DE69233130D1 - Kaubare zusammensetzung zur arzneimittelfreisetzung - Google Patents
Kaubare zusammensetzung zur arzneimittelfreisetzungInfo
- Publication number
- DE69233130D1 DE69233130D1 DE69233130T DE69233130T DE69233130D1 DE 69233130 D1 DE69233130 D1 DE 69233130D1 DE 69233130 T DE69233130 T DE 69233130T DE 69233130 T DE69233130 T DE 69233130T DE 69233130 D1 DE69233130 D1 DE 69233130D1
- Authority
- DE
- Germany
- Prior art keywords
- composition
- chewable
- release composition
- chewable medicinal
- medicinal release
- 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.)
- Expired - Fee Related
Links
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US70634391A | 1991-05-28 | 1991-05-28 | |
US706343 | 1991-05-28 | ||
PCT/US1992/004463 WO1992021328A1 (en) | 1991-05-28 | 1992-05-27 | Chewable drug-delivery composition |
Publications (2)
Publication Number | Publication Date |
---|---|
DE69233130D1 true DE69233130D1 (de) | 2003-08-21 |
DE69233130T2 DE69233130T2 (de) | 2005-06-02 |
Family
ID=24837153
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69233130T Expired - Fee Related DE69233130T2 (de) | 1991-05-28 | 1992-05-27 | Kaubare zusammensetzung zur arzneimittelfreisetzung |
Country Status (11)
Country | Link |
---|---|
US (1) | US5320848A (de) |
EP (1) | EP0587744B1 (de) |
JP (1) | JP2948317B2 (de) |
AT (1) | ATE245023T1 (de) |
AU (1) | AU653423B2 (de) |
CA (1) | CA2103443C (de) |
DE (1) | DE69233130T2 (de) |
DK (1) | DK0587744T3 (de) |
ES (1) | ES2202302T3 (de) |
IL (1) | IL102045A0 (de) |
WO (1) | WO1992021328A1 (de) |
Families Citing this family (69)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB9221414D0 (en) * | 1992-10-13 | 1992-11-25 | Glaxo Group Ltd | Pharmaceutical compositions |
DE69313865T2 (de) * | 1992-10-16 | 1998-02-12 | Glaxo Group Ltd | Geschmacksmaskierende zusammensetzungen von ranitidin |
GB9224855D0 (en) * | 1992-11-27 | 1993-01-13 | Smithkline Beecham Plc | Pharmaceutical compositions |
US5637313A (en) * | 1994-12-16 | 1997-06-10 | Watson Laboratories, Inc. | Chewable dosage forms |
US5807578A (en) * | 1995-11-22 | 1998-09-15 | Lab Pharmaceutical Research International Inc. | Fast-melt tablet and method of making same |
US5807577A (en) * | 1995-11-22 | 1998-09-15 | Lab Pharmaceutical Research International Inc. | Fast-melt tablet and method of making same |
JP3618355B2 (ja) * | 1995-12-26 | 2005-02-09 | オネスタ・ニュートリション・インコーポレーテッド | 食物繊維デリバリーシステム |
GB9702799D0 (en) * | 1997-02-12 | 1997-04-02 | Scherer Corp R P | Process for preparing solid pharmaceutical dosage forms |
US6242019B1 (en) * | 1997-08-14 | 2001-06-05 | Warner-Lambert Company | Taste modified hard confectionery compositions containing functional ingredients |
TW527195B (en) * | 1997-10-09 | 2003-04-11 | Ssp Co Ltd | Fast-soluble solid pharmaceutical combinations |
US5891476A (en) * | 1997-12-22 | 1999-04-06 | Reo; Joe P. | Tastemasked pharmaceutical system |
AU5904698A (en) * | 1997-12-29 | 1999-07-19 | Procter & Gamble Company, The | Tablet composition |
US6099865A (en) * | 1998-07-08 | 2000-08-08 | Fmc Corporation | Croscarmellose taste masking |
FR2785538B1 (fr) * | 1998-11-06 | 2004-04-09 | Prographarm Laboratoires | Comprime a delitement rapide perfectionne |
GB2344520A (en) * | 1998-12-08 | 2000-06-14 | Phares Pharm Res Nv | Pharmaceutical carriers comprising lipids and polymers |
US20030026835A1 (en) * | 1999-02-15 | 2003-02-06 | Sumitomo Pharmaceuticals Company Limited | Tablets disintegrating rapidly in the oral cavity |
