EP1406601A2 - Pharmazeutische zusammensetzungen zur oral verabreichung, enthaltend eine kombination von metformin und glicazid, ein sulfonylharnstoff - Google Patents

Pharmazeutische zusammensetzungen zur oral verabreichung, enthaltend eine kombination von metformin und glicazid, ein sulfonylharnstoff

Info

Publication number
EP1406601A2
EP1406601A2 EP02760233A EP02760233A EP1406601A2 EP 1406601 A2 EP1406601 A2 EP 1406601A2 EP 02760233 A EP02760233 A EP 02760233A EP 02760233 A EP02760233 A EP 02760233A EP 1406601 A2 EP1406601 A2 EP 1406601A2
Authority
EP
European Patent Office
Prior art keywords
metformin
glyclazide
pharmaceutical compositions
day
treatment
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.)
Withdrawn
Application number
EP02760233A
Other languages
English (en)
French (fr)
Inventor
Edoardo L.Molteni & C. Dei Fratelli MANNUCCI
Roberto L. Molteni & C. Dei Fratelli ANGELI
Marco L. Molteni & C. Dei Fratelli BONIFACIO
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.)
L Molteni and C dei Fratelli Alitti Societa di Esercizio SpA
Molteni and C SpA
Original Assignee
L Molteni and C dei Fratelli Alitti Societa di Esercizio SpA
Molteni and C SpA
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 L Molteni and C dei Fratelli Alitti Societa di Esercizio SpA, Molteni and C SpA filed Critical L Molteni and C dei Fratelli Alitti Societa di Esercizio SpA
Publication of EP1406601A2 publication Critical patent/EP1406601A2/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • compositions for oral use containing, in combination, metformin and glyclazide
  • the present invention relates to pharmaceutical compositions for oral use, containing, in combination, metformin and glyclazide in given quantities.
  • diabetes type II is a frequent metabolic illness, characterised by insulin-resistance and by deficit of insulin secretion, with consequent hyperglycaemia.
  • Accurate control of glycaemia, maintaining fasting values, as well as values after meals, close to normality is important for the long-term prevention of the chronic complications of diabetes.
  • the drugs that are commonly used in the treatment of hyperglycaemia in patients with diabetes type II can be divided into three major categories: a) drugs that stimulate insulin secretion, such as sulphonylureas and meglitinides.
  • insulin can be administered by subcutaneous route; b) drugs that increase insulin sensitivity (metformin or thiazolidinediones); and c) drugs that slow down intestinal absorption of carbohydrates (acarbose).
  • a second drug is added, reserving the treatment with insulin to the cases not adequately controlled with a combination of two oral drugs.
  • glycaemia For the control of glycaemia various drugs belonging to the classes indicated above have been used, such as metformin, glybenclamide, chlorpropamide, fenformin and glyclazide.
  • compositions containing two of the aforesaid active principles in combination there are moreover known compositions containing two of the aforesaid active principles in combination.
  • Galeone et al. Minerva Endocrinol, Vol. 23, no 3, September 1998 pages 71-75 and Guillausseau P.J. Diabetic Medicine Vol. 14, n° 9 September 1997 pages 798-802 describe the combined use of metformin and glyclazide in the treatment of type 2 diabetes.
  • both drugs were used at sub-maximal doses (1.5 g/day for metformin, 120 mg/day for glyclazide). Such low doses of the two drugs could be insufficient to obtain a proper reduction of cardiovascular risk in patient with type 2 diabetes.
  • compositions for oral use containing as active principles metformin and glyclazide in quantities comprised between 500 — 1000 mg for metformin and between 20 - 80 for glyclazide allow to overcome the above said problems.
  • compositions according to the invention can contribute to the prevention of chronic, micro- and macro-vascular, complications of diabetes type II.
  • compositions are the ones containing 850, 850, 500, 1000, 1000 mg of metformin together with respectively 40, 80, 80, 40 and 80 mg of glyclazide.
  • compositions according to the invention containing
  • compositions according to the present invention can be prepared using the techniques known in pharmacopoeia for the preparation of formulations for oral use, for example: tablets, capsules, pills, chewable tablets, preparations for sublingual absorption etc.
  • immediate-release tablets are particularly preferred.
  • excipients normally used are the ones used as binders (e.g., pre-gelatinized starch), diluents (e.g., microcrystalline cellulose), glidants (e.g., colloidal silica), wetting agents (e.g., Tween 80), disgregating agents (e.g., sodium amidoglycolate), lubricants (e.g., magnesium stearate), and film-coating agents
  • binders e.g., pre-gelatinized starch
  • diluents e.g., microcrystalline cellulose
  • glidants e.g., colloidal silica
  • wetting agents e.g., Tween 80
  • disgregating agents e.g., sodium amidoglycolate
  • lubricants e.g., magnesium stearate
  • film-coating agents e.g., film-coating agents
  • formulations according to the invention in the form of high-disgregation tablets which enable immediate release of the active principles.
  • Particularly preferred tablets of this type are 950-mg tablets which contain (in addition to two active principles in the amounts indicated above) the following additives: Microcrystalline cellulose: as required for 950 mg
  • Pre-gelatinized starch 60 mg
  • the size of an industrial lot is approximately 350 000 tablets corresponding to 322 kg.
  • compositions according to the invention can be used in the treatment of diabetes mellitus type II in patients who are not adequately controlled with metformin alone or with a sulphonylurea agent alone.
  • patients not adequately controlled with metformin alone could pass to metformin 850 mg + glyclazide 40 mg three times a day, which guarantees an effective dose of metformin with the addition of a small dose of glyclazide for stimulating insulin secretion.
  • metformin 850 mg + glyclazide 80 mg three times a day and possibly to metformin 1000 mg + glyclazide 80 mg three times a day.
  • Patients not adequately controlled with a sulphonylurea agent alone could pass to glyclazide 80 mg + metformin 850 mg three times a day, so as to maintain a sufficiently high dose of sulphonylurea and add thereto the insulin- sensitising action of metformin.

