WO1999049875A1 - The process for the preparation of a stable fixed dose pharmaceutical composition of anti infective agent/agents and micro organisms as active ingredients - Google Patents
The process for the preparation of a stable fixed dose pharmaceutical composition of anti infective agent/agents and micro organisms as active ingredients Download PDFInfo
- Publication number
- WO1999049875A1 WO1999049875A1 PCT/IB1998/000445 IB9800445W WO9949875A1 WO 1999049875 A1 WO1999049875 A1 WO 1999049875A1 IB 9800445 W IB9800445 W IB 9800445W WO 9949875 A1 WO9949875 A1 WO 9949875A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- infective agent
- infective
- tablet
- organisms
- coated
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
- A61K36/064—Saccharomycetales, e.g. baker's yeast
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
Definitions
- therapies which can be used include different kind of anti-infective agents e.g. metronidazole. vancomycin. 3*13*8 teicoplanin and/or use of organisms like lactobacilh. biofidobacterium. saccharomyies boulardili. streptococcus thermophilus, enterococcus facecium SF 68, L Casei
- Organisms used 9 eradicate or help in eradicating pathogens by variety of mechanisms which include production of hydrogen peroxide or inhibition or adherence of pathogens to intestinal cells.
- Anti-infective agents induced diarrhoea prolong treatment, increase cost of therapy by increased number of drugs to be used, 2 days of hospitalisation and Consultations. Sometimes they create life threatening situation e.g. pseudememberous colitis, 4 13*20 toxic megacolon.
- Antibiotic-associated pseudomembranous colitis retrospective study of 48 cases diagnosed by colonoscopy.
- the further objective of present invention is to minimise side effects of anti-infective agents resulting from destruction/alteration of normal flora by providing viable organisms along with anti-infective agent(s).
- the further objective of present invention is to provide a pharmaceutical composition which is effective after longer period of storage.
- the further objective of the present invention is to improve compliance by providing two drugs in one pharmaceutical composition.
- the anti-infective agent and organisms are to be identified. Their dosage route of administration and dosage form is finalised.
- the susceptible organism are combined into the formulation in such a way that organisms remain viable for the self life of a formulation inspite of being in contact with anti-infective agent.
- a protective barrier is created around organisms or anti-infective agent, in such a way that anti-infective agent cannot have effect on organisms. This results in viable organisms in presence of anti- infective agent. The organism remain viable as long as the barrier is maintained. This is like applying paint or a film on a substance to prevent corrosion by isolating it from surroundings.
- the protective barrier is selected depending on route of administration and dosage form of the pharmaceutical composition (anti-infective agent + organism)
- the pharmaceutical composition so manufactured is evaluated at different test conditions of temperature and humidity (45"C, 37°C at 80% relative humidity and ambient temperature) for time interval extending upto 12 months.
- Example XXIII Example XXIV Cephalexin 500 mgm Cefuroxime Axetil 125 mgm Probenecid 500 mgm Lactobacillus 60 million Lactobacillus 60 million
- Example XXV Example XXVI Cefuroxime Axetil 250 mgm Cefuroxime Axetil 500 mgm Lactobacillus 60 million Lactobacillus 60 million
- anti-infective agents can be used for any therapeutic purpose which in a therapeutic dosage causes significant adverse effects which can be presented by using an organism.
- the organism can be any which prevents or minimises adverse reactions of anti- infective agents when taken at same time.
- pseudomembranous colitis it can be biofidobacterium, sacchormyces streptococcus thermophilus, enterococcus etc. instead of lactobacillus in above examples in their appropriate dosages.
- Organisms can be lumped together and formulated into a tablet. The tablet coated with a barrier film. The film protected organisms are introduced into the capsule independently. Anti- infective agent is put in the capsule containing organisms protected by a barrier film. It can be vice versa. 12
- Organisms can be granulated. Granules containing organisms are coated
- Organisms are coated and compressed into a layer of tablet.
- the other layer(s) of tablet contains anti-infective agent.