WO2000054811A1 (fr) * | 1999-03-17 | 2000-09-21 | Daiichi Pharmaceutical Co., Ltd. | Compositions medicamenteuses |
TR200200562T2 (tr) | 1999-06-14 | 2002-05-21 | Cosmo S.P.A | Vücutta kontrollü şekilde salgılanabilen ve nahoş tadı önleyebilen ağızdan alınmaya mahsus farmasötik bileşimler |
US8895064B2 (en) | 1999-06-14 | 2014-11-25 | Cosmo Technologies Limited | Controlled release and taste masking oral pharmaceutical composition |
CA2380449A1 (en) * | 1999-08-17 | 2001-02-22 | Novartis Consumer Health S.A. | Rapidly dissolving dosage form and process for making same |
US6258381B1 (en) | 2000-02-11 | 2001-07-10 | Mcneil-Ppc, Inc. | Tablet and process for making the same |
US6277409B1 (en) * | 2000-02-11 | 2001-08-21 | Mcneil-Ppc, Inc. | Protective coating for tablet |
US20030149288A1 (en) * | 2000-04-18 | 2003-08-07 | Natural Asa | Conjugated linoleic acid powder |
US6375982B1 (en) | 2000-07-05 | 2002-04-23 | Capricorn Pharma, Inc. | Rapid-melt semi-solid compositions, methods of making same and method of using same |
AU2001279284A1 (en) * | 2000-07-05 | 2002-01-14 | Capricorn Pharma, Inc | Rapid-melt semi-solid compositions, methods of making same and methods of using same |
JP2002087965A (ja) * | 2000-09-14 | 2002-03-27 | Lion Corp | 口中崩壊性アスピリン含有錠剤 |
UA80393C2 (uk) * | 2000-12-07 | 2007-09-25 | Алтана Фарма Аг | Фармацевтична композиція, яка містить інгібітор фде 4, диспергований в матриці |
DK1341528T3 (da) * | 2000-12-07 | 2012-03-26 | Nycomed Gmbh | Hurtigtopløsende tablet omfattende en syrelabil aktiv bestanddel |
JP2004534812A (ja) | 2001-06-22 | 2004-11-18 | ファイザー・プロダクツ・インク | 薬物および中性ポリマーの分散物の医薬組成物 |
PT1411899E (pt) * | 2001-08-01 | 2009-04-24 | Novartis Ag | Composição de mascaramento de sabor |
US20040052852A1 (en) * | 2001-09-25 | 2004-03-18 | Michael Farber | Carbohydrate-based delivery system for creatine and other bioactive ingredients |
US20050019390A1 (en) * | 2001-10-26 | 2005-01-27 | John Kohnke | Dosage system and dosage vehicle therefor |
FR2834212B1 (fr) * | 2001-12-27 | 2004-07-09 | Besins Int Belgique | Utilisation d'une poudre a liberation immediate dans des compositions pharmaceutiques et nutraceutiques |
MY140561A (en) | 2002-02-20 | 2009-12-31 | Nycomed Gmbh | Dosage form containing pde 4 inhibitor as active ingredient |
AU2003209475A1 (en) * | 2002-03-07 | 2003-09-16 | Vectura Limited | Fast melt multiparticulate formulations for oral delivery |
US7067150B2 (en) | 2002-04-16 | 2006-06-27 | Scepter Holdings, Inc. | Delivery systems for functional ingredients |
WO2003097013A1 (en) * | 2002-05-16 | 2003-11-27 | Tecnofarma Corp. | Mono-coating for powdered pharmaceuticals |
AUPS244002A0 (en) * | 2002-05-20 | 2002-06-13 | John Kohnke Products Pty Ltd | Agent delivery system |
US20040037869A1 (en) * | 2002-08-16 | 2004-02-26 | Douglas Cleverly | Non-animal product containing veterinary formulations |
US20040151759A1 (en) * | 2002-08-16 | 2004-08-05 | Douglas Cleverly | Non-animal product containing veterinary formulations |
US20040109889A1 (en) * | 2002-12-04 | 2004-06-10 | Bunick Frank J. | Surface treatment composition for soft substrates |
DE602004023921D1 (de) | 2003-03-10 | 2009-12-17 | Nycomed Gmbh | Neues verfahren zur herstellung vonroflumilast |
US20080160086A1 (en) * | 2004-02-19 | 2008-07-03 | Scepter Holdings, Inc. | Delivery Systems For Calcium |
US8663694B2 (en) * | 2005-03-16 | 2014-03-04 | Takeda Gmbh | Taste masked dosage form containing roflumilast |
US8497258B2 (en) | 2005-11-12 | 2013-07-30 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
