Package form for bicarbonate-containing powdery pharmaceutical c

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Patent

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

604416, A61J 100

Patent

active

056101708

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

The present invention relates to a method of stabilizing a bicarbonate-containing powdery pharmaceutical composition, particularly a novel method of stabilizing a bicarbonate-containing powdery pharmaceutical composition which allows the composition in a plastic container to remain wholesome without aging or degradation and the object of addition of the carbonate to be accomplished without compromise and to a package form for such bicarbonate-containing powdery pharmaceutical composition.


BACKGROUND ART

With very few exceptions such as sodium chloride, drugs are susceptible to aging loads such as water, oxygen and light and glass ampules have been in use for their storage since many years ago. However, with the recent advances in pharmaceutical science, material engineering, production methodology, production equipment, etc., these pharmaceutical containers are being replaced by glass vials and plastic (such as polyolefins, e.g. polyethylene, polypropylene, etc., ethylene-vinyl acetate copolymer, polyethylene terephthalate, polyvinyl chloride, etc.) containers which are easy for those engaged in medical practice to handle and easy to dispose of after use and the utilization of such plastic containers, in particular, is rapidly spreading of late.
However, unlike glass, plastics are inherently permeable to gas and moisture and have the disadvantage that containers made thereof cannot be used for all kinds of drugs. Recently, materials which are almost as impervious to gas and moisture as glass, such as a laminate film carrying a vapor-deposited aluminum layer or an aluminum foil, a laminate film carrying a vapor-deposited silicon monoxide layer, a multi-layer film consisting of plural materials such as polyethylene terephthalate, polyvinyl alcohol, polyvinylidene chloride, ethylene-vinyl alcohol copolymer, etc. have been developed and today plastics with an oxygen permeability rate of not more than 1.0 cc/m.sup.2 .multidot.24 hrs/1 atm. and a moisture permeability rate of not more than 1.0 g/m.sup.2 .multidot.24 hrs/1 atm. are available on the market and finding ever broadening usage and application.
Meanwhile, drugs are generally stable in the bulk form but if they are dissolved and administered to patients, the low pH values of the solutions would not only damage the local tissue at the administration site but also induce systemic disturbances or result in poor absorption. Therefore, a variety of pharmaceutical contrivances has so far been made to avoid the troubles. By way of illustration, assuming that the pharmaceutical composition contains a strongly acidic powdery substance such as the hydrochloride or an acidic powdery drug whose neutral salt would be unstable, it is common practice to formulate the drug with a bicarbonate to insure the proper pH on dissolution or convert it to the neutral salt which is more readily absorbed at the time of administration.
Moreover, drugs which are unstable in solution, for example certain antibiotics, are supplied in the powdery form but since these drugs in general are sparingly soluble in aqueous vehicles, a bicarbonate as a source of carbon dioxide gas, which assists in dissolution, is added as a solubilizer.
On the other hand, sodium hydrogen carbonate is contained as an alkalizing agent in dialysis fluid compositions for artificial kidney use and for the purpose of insuring the ease of handling and reducing the cost of shipment, the recent tread is toward converting such liquid compositions to powdery or granular preparations (e.g. Japanese Patent Application Kokai H3-38527 and Kokai H3-74331).
The bicarbonate contained in such pharmaceutical compositions liberates water and carbon dioxide gas with time but it is well known that in a closed system there is established an equilibrium among the bicarbonate, carbonate, water and carbon dioxide as indicated by the following relation (1).
However, when a bicarbonate-containing powdery pharmaceutical composition is supplied in a plastic (such as polyolefins, e.g. polyethylene, polypropylene, etc.,

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Package form for bicarbonate-containing powdery pharmaceutical c does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Package form for bicarbonate-containing powdery pharmaceutical c, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Package form for bicarbonate-containing powdery pharmaceutical c will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-443832

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.