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
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/2833—Organic macromolecular compounds
  • A61K9/2873—Proteins, e.g. gelatin
• • 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
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
  • A61J3/005—Coating of tablets or the like
• • 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
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/282—Organic compounds, e.g. fats
• • 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
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/282—Organic compounds, e.g. fats
  • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof

Definitions

• ABSTRACT A sugar-coated tablet characterized by high stability is prepared by a simple and commercially feasible procedure. The tablet is prepared by applying to the tablet core an aqueous sugar solution containing calcium lactate.
• the present invention relates to a method of coating tablets, or the like, by applying thereto a sugar coating composition comprising an aqueous sugar solution containing calcium lactate.
• Sugar-coated tablets are widely used owing to the remarkable excellency in taste, odor and appearance as compared with tablet cores and such tablets have the effect of preventing medicaments, and the like, which are present in the tablets from being decomposed by air or moisture.
• such tablets are characterized by the following shortcomings:
• the sugar-coated tablets tend to crack during storage.
• the color of the sugar-coated tablets tends to fade by exposure to temperature, humidity, light, etc.
• the main point of this invention is to make it possible to substantially reduce the production time and thereby reduce labor costs involved in the production of sugarcoated tablets by using a coating solution having a single component without forming sugar coatings involving the successive use of several kinds of coating solutions, each of such solutions having a different composition.
• Another object of this invention is to provide sugarcoated tablets characterized by l an acceptable disintegration time, (2) freedom from cracks, and substantially stable on prolonged storage that is, resistant to surrounding or environment conditions such as temperature, moisture, and light, the aforesaid characteristics being far superior to conventional sugar-coated tablets.
• a further object of this invention is to make it possible to apply directly, a sugar coating composition, to tablet cores, without requiring such pre-treatments as sealing, and the like, to the tablet cores, prior to the application of sugar coating to the tablet cores.
• the present invention is based on the novel and highly surprising and unexpected discovery that when a sugar syrup containing calcium lactate is allowed to stand, fine crystals of sugar are precipitated and the whole syrup is uniformly solidified.
• the present invention has many merits and among them some remarkable advantages as will be described hereinafter.
• the sugar-coated tablets prepared according to the method of this invention are superior in impact resistance and humidity resistance to present sugar-coated tablets. Also, the disintegration rate of the sugar-coated tablet immediately after the production thereof is remarkably faster than those produced by conventional procedures and even when the sugar-coated tablets which are obtained by the process of this invention are stored under severe or unusual conditions, the disintegration time is substantially unaffected as said disintegration time is comparable to that noted with respect to sugar-coated tablets tested shortly after they were produced.
• the coating step is conducted by using a single coating composition and it is unnecessary to utilize the conventional manual steps described supra as the composition and the amount of each coating solution is in order to effect each of the conventional manual steps including the undercoating and intermediate coating operations such as sealing, subcoating, rounding and smoothing and the coloring operation. Accordingly, by the method of this invention, the coating operation is simplified and the coating operation is completely automatized at a high speed. Moreover, by the method of this invention, the thickness of the sugar coating layer is sufficient even if it is only about one-half of the thickness of the tablet obtained by conventional procedures is reduced as well as the period of time necessary for forming the sugar coating which is usually shorter than 12 hours.
• sugar-coated tablets obtained show less deviation in weight that is, they are of more uniform weight and are uniform in size. Further, the rate of rejection or percent rejection of the sugarcoated tablets at heat sealing package is low, making the present process most suitable and desirable for commercial production.
• calcium lactate is a compound which is acceptable as an additive for foods and provides no physiological difficulties.
• the tablet cores or similar materials to be applied with sugar coating by the method of this invention may be produced in any desired size and shape such as in disc form, doughnut form, spindle form, granular form, etc.
• sugars such as sucrose, mannitol, sorbitol, etc. may be used and an aqueous solution of sucrose of about'40 to 70 percent is usually used.
• the amount of calcium lactate added to the aqueous sucrose solution is less than about 40 percent.
• favorable results can be obtained when a coating solution prepared by adding about 3 to 20 percent calcium lactate to about a 60 to 70 percent aqueous sucrose solution is used.
• a tasting agent, a flavoring agent, a colorant, an opaquing agent, a thickening agent, etc. may be desirably added to the coating solution.
• the coating solution heated ordinarily to about 60C was sprayed onto the tablet cores in a coating pan in rotation so that the coating solution was uniformly applied and the tablet cores were dried by applying warm blasts of air while rotating the coating pan.
• a so-called pausing operation of rotating a coating pan without applying a warm blast of air after applying a coating solution over the tablet cores which is always employed in a conventional sugar coating step, is unnecessary.
• Distilled water was heated to a temperature of higher than 80C and while stirring, gelatin, sucrose, calcium lactate, and tartrazine were successively added to the distilled water. Thereafter, the fine particles of polytetrafluoroethylene and talc were uniformly dispersed in the aqueous solution to provide a coating composition.
• sugar-coated tablets each having a weight of 260mgs were obtained, over a period of about 10 hours.
• Distilled water was heated to a temperature of higher than 80C and while stirring the distilled water, sucrose, sucrose distearate, calcium lactate, and tartrato percent sugar and 3 to 20% calcium lactate.
• a tablet according to claim 1 wherein the sugar is sucrose.

Landscapes

• Health & Medical Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Epidemiology (AREA)
• Engineering & Computer Science (AREA)
• Medicinal Preparation (AREA)

Applications Claiming Priority (1)

Publications (1)

Family

ID=13815937

Family Applications (1)

Country Status (12)

Cited By (22)

Families Citing this family (5)

Citations (4)

• 1970
  • 1970-09-25 JP JP45083917A patent/JPS4837815B1/ja active Pending
• 1971
  • 1971-09-17 GB GB4354371A patent/GB1346213A/en not_active Expired
  • 1971-09-20 DE DE2146859A patent/DE2146859C3/de not_active Expired
  • 1971-09-20 CH CH1373871A patent/CH566137A5/xx not_active IP Right Cessation
  • 1971-09-21 CA CA123292A patent/CA968708A/en not_active Expired
  • 1971-09-23 FR FR7134283A patent/FR2108470A5/fr not_active Expired
  • 1971-09-23 BE BE772957A patent/BE772957A/xx unknown
  • 1971-09-24 NL NL7113202A patent/NL7113202A/xx not_active Application Discontinuation
  • 1971-09-24 DK DK466671AA patent/DK128516B/da unknown
  • 1971-09-24 SE SE7112099A patent/SE373498B/xx unknown
  • 1971-09-24 SU SU1703324A patent/SU522772A3/ru active
  • 1971-09-24 US US00183635A patent/US3798054A/en not_active Expired - Lifetime

Patent Citations (4)

Non-Patent Citations (1)

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