- Granules of organisms are coated with barrier film and mixed with granulated material of anti-infective agents and compressed into a tablet.
- Anti-infective agents are formulated into compressed tablet. They are coated. During coating stage organisms are introduced in the coating. The coating should be capable of protecting organisms from anti-infective agents. It can be vice versa i.e. anti-infective agent is included in coating.
- Tablet with a hole is produced containing anti-infective agent.
- the hole of the tablet is filled with organisms.
- the tablet so obtained may be coated for final finishing. 13
- Coating/barrier protection is not so much necessary as it is in a capsule form as long as moisture content is controlled and physical separation is maintained in a same tablet.
- Formulated tablet can be dispersible tablet or simple tablet.
- Liquid formulations i) The organisms are coated with barrier film mixed with other ingredients (dry form) of formulation including anti-infective agent. The product is reconstituted before use by addition of adequate amount of liquid.
- the organisms are coated with barrier film and suspended in a liquid containing anti-infective agents or vice versa.
- the barrier film is stable in liquid formulation but disintegrates in body due to alteration in surrounding, e.g. pH
- a stable fixed dose combination layered tablet is prepared using the following components of which the active ingredients are anti-infective agent(s) and micro organisms. The remaining components are physiologically acceptable excipients.
- the active ingredients is coated in a coating pan by the coating process known to those skilled in the art. Excipients are also used along with one of the active ingredients (granules) during tablet making for lubrication as required for the purpose.
- Granules of separate active ingredients are first prepared by process known to those skilled in the art. The separate sets of granules are then compressed on double rotary tablet compression machine having a laying facility at a temperature below 25°C and relative humidity not more than 50% by processes known to those skilled in the art and the tablets are transferred to a coating pan for film coating to be given by using film coating process known to those skilled in the art.
- the fixed dose layered tablet composition which are prepared through making use of above described process contain the above active ingredients anti- infective agents and viable organisms in their respective therapeutic concentration.
- the composition provide pharmacological effects which are complementary to the effects produced by (Prior art) each individual ingredient and are stable for a period of atleast 3 - 36 months at ambient room temperamre.
- a stable fixed dose combination capsules are prepared using following components of which the active ingredients are anti-infective agents and micro organisms. The remaining components are physiologically acceptable excipients.
- Granules of one of the active ingredients e.g. micro organisms
- the granules so formed are compressed into a tablet by tablet compression machine heaving a laying facility at a temperamre below 25°C and relative humidity not more than 50% by process known to those skilled in the art. Tablets are transferred to a coating pan for coating to be given by coating process known to those skilled in the art.
- the remaining active ingredient is mixed with excipients and filled into gelatin capsules by process known to those skilled into the art.
- the coated tablet containing active ingredients are introduced into capsule by processes known to those skilled in the art.
- the fixed dose capsule composition which are prepared through making use of above described process contain the above active ingredients, anti infective agents and viable
- composition provide pharmacological effect which are complementary to the effects produced by (prior art) each individual ingredient and are stable for at least 3 - 36 months at ambient room temperamre.
- a stable fixed dose combination liquid tablet is prepared using the following components of which the active ingredients are anti- infective agent(s) and micro organisms.
- One of the active ingredients is granulated after suspending it in a coating suspension to provide granules of 100 micron or less in size by processes known to those skilled in art.
- Granules so prepared are suspended into a liquid formulation by processes known to those skilled in the art.
- the other active ingredient is introduced into the suspension by the process known to those skilled in the art in such a way that final concentration of micro organisms is 20% of anti infective agent(s).
- the fixed dose liquid suspension composition which is prepared through making use of above described process contain the above active ingredients, anti infective agents and viable organisms in their respective therapeutic concentrations.
- the composition provide pharmacological effect which are complementary to the effects produced by (prior art) each individual ingredient and are stable for at least 3 - 36 months at ambient room temperamre.
- a stable fixed dose combination dry powder for reconstimting liquid formulation before use is prepared using the following components of which the active ingredients are acceptable excipients.
- One of the active ingredients is granulated after suspending it in a coating suspension by process known to those skilled in the art.