US7811604B1 (en) | 2005-11-14 | 2010-10-12 | Barr Laboratories, Inc. | Non-effervescent, orally disintegrating solid pharmaceutical dosage forms comprising clozapine and methods of making and using the same |
US20070128251A1 (en) * | 2005-12-07 | 2007-06-07 | Piedmont Pharmaceuticals, Inc. | Process for manufacturing chewable dosage forms for drug delivery and products thereof |
US7955632B2 (en) * | 2005-12-07 | 2011-06-07 | Bayer B.V. | Process for manufacturing chewable dosage forms for drug delivery and products thereof |
US7767248B2 (en) | 2007-02-02 | 2010-08-03 | Overly Iii Harry J | Soft chew confectionary with high fiber and sugar content and method for making same |
US20090060983A1 (en) * | 2007-08-30 | 2009-03-05 | Bunick Frank J | Method And Composition For Making An Orally Disintegrating Dosage Form |
US9078824B2 (en) | 2007-09-24 | 2015-07-14 | The Procter & Gamble Company | Composition and method of stabilized sensitive ingredient |
US20090110716A1 (en) | 2007-10-31 | 2009-04-30 | Frank Bunick | Orally disintegrative dosage form |
US20110097401A1 (en) | 2009-06-12 | 2011-04-28 | Meritage Pharma, Inc. | Methods for treating gastrointestinal disorders |
US20110070286A1 (en) * | 2009-09-24 | 2011-03-24 | Andreas Hugerth | Process for the manufacture of nicotine-comprising chewing gum and nicotine-comprising chewing gum manufactured according to said process |
US8313768B2 (en) | 2009-09-24 | 2012-11-20 | Mcneil-Ppc, Inc. | Manufacture of tablet having immediate release region and sustained release region |
US8858210B2 (en) | 2009-09-24 | 2014-10-14 | Mcneil-Ppc, Inc. | Manufacture of variable density dosage forms utilizing radiofrequency energy |
US8784781B2 (en) * | 2009-09-24 | 2014-07-22 | Mcneil-Ppc, Inc. | Manufacture of chewing gum product with radiofrequency |
WO2011087705A2 (en) * | 2009-12-22 | 2011-07-21 | Fmc Corporation | Fine particle croscarmellose and uses thereof |
US10154964B2 (en) | 2011-09-07 | 2018-12-18 | Cosmo Technologies Limited | Controlled release and taste masking oral pharmaceutical composition |
JP5828280B2 (ja) * | 2011-12-28 | 2015-12-02 | ライオン株式会社 | 錠剤及びその製造方法 |
US9511028B2 (en) | 2012-05-01 | 2016-12-06 | Johnson & Johnson Consumer Inc. | Orally disintegrating tablet |
US9445971B2 (en) | 2012-05-01 | 2016-09-20 | Johnson & Johnson Consumer Inc. | Method of manufacturing solid dosage form |
US9233491B2 (en) | 2012-05-01 | 2016-01-12 | Johnson & Johnson Consumer Inc. | Machine for production of solid dosage forms |
ES2750323T3 (es) | 2014-01-10 | 2020-03-25 | Johnson & Johnson Consumer Inc | Método para la fabricación de un comprimido mediante radiofrecuencia y partículas recubiertas con pérdida |
CN108712900A (zh) * | 2015-12-19 | 2018-10-26 | 第时间美国泛型药物有限公司 | 软咀嚼片剂药物制剂 |
US10493026B2 (en) | 2017-03-20 | 2019-12-03 | Johnson & Johnson Consumer Inc. | Process for making tablet using radiofrequency and lossy coated particles |
GB2585413B (en) | 2019-02-22 | 2023-04-26 | Catalent Uk Swindon Zydis Ltd | Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products |
EP3927313A1 (de) | 2019-02-22 | 2021-12-29 | Catalent U.K. Swindon Zydis Limited | Konservierende funktionalisierte api-partikel, die durch lösungsmittelfreie mischprozesse in wässriger suspension hergestellt werden |
EP3927312B1 (de) * | 2019-02-22 | 2023-09-13 | Catalent U.K. Swindon Zydis Limited | Minimierung der agglomeration, belüftung und konservierung der beschichtung von pharmazeutischen zusammensetzungen mit ibuprofen |