Landscapes

  • Health & Medical Sciences (AREA)
  • Diabetes (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP02760233A 2001-07-09 2002-07-09 Pharmazeutische zusammensetzungen zur oral verabreichung, enthaltend eine kombination von metformin und glicazid, ein sulfonylharnstoff Withdrawn EP1406601A2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITFI20010126 2001-07-09
IT2001FI000126A ITFI20010126A1 (it) 2001-07-09 2001-07-09 Composizioni farmaceutiche per uso orale,contenenti,in combinazione,metformina e gliclazide
PCT/EP2002/007633 WO2003006004A2 (en) 2001-07-09 2002-07-09 Pharmaceutical compositions for oral use, containing, in combination, metformin and glicazide, a sulphonyl urea

Publications (1)

Publication Number Publication Date
EP1406601A2 true EP1406601A2 (de) 2004-04-14

Family

ID=11442232

Family Applications (2)

Application Number Title Priority Date Filing Date
EP01122360A Withdrawn EP1275384A1 (de) 2001-07-09 2001-09-19 Pharmazeutische Zusammensetzungen zur oralen Verwendung enthaltend,in Kombination, Metformine und Glyclazide
EP02760233A Withdrawn EP1406601A2 (de) 2001-07-09 2002-07-09 Pharmazeutische zusammensetzungen zur oral verabreichung, enthaltend eine kombination von metformin und glicazid, ein sulfonylharnstoff

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP01122360A Withdrawn EP1275384A1 (de) 2001-07-09 2001-09-19 Pharmazeutische Zusammensetzungen zur oralen Verwendung enthaltend,in Kombination, Metformine und Glyclazide

Country Status (8)