- the granules so prepared are dried and mixed with dry powder containing another active ingredient by processes known to those skilled in the art in such a way that micro organisms are 20% of anti infective agent(s) by weight.
- the relative propo ⁇ ion of anti infective agents and the excipients to prepare coated granules is as follows :
- the fixed dose dry powder composition which are prepared through making use of above described process contain the above active ingredients, anti infective agents and viable organisms in their respective therapeutic concentrations.
- the composition provide pharmacological effect which are complementary to the effects produced by (prior an) each individual ingredient and are stable for at least 3 - 36 months at ambient room temperamre.
- composition when reconstituted by adding liquid prior to use remains stable at ambient room temperamre for 3 to 7 days.
- Anti infective agents can be penicillins e.g. ampicillin. amoxycillin. cloxacillin, cephalosporins e.g. cephalexin, cefadroxvl, cefuroxime axetil, cefixime, beta lactamase inhibition like clauvanic acid - macrolide like erythromycin as single ingredient or combination thereof.
- Solid dosage forms like capsules or tablet contains anti infective agents equivalent to 125, 250 or 500 mgm of active component
- Liquid dosage forms usually contains anti infective agents equivalent to 125 mgm of active component in 5 ml.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Organic Chemistry (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
UA99116272A UA59394C2 (en) | 1998-03-27 | 1998-03-04 | Process of preparing stable fixed dose composition of anti-infective agent with microorganisms as active ingredients |
JP54906699A JP2002516616A (en) | 1998-03-27 | 1998-04-03 | Process for the preparation of a stable fixed dose pharmaceutical composition comprising one or more anti-infective drugs and microorganisms as active ingredients |
CA002291780A CA2291780A1 (en) | 1998-03-27 | 1998-04-03 | The process for the preparation of a stable fixed dose pharmaceutical composition of anti infective agent/agents and micro organisms as active ingredients |
APAP/P/1999/001724A AP9901724A0 (en) | 1998-03-27 | 1998-04-03 | Process for the preparation of astable fixed dose pharmaceutical composition of anti-infective agent/ agents and microorganisms as active ingredients. |
EP98909680A EP0998295A1 (en) | 1998-03-27 | 1998-04-03 | The process for the preparation of a stable fixed dose pharmaceutical composition of anti infective agent/agents and micro organisms as active ingredients |
EA199900938A EA002148B1 (en) | 1998-03-27 | 1998-04-03 | The process for the preparation of a stable fixed dose pharmaceutical compositionof anti infectiveagent/agents and micro organisms as active ingredients |
IDW991648A ID26341A (en) | 1998-03-27 | 1998-04-03 | PROCESS FOR PROVIDING DOSAGE STABLE COMPOSITION OF ANTI-INFECTION AND MICROORGANISM SUBSTANCE AS ACTIVE DRUG MATERIALS |
AU64156/98A AU770024B2 (en) | 1998-03-27 | 1998-04-03 | The process for the preparation of a stable fixed dose pharmaceutical composition of anti infective agent/agents and micro organisms as active ingredients |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB9806489.2A GB9806489D0 (en) | 1998-03-27 | 1998-03-27 | The process for the preparation of a stable fixed dose pharmaceutical composition of anti-infective agent/agents and micro organisms as active ingredients |
LK1644598 | 1998-03-27 | ||
LKB16445 | 1998-03-27 | ||
GB9806489.2 | 1998-03-27 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999049875A1 true WO1999049875A1 (en) | 1999-10-07 |
Family
ID=26313367
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB1998/000445 WO1999049875A1 (en) | 1998-03-27 | 1998-04-03 | The process for the preparation of a stable fixed dose pharmaceutical composition of anti infective agent/agents and micro organisms as active ingredients |
