesonide, dexamethasone, desoxymethasone, fluoconolone acetonide, flucinonide, flunisolide, fluticasone, icomethasone, rofleponide, triamcinolone acetonide, fluocortin butyl, hydrocortisone, hydroxycortisone-17-butyrate, prednicarbate, 6-methylprednisolone aceponate, mometasone furoate, elastane, prostaglandin, leukotriene, bradykinin antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indometacin, including any pharmaceutically acceptable salts, esters, iso
  • Examples of potentially useful antiallergic agents applicable for load-dose titration therapy may include glucocorticoids, nedocromil, cetrizin, loratidin, montelukast, roflumilast, ziluton, omalizumab, heparinoids and other antihistamins, Azelastine, Cetirizin, Desloratadin, Ebastin, Fexofenadin, Levocetirizin, Loratadin.
  • phenoxypenicillins penicillin V, propicillin
  • aminoberi2ylpenicillins amoxycillin, bacampicillin
  • acylaminopenicillins azlocillin, mezlocillin, piperacillin, apalcillin
  • carboxypenicillins carbenicillin, ticarcillin, temocillin
  • isoxazolyl penicillins oxacillin, cloxacillin, dicloxacillin, flucloxacillin
  • amiidine penicillins mecillinam
  • cephalosporins including cefazolins (cefazolin, cefazedone); cefuroximes
  • Examples of potentially useful mucolytics that may be useful for load-dose titration therapy may be DNase, P2Y2-agonists (denufosol), heparinoids, guaifenesin, acetylcysteine, carbocysteine, ambroxol, bromhexine, lecithins, myrtol, and recombinant surfactant proteins.
  • Examples of potentially useful local anaesthetic agent which may be suitable for load-dose titration therapy may include benzocaine, tetracaine, procaine, lidocaine and bupivacaine.
  • drugs to treat pulmonary hypertension such as prostacycline analogs, iloprost, remodulin, phosphodiesterase inhibitors, such as sildenafil, vardenafil, endothelian recector antagonists, such as bosentane, virustatics, including podophyllotoxine, vidarabine, tromantadine, zidovudine; ribavirin, may be applicable for load-dose titration therapy.
  • immunmodulators may be suitable for load-dose titration therapy may include methotrexat, azathioprine, cyclosporine, tacrolimus, sirolimus, rapamycin, mofetil, cytotatics and metastasis inhibitors, alkylants, such as nimustine, melphanlane, carmustine, lomustine, cyclophosphosphamide, ifosfamide, trofosfamide, chlorambucil, busulfane, treosulfane, prednimustine, thiotepa; antimetabolites, e.g.
  • cytarabine fluorouracil, methotrexate, mercaptopurine, tioguanine; alkaloids, such as vinblastine, vincristine, vindesine; antibiotics, such as alcarubicine, bleomycine, dactinomycine, daunorubicine, doxorubicine, epirubicine, idarubicine, mitomycine, plicamycine; complexes of secondary group elements (e.g.
  • Ti, Zr, V, Nb, Ta, Mo, W, Pt such as carboplatinum, cis-platinum and metallocene compounds such as titanocendichloride; amsacrine, dacarbazine, estramustine, etoposide, beraprost, hydroxycarbamide, mitoxanthrone, procarbazine, temiposide; paclitaxel, iressa, zactima, poly-ADP-ribose-polymerase (PRAP) enzyme inhibitors, banoxantrone, gemcitabine, pemetrexed, bevacizumab, ranibizumab.
  • PRAP poly-ADP-ribose-polymerase
  • other active ingredient that may used in load-dose titration therapy may include, proteinase inhibitors, such as ⁇ -anti-trypsin; antioxidants, such as tocopherols, glutathion; pituitary hormones, hypothalamic hormones, regulatory peptides and their inhibiting agents, corticotropine, tetracosactide, choriogonandotropine, urofolitropine, urogonadotropine, saomatotropine, metergoline, desmopressine, oxytocine, argipressine, ornipressine, leuproreline, triptoreline, gonadoreline, busereline, nafareline, goselerine, somatostatine; parathyroide gland hormones, calcium metabolism regulators, dihydrotachysterole, calcitonine, clodronic acid, etidronic acid; thyroid gland therapeutics; sex hormones and
  • epoetine and peptides, e.g. parathyrin, somatomedin C; heparine, heparinoids, urokinases, streptokinases, ATP-ase, prostacycline, sexual stimulants, or genetic material.
  • peptides e.g. parathyrin, somatomedin C; heparine, heparinoids, urokinases, streptokinases, ATP-ase, prostacycline, sexual stimulants, or genetic material.
  • Additional constituent elements of the liquid formulations of the invention may include water, a buffer, a pH-adjusting agent, a surfactant or anti-adsorbant, a wetting agent, a gelling agent, a drying agent, an osmolality adjusting agent, or virtually any other additive or carrier, depending upon the desired dosage form.
  • the liquid formulations may be modified to accommodate the particular pharmaceutically effective drug and the particular patient population the liquid formulation is administered to.
  • Formulation characteristics that may be modified include, for example, the pH and the osmolality.
  • polymeric excipients may be useful in the liquid formulations of the invention, for among other things, to obtain slow release profile of the drug, such as chitosan, hydroypropylmethylcellulose, dextrans, and kollidon.
  • Buffers may be useful in the invention for, among other purposes, manipulation of the total pH of the liquid formulation.
  • a variety of buffers known in the art may be used in the formulation of the invention, such as various salts of organic or inorganic acids, bases, or amino acids, and including various forms of citrate, phosphate, tartrate, succinate, adipate, maleate, lactate, acetate, bicarbonate, or carbonate ions.
  • the pH of the formulation changes according to the amount of buffer used. Depending upon the dosage form it may alternatively be advantageous to use buffers in different concentrations or to use other additives to adjust the pH of the formulation to encompass other ranges.
  • Useful pH ranges for formulations of the invention include a pH of about 4.0 to a pH of about 7.0.
  • surfactants or anti-adsorbants that prove useful include polyoxyethylenesorbitans, polyoxyethylenesorbitan monolaurate, polysorbate-20, such as Tween-20TM, polysorbate-80, hydroxycellulose, and genapol, vitamin E-TPGS and lecithins or lecithin constituents.
  • Additional useful additives are readily determined by those of skill in the art, according to particular needs or intended uses of the compositions and formulator.
  • One such particularly useful additional substance is sodium chloride, which is useful for adjusting the osmolality of the formulations to achieve the desired resulting osmolality.
  • Particularly preferred osmolalities for administration of the liquid formulations of the invention are in the range of about 200 to about 400 mOsm/kg.