Family Cites Families (31)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2887437A (en) * | 1956-08-22 | 1959-05-19 | Pfizer & Co C | Palatable vitamin tablet containing an amino acid |
US3108046A (en) * | 1960-11-25 | 1963-10-22 | Smith Kline French Lab | Method of preparing high dosage sustained release tablet and product of this method |
US3138525A (en) * | 1961-06-16 | 1964-06-23 | Hoffmann La Roche | Castor wax-amprotropine-resin compositions |
US3279998A (en) * | 1962-06-22 | 1966-10-18 | Smith Kline French Lab | Method of preparing sustained release tablets |
US3279988A (en) * | 1965-03-17 | 1966-10-18 | Lilly Co Eli | Process of treating helminthiasis with oxadiazole derivatives |
GB1323161A (en) * | 1970-02-16 | 1973-07-11 | Wyeth John & Brother Ltd | Penicillin composition |
DE2706660A1 (de) * | 1977-02-17 | 1978-08-24 | Merck Patent Gmbh | Ascorbinsaeure enthaltende granulate und verfahren zu ihrer herstellung |
US4206209A (en) * | 1978-11-02 | 1980-06-03 | Kracauer Paul | Sublingual aspirin tablet |
JPS6029682B2 (ja) * | 1980-07-11 | 1985-07-12 | 山之内製薬株式会社 | 苦味のない製剤用組成物およびその製造法 |
JPS57145807A (en) * | 1981-03-06 | 1982-09-09 | Kowa Yakuhin Kogyo Kk | Preparation of ibuprofen pharmaceutical |
US4375468A (en) * | 1981-07-13 | 1983-03-01 | Verex Laboratories, Inc. | Constant order release aspirin composition and method of treating arthritis |
FR2515035A1 (fr) * | 1981-10-26 | 1983-04-29 | Rhone Poulenc Sante | Nouvelle forme galenique solide pour administration par voie orale et son procede de fabrication |
US4517179A (en) * | 1983-04-29 | 1985-05-14 | Pennwalt Corporation | Rapid dissolving, uniform drug compositions and their preparation |
US4882167A (en) * | 1983-05-31 | 1989-11-21 | Jang Choong Gook | Dry direct compression compositions for controlled release dosage forms |
JPS6124516A (ja) * | 1984-07-12 | 1986-02-03 | Fujisawa Pharmaceut Co Ltd | 持続性錠剤 |
US4894233A (en) * | 1984-10-05 | 1990-01-16 | Sharma Shri C | Novel drug delivery system for decongestants |
IE58110B1 (en) * | 1984-10-30 | 1993-07-14 | Elan Corp Plc | Controlled release powder and process for its preparation |
US4755387A (en) * | 1985-03-21 | 1988-07-05 | The Procter & Gamble Company | Therapeutic particles |
JPS62126122A (ja) * | 1985-11-27 | 1987-06-08 | Showa Shinyaku Kk | 表面コ−テイングされたイブプロフエン顆粒の製法 |
US4882152A (en) * | 1985-12-20 | 1989-11-21 | Yang Robert K | Confectionery delivery system for laxatives, vitamins and antacids |
GB2186485B (en) * | 1986-02-13 | 1988-09-07 | Ethical Pharma Ltd | Slow release formulation |
GB8623557D0 (en) * | 1986-10-01 | 1986-11-05 | Boots Co Plc | Therapeutic agents |
EP0275468B1 (de) * | 1986-12-20 | 1991-02-06 | Roche Diagnostics GmbH | Clodronat-haltige Arzneimittel und Verfahren zur Herstellung derselben |
US4837255A (en) * | 1987-03-10 | 1989-06-06 | Ciba-Geigy Corporation | Palatable hypocholesterolaemic gel formulation containing a pharmaceutically acceptable non-digestible anion exchange resin |
KR960011236B1 (ko) * | 1987-05-08 | 1996-08-21 | 스미스 클라인 앤드 프렌취 라보라토리스 리미티드 | 제약학적 조성물 및 고체 제형 |
NL193682C (nl) * | 1987-05-14 | 2000-07-04 | Glaxo Group Ltd | Beklede cefuroximaxetilsamenstelling. |
US4835186A (en) * | 1987-06-15 | 1989-05-30 | American Home Products Corporation | Spray dried ibuprofen |
US4835187A (en) * | 1987-06-15 | 1989-05-30 | American Home Products Corporation | Spray dried ibuprofen |
US4835188A (en) * | 1987-12-08 | 1989-05-30 | American Home Products Corporation | Spray dried ibuprofen |
GB8730011D0 (en) * | 1987-12-23 | 1988-02-03 | Smithkline Dauelsberg | Pharmaceutical compositions |