Country Status (9)
Country | Link |
---|---|
EP (1) | EP0998295A1 (en) |
JP (1) | JP2002516616A (en) |
AP (1) | AP9901724A0 (en) |
AU (1) | AU770024B2 (en) |
CA (1) | CA2291780A1 (en) |
EA (1) | EA002148B1 (en) |
ID (1) | ID26341A (en) |
UA (1) | UA59394C2 (en) |
WO (1) | WO1999049875A1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011033310A1 (en) * | 2009-09-17 | 2011-03-24 | William John Martin | Encapsulated intestinal flora extracted from feces for use in the treatment of gastrointestinal disorders |
WO2011086575A2 (en) * | 2010-01-13 | 2011-07-21 | Toyochem Laboratories | A pharmaceutical composition for treatment of respiratory tract infections |
WO2020164788A1 (en) * | 2019-02-13 | 2020-08-20 | Iterum Therapeutics International Limited | Combinations of beta-lactam compounds and probenecid and uses thereof |
US11554112B2 (en) | 2018-06-07 | 2023-01-17 | Herum Therapeutics International Limited | Combinations of β-lactam compounds and probenecid and uses thereof |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8227235B2 (en) * | 2008-12-10 | 2012-07-24 | Alpharma, Llc | Compositions and methods for controlling diseases in animals |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0306465A1 (en) * | 1987-08-31 | 1989-03-08 | Nicasystem Aktiebolag | Granular product (III) |
-
1998
- 1998-03-04 UA UA99116272A patent/UA59394C2/en unknown
- 1998-04-03 CA CA002291780A patent/CA2291780A1/en not_active Abandoned
- 1998-04-03 EA EA199900938A patent/EA002148B1/en not_active IP Right Cessation
- 1998-04-03 AP APAP/P/1999/001724A patent/AP9901724A0/en unknown
- 1998-04-03 EP EP98909680A patent/EP0998295A1/en not_active Withdrawn
- 1998-04-03 ID IDW991648A patent/ID26341A/en unknown
- 1998-04-03 JP JP54906699A patent/JP2002516616A/en not_active Ceased
- 1998-04-03 WO PCT/IB1998/000445 patent/WO1999049875A1/en not_active Application Discontinuation
- 1998-04-03 AU AU64156/98A patent/AU770024B2/en not_active Ceased
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0306465A1 (en) * | 1987-08-31 | 1989-03-08 | Nicasystem Aktiebolag | Granular product (III) |
Non-Patent Citations (1)
Title |
---|
PATENT ABSTRACTS OF JAPAN, Vol. 13, No. 286, 29 June 1989; & JP 1083025 A (FUJIO HAYASHI). * |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011033310A1 (en) * | 2009-09-17 | 2011-03-24 | William John Martin | Encapsulated intestinal flora extracted from feces for use in the treatment of gastrointestinal disorders |
WO2011086575A2 (en) * | 2010-01-13 | 2011-07-21 | Toyochem Laboratories | A pharmaceutical composition for treatment of respiratory tract infections |
WO2011086575A3 (en) * | 2010-01-13 | 2011-09-22 | Toyochem Laboratories | A pharmaceutical composition for treatment respiratory tract infections |
US11554112B2 (en) | 2018-06-07 | 2023-01-17 | Herum Therapeutics International Limited | Combinations of β-lactam compounds and probenecid and uses thereof |
WO2020164788A1 (en) * | 2019-02-13 | 2020-08-20 | Iterum Therapeutics International Limited | Combinations of beta-lactam compounds and probenecid and uses thereof |
US11478428B2 (en) | 2019-02-13 | 2022-10-25 | Iterum Therapeutics International Limited | Combinations of beta-lactam compounds and probenecid and uses thereof |
Also Published As
Publication number | Publication date |
---|---|
EP0998295A1 (en) | 2000-05-10 |
JP2002516616A (en) | 2002-06-04 |
AU6415698A (en) | 1999-10-18 |
ID26341A (en) | 2000-12-14 |
EA002148B1 (en) | 2001-12-24 |
AP9901724A0 (en) | 1999-12-31 |
CA2291780A1 (en) | 1999-10-07 |
EA199900938A1 (en) | 2000-08-28 |
AU770024B2 (en) | 2004-02-12 |
UA59394C2 (en) | 2003-09-15 |
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