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Abstract

L'invention concerne des systèmes d'emballages sous forme de doses, destinés à l'administration d'une formulation liquide à un patient nécessitant une thérapie à titrage charge-dose d'un médicament pharmaceutiquement acceptable, telle qu'une thérapie stéroïde. L'invention concerne, en particulier, un système d'emballage sous forme de doses utilisé pour l'administration d'une thérapie comprenant le titrage de formulations liquides à un patient, ceci permettant d'éliminer les désavantages inhérents aux tasses, aux cuillers-doses, aux seringues orales calibrées et aux bouteilles.
PCT/US2007/064439 2006-03-20 2007-03-20 Système d'emballage sous forme de doses utilisé pour l'administration d'une formulation liquide à titrage charge-dose Ceased WO2007109684A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US78340106P 2006-03-20 2006-03-20
US60/783,401 2006-03-20

Publications (2)

Publication Number Publication Date
WO2007109684A2 true WO2007109684A2 (fr) 2007-09-27
WO2007109684A3 WO2007109684A3 (fr) 2008-03-06

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/064439 Ceased WO2007109684A2 (fr) 2006-03-20 2007-03-20 Système d'emballage sous forme de doses utilisé pour l'administration d'une formulation liquide à titrage charge-dose

Country Status (2)

Country Link
US (1) US20080000798A1 (fr)
WO (1) WO2007109684A2 (fr)

Cited By (1)

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CN108470643A (zh) * 2018-03-29 2018-08-31 渤海大学 一种金刚烷胺类超级电容器电解液的制备方法

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US20100219728A1 (en) * 2009-02-27 2010-09-02 Richard Wolpow Quick dispense system
WO2007120666A1 (fr) 2006-04-10 2007-10-25 Aeiomed, Inc. Appareil et procédés pour fournir de l'humidité dans un traitement respiratoire
US20070295060A1 (en) * 2006-06-13 2007-12-27 Delgado Juan C Ampoule card leak detector assembly
EP2082717A1 (fr) * 2008-01-28 2009-07-29 Merz Pharma GmbH & Co. KGaA Ensemble de titration
FR2969486B1 (fr) * 2010-12-24 2013-05-24 Zahar Kamal Cherif Kit pour le traitement des envenimations
US8875940B2 (en) 2011-08-09 2014-11-04 Medline Industries, Inc. Prophylactic kit apparatus
WO2013120182A1 (fr) * 2012-02-17 2013-08-22 Bernard Fresco Trousse de premiers soins pourvue d'un élément de support
US9364393B1 (en) * 2012-08-17 2016-06-14 Healthstar, Inc. Packaging system for liquid medications
US20150165146A1 (en) 2013-12-17 2015-06-18 Bruce Bowman Humidification system and positive airway pressure apparatus incorporating same
BR112018071699A2 (pt) 2016-04-25 2019-02-19 Andrew Koska Marc sistema de liberação médica
WO2019099954A1 (fr) 2017-11-17 2019-05-23 Koska Family Limited Systèmes et procédés pour distributeurs de fluide
USD1052082S1 (en) 2020-06-01 2024-11-19 Koska Family Limited Sealed fluid container
USD992110S1 (en) 2021-08-10 2023-07-11 Koska Family Limited Sealed fluid container

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US4186835A (en) * 1978-10-10 1980-02-05 Interondo Ag Box for ampoules having a packaging insert that provides a closure arrangement and reinforcement
GB2101094B (en) * 1981-07-07 1984-10-24 Cito Pac Verpackungs Gmbh Blister pack strip
US4721204A (en) * 1987-01-02 1988-01-26 Shee William S Package for holding and using ampules
GB8801655D0 (en) * 1988-01-26 1988-02-24 Waverley Pharma Ltd Ampoules
US5009894A (en) * 1988-03-07 1991-04-23 Baker Cummins Pharmaceuticals, Inc. Arrangement for and method of administering a pharmaceutical preparation
DE3916840A1 (de) * 1988-09-21 1990-03-29 Bernd Hansen Ampulle
EP0539169B1 (fr) * 1991-10-22 1996-05-08 WEILER ENGINEERING Inc Article avec forme permettant de déterminer sa position; procédé et appareil pour la production et le traitement de cet article
US6571790B1 (en) * 1997-05-12 2003-06-03 Robert E. Weinstein Method and device for organizing and coordinating the combined use of liquid medications for continuous nebulization for the treatment of respiratory disorders
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108470643A (zh) * 2018-03-29 2018-08-31 渤海大学 一种金刚烷胺类超级电容器电解液的制备方法

Also Published As

Publication number Publication date
WO2007109684A3 (fr) 2008-03-06
US20080000798A1 (en) 2008-01-03

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