Country Link
EP (2) EP1275384A1 (de)
CN (1) CN1638750A (de)
AU (1) AU2002325875A1 (de)
CA (1) CA2453308A1 (de)
IT (1) ITFI20010126A1 (de)
PL (1) PL373393A1 (de)
RU (1) RU2004103531A (de)
WO (1) WO2003006004A2 (de)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITFI20010126A1 (it) * 2001-07-09 2003-01-09 Molteni & C Composizioni farmaceutiche per uso orale,contenenti,in combinazione,metformina e gliclazide
FR2896157B1 (fr) 2006-01-13 2008-09-12 Merck Sante Soc Par Actions Si Combinaison de derives de triazine et d'agents de stimulation de secretion d'insuline.
DE102007009208B4 (de) * 2007-02-26 2010-01-28 Fresenius Medical Care Deutschland Gmbh Hohlfaser, Hohlfaserbündel, Filter sowie Verfahren zur Herstellung einer Hohlfaser oder eines Hohlfaserbündels
CN103468006B (zh) * 2013-09-11 2014-07-02 广州市市政工程维修处 一种废旧沥青再生路面用材料及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9715295D0 (en) * 1997-07-18 1997-09-24 Smithkline Beecham Plc Novel method of treatment
ITFI20010126A1 (it) * 2001-07-09 2003-01-09 Molteni & C Composizioni farmaceutiche per uso orale,contenenti,in combinazione,metformina e gliclazide

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO03006004A2 *

Also Published As

Publication number Publication date
AU2002325875A1 (en) 2003-01-29
WO2003006004A3 (en) 2003-04-17
CA2453308A1 (en) 2003-01-23
CN1638750A (zh) 2005-07-13
ITFI20010126A1 (it) 2003-01-09
WO2003006004A2 (en) 2003-01-23
PL373393A1 (en) 2005-08-22
EP1275384A1 (de) 2003-01-15
RU2004103531A (ru) 2005-04-20

Similar Documents

Publication Publication Date Title
RU2226396C2 (ru) Твердая дозированная лекарственная форма для орального применения, содержащая комбинацию метформина и глибенкламида
US7507768B2 (en) Antidiabetic formulation and method
EP1097710B1 (de) Kombinationspräparat zur Behandlung von nicht-Insulinabhängige Diabetes Mellitus (NIDDM)
TWI241185B (en) Antidiabetic formulation
Derosa et al. Telmisartan and irbesartan therapy in type 2 diabetic patients treated with rosiglitazone: effects on insulin-resistance, leptin and tumor necrosis factor-α
TWI280125B (en) Pharmaceutical compositions for treating type 2 diabetes in drug naive human patients
Vijayakumar et al. Safety, efficacy, and bioavailability of fixed-dose combinations in type 2 diabetes mellitus: a systematic updated review
US20100074950A1 (en) Anti-diabetic combinations
EA023243B1 (ru) Фармацевтическая композиция, включающая линаглиптин и необязательно ингибитор sglt2, и ее применение
KR20210005843A (ko) Glp1r 작용제의 치료적 용도
Gökçay Canpolat et al. Glucose lowering treatment modalities of type 2 diabetes mellitus
CN110339176A (zh) 包含吉格列汀和二甲双胍的组合药物及其制备方法
WO2021086292A1 (en) Bilayer tablet formulations comprising dapagliflozin and metformin
CN108430467A (zh) 治疗高血糖的方法
WO2003006004A2 (en) Pharmaceutical compositions for oral use, containing, in combination, metformin and glicazide, a sulphonyl urea
KR100709528B1 (ko) 혈당콘트롤용 의약조성물
Kadhe et al. Advances in drug delivery of oral hypoglycemic agents
WO2019162800A1 (en) Pharmacutical composition comprising remogliflozin and antidiabetic agent
US20100016333A1 (en) Once-a-day (RNA-Polymerase Inhibiting or phenazine) - dihydropteroate synthase inhibiting - dihydrofolate reductase inhibiting antibiotic pharmaceutical product, formulation thereof, and use thereof in treating infection caused by Methicillin-Resistant Staphylococcus aureus
WO2020155098A1 (zh) 一种用于治疗糖尿病的药物组合物及其制备方法和用途
WO2004069229A1 (en) Dual release anti-diabetic drugs and process of production thereof
KR20060006469A (ko) 메트포르민 및 글리메피리드 복합제제를 포함하는 경구용당뇨병치료제 조성물 및 그의 제조방법
WO2004091587A1 (en) Multiple release anti-diabetic drugs and process of production thereof

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20040209

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR IE IT LI LU MC NL PT SE SK TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

17Q First examination report despatched

Effective date: 20090518

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20090929