US4916161A (en) * | 1988-10-25 | 1990-04-10 | Bristol-Myers Squibb | Taste-masking pharmaceutical agents |
-
1992
- 1992-05-27 DE DE69233130T patent/DE69233130T2/de not_active Expired - Fee Related
- 1992-05-27 US US07/889,179 patent/US5320848A/en not_active Expired - Lifetime
- 1992-05-27 EP EP92913138A patent/EP0587744B1/de not_active Expired - Lifetime
- 1992-05-27 ES ES92913138T patent/ES2202302T3/es not_active Expired - Lifetime
- 1992-05-27 AT AT92913138T patent/ATE245023T1/de not_active IP Right Cessation
- 1992-05-27 DK DK92913138T patent/DK0587744T3/da active
- 1992-05-27 AU AU21467/92A patent/AU653423B2/en not_active Ceased
- 1992-05-27 WO PCT/US1992/004463 patent/WO1992021328A1/en active IP Right Grant
- 1992-05-27 JP JP5500545A patent/JP2948317B2/ja not_active Expired - Lifetime
- 1992-05-27 CA CA002103443A patent/CA2103443C/en not_active Expired - Lifetime
- 1992-05-28 IL IL102045A patent/IL102045A0/xx unknown
Also Published As
Publication number | Publication date |
---|---|
CA2103443C (en) | 1998-12-22 |
IL102045A0 (en) | 1992-12-30 |
ES2202302T3 (es) | 2004-04-01 |
JP2948317B2 (ja) | 1999-09-13 |
JPH06511478A (ja) | 1994-12-22 |
AU2146792A (en) | 1993-01-08 |
EP0587744B1 (de) | 2003-07-16 |
DE69233130T2 (de) | 2005-06-02 |
WO1992021328A1 (en) | 1992-12-10 |
EP0587744A4 (en) | 1994-05-25 |
AU653423B2 (en) | 1994-09-29 |
DK0587744T3 (da) | 2003-10-20 |
EP0587744A1 (de) | 1994-03-23 |
ATE245023T1 (de) | 2003-08-15 |
US5320848A (en) | 1994-06-14 |
CA2103443A1 (en) | 1992-11-29 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
DE69233130D1 (de) | Kaubare zusammensetzung zur arzneimittelfreisetzung | |
BRPI0015567B8 (pt) | composto, composição farmacêutica, forma de unidade de dosagem, uso da composição farmacêutica e método para preparar uma composição farmacêutica | |
DK1348429T3 (da) | Smelteekstruderede opioidformuleringer, der kan administreres oralt | |
ATE232090T1 (de) | Orale pharmazeutische zusammensetzungen die pantoprazol mit verzögerter freisetzung und antimikrobielle mittel enthalten | |
CO5170471A1 (es) | Tabletas de liberacion modificada que incluyen amoxilina y clavulanato de potasio | |
DE69520882T2 (de) | Arzneizubereitung enthaltend amoxycillin und kaliumclavunalat | |
BR0003158A (pt) | Formulação de dosagem oral de derretimentoinstantâneo | |
BR0014383A (pt) | Composições de liberação controlada compreendendo nimesulida | |
BR0107869A (pt) | Composições farmacêuticas eletrogiradas | |
BRPI0406996A (pt) | Formas de dosagem sólida via transmucosa oral sem açúcar e sua utilização | |
HUP0101237A1 (hu) | Elnyújtott kioldódású gyógyszerkészítmények | |
EP0966966A3 (de) | Nefazodon enthaltende Dosierungsform | |
BRPI0408655A (pt) | formulações compreendendo um agente ativo e cacau em pó e a sua utilização | |
RS50768B (sr) | Režim doziranja i farmaceutska formulacija za urgentnu zaštitu | |
NZ219300A (en) | Veterinary composition for release of actives into the rumen | |
CA2135179A1 (en) | Pharmaceutical Compositions of Alkylsulphonamides 5HT1 Agonists for Rectal Administration | |
PT927031E (pt) | Composicao farmaceutica que contem nimesulide para administracao por via oral | |
IT1317871B1 (it) | Sistemi terapeutici per forme farmaceutiche orali di principi attiviaventi sfavorevoli caratteristiche organolettiche. |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
8364 | No opposition during term of opposition | ||
8328 | Change in the person/name/address of the agent |
Representative=s name: BOEHMERT & BOEHMERT, 28209 BREMEN |
|
8339 | Ceased/non-payment of the annual fee |