Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
  • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form

Definitions

• the present invention relates to a soft icecream-type pharmaceutical formulation and a process for preparing the same .
• Antipyretics, antibiotics and vitamins have been conventionally formulated in the forms of tablet, capsule, liquid, injection solution and syrup.
• the conventional dosage forms are, however, proven to be less satisfactory in the sense that they are not convenient for administering to children. Accordingly, particular attention should be paid in choosing the dosage forms, especially, orally administrable pharmaceutical formulations are selected under a careful consideration of taste and mouth feel in oral cavity.
• many medicines and active ingredients are bitter in taste or else hold uncomfortable taste, rough or chalky feeling.
• the pharmaceutical formulations of relatively easy administration for children such as chewable tablet, jelly-like tablet, granules, etc., have been developed. They are commercially available though these pharmaceutical formulations are not ideal in terms of children's affinity. Under the circumstances, there are strong reasons for exploring and developing new type of pharmaceutical formulation for children.
• the present inventors have made efforts to develop an icecream-type pharmaceutical formulation which can be applied in drugs such as antipyretics, antibiotics and vitamins, and found that it provides excellent drug absorption with improved patient's drug compliance in light of easy oral application and high affinity.
• the primary object of the present invention is, therefore, to provide an icecream-type pharmaceutical formulation.
• the other object of the invention is to provide a process for preparing the icecream-type pharmaceutical formulation.
• Another object of the invention is to provide icecream-type formulations of antipyretic, antibiotic and vitamin.
• Figure 1 is a high performance liquid chromatography chromatogram of acetaminophen in blood.
• Figure 2 is a graph showing blood level of tablet- type and icecream-type acetaminophen after oral administration.
• Icecream-type pharmaceutical formulation of the present invention is prepared by the steps of: mixing egg yolk and milk with stirring until they are completely mixed; whipping cream until it is reduced to pulp and mixing it with the said mixture in a volume ratio of 9:1 to 5:5, more preferably 8:2 to 6:4, most preferably 7:3; adding drugs into the said mixture in a ratio of 0.1 to 20wt% and blending them; and, finally putting them into an icecream maker and formulating into a pharmaceutical formula by subjecting at the temperature range of 0°C to -10°C.
• sugar and/or cocoa may be further added to the mixture of egg yolk and milk according to the patient's preference, and coconut hard fat may substitute for the egg yolk.
• the milk includes soy bean milk, processed skim milk (containing 7.2% skimmed milk powder) and plain milk.
• the cream includes: commercially available emulsion cream which can be obtained by the centrifuge of animal/vegetable oil; and, carboxymethylcellulose (CMC) solution.
• CMC carboxymethylcellulose
• the antipyretics include acetaminophen, aspirin, ibuprofen, ketoprofen and isopropyl-antipyrin, preferably acetaminophen and/or mixture thereofs
• the antibiotics include amoxicillin, ampicillin, erythromycin, lincomycin, and cefalexin, most preferably amoxicillin
• the vitamins include retinol acetate, cholecalciferol, tocopherol acetate, ascorbic acid, thiamme nitrate, riboflamin, pyridoxine hydrochloride, ⁇ icotinamide and cyanocobalamin.
• Example 1 Preparation of icecream-type formulation containing an antipyretic of acetaminophen Example 1-1
• An icecream-type antipyretic formulation was prepared in an analogous manner as in Example 1-1, except for employing the ingredients shown in Table 2 below.
• An icecream-type antipyretic formulation was prepared in an analogous manner as in Example 1-1, except for employing the ingredients shown m Table 3 below.
• An icecream-type antibiotic formulation was prepared m an analogous manner as in Example 1-1, except for employing the ingredients shown in Table 4 below.
• An icecream-type antibiotic formulation was prepared in an analogous manner as in Example 1-1, except for employing tne ingredients shown in Table 5 below.
• An icecream-type antibiotic formulation was prepared in an analogous manner as in Example 1-1, except for employing the ingredients shown in Table 6 below.
• An icecream-type multi-vitamin formulation was prepared in an analogous manner as in Example 1-1, except for employing the ingredients of retinol acetate, cholecalciferol, tocopheroi acetate, ascorbic acid, th amine nitrate, ⁇ boflavm, py ⁇ doxine hydrochlo ⁇ de, nicotinamide and cyanocobalamm as shown in Table 7 below.
• Table 7 The contents of icecream-type formulation containing vitamins
• An icecream-type multi-vitamin formulation was prepared m an analogous manner as m Example 1-1, except for employing the ingredients of retinol acetate, cholecalci erol, tocopheroi acetate, ascorbic acid, nitrate, nooflavm, py ⁇ oxine hydrochlo ⁇ de, nicotinamide and cyanocobalamm as snown in Table 8 below.
• Table 8 The contents o-i icecream-type formulation containing vitamins
• Acute toxicities of icecream-type formulations of antipyretics, antibiotics, and vitamins prepared m Examples 1, 2 and 3 were investigated by employing 5 sets of male and female rats, which revealed that no mortal rat was detected up to the level of 5g/kg/day which is 500 times of antipyretics, 5000 times of antibiotics and 50000 times of vitamins m terms of their effective amounts.
• the icecream-type formulation of present invention which comprises antipyretic, antibiotic, or vitamin as an active ingredient is formulated for orally applicable purpose, accordance with the conventional formulating method by containing surfactants, excipients, t ctorials, stabilizers, buffers, suspensions, lsotomc solution, and other additives, organic or inorganic carriers.
• the icecream-type formulation may be administered to children in an oral dosage in an amount of 2 to 20mg/kg(20kg as a standard weight), while it may be varied depending on the type o drugs, medical treatments, diseases, patient's age and duration of medication.
• the present invention provides an icecream-type pharmaceutical formulation and a process for preparing the same. Icecream-type pharmaceutical formulations prepared by the invention have higher drug compliance to children with easy administration and good absorption and thus may substitute for troches .

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Epidemiology (AREA)
• Pharmacology & Pharmacy (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Medicinal Chemistry (AREA)
• Chemical & Material Sciences (AREA)
• Zoology (AREA)
• Nutrition Science (AREA)
• Physiology (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Priority Applications (3)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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Cited By (2)

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Citations (2)

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• 1999
  • 1999-04-09 KR KR1019990012520A patent/KR20000065822A/ko not_active Application Discontinuation
• 2000
  • 2000-04-07 WO PCT/KR2000/000321 patent/WO2000061110A1/ko not_active Application Discontinuation
  • 2000-04-07 JP JP2000610443A patent/JP2002541184A/ja active Pending
  • 2000-04-07 EP EP00921116A patent/EP1089709A4/en not_active Withdrawn
  • 2000-04-07 AU AU41465/00A patent/AU4146500A/en not_active Abandoned
  • 2000-04-07 CN CN00800535A patent/CN1300208A/zh active Pending

Patent Citations (2)

Non-Patent Citations (3)

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