europaisches Patentamt European Patent Office © Publication number: 0 153 104 Office europeen des brevets A3

Q2) EUROPEAN PATENT APPLICATION

@ Application number: 85300844.9 @ Int. CI.4: A 61 K 9/52 A 61 K 9/54 (22)^ Date of filing: 08.02.85

® Priority: 10.02.84 DK 621/84 @ Applicant: A/S Alfred Benzon Halmtorvet 29 ^ DK-1700 Copenhagen V(DK) Date of publication of application : 28.08.85 Bulletin 85/35 @ Inventor: Kjornaes.Kim Trekronergade 25 ^88) Date of deferred publication of search report: 18.12.85 DK-2500 Valby(DK)

© Designated Contracting States: @ Inventor: Linnemann, Jorgen BE CH DE FR GB LI NL SE Alkmaar AII640 DK-2791 Dragor(DK) © Representative: Walls, Alan James Windy Ridge 2, Lywood Close Tadworth Surrey KT20 5SSIGB)

54) Diffusion coated multiple-units dosage form. 111 an orai pnarmaceuiicai contronea release multiple- units formulation, individual units containing an active substance are coated with a substantially water-insoluble, but water-diffusible controlled release coating which in- cludes 1 ) an inner film layer comprising a homogeneous combina- tion of a water-dispersible film-forming agent and a polymeric substance which imparts compressibility to the coating, and 2) optionally an outer film layer comprising a film-forming agent which prevents adhesion between the units at elevated temperatures and imparts flowability to the JO units. X The coating possesses a sufficient plastic deformability to result in no significant changes in the release characteris- J tics of compressed coated units relative to non-compressed 3 coated units.

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EP 85 30 0844

UUUUMfcN I S CONSIDERED TO BE RELEVANT unauuii ui uwuimni wun inuicauon, wnere appropriate, He levant CLASSIFICATION OF THE of relevant passages to claim APPLICATION (Int CM )

A 61 K 9/52 lits-A-^ At I ( BOEHRINGER 2-16, A 61 K 9/54 INGELHEIM) 19 * Page 1, lines 65-95, 107-109, 124-129; page 1, line 127 - page 2, line 10; page 2, lines 48-60; claims *

A, I Cjf-A-U UiJii U/5 ( CIBA-GEIGY) 1-20 * Page 1, paragraph 3; pages 2-4; example 1; claims *

A rYU-A-8 1UU UU4 (KEY 1-5,13 PHARMACEUT I CALS INC. ) ,14,17 -20 * Page 2, last line - page 3, line 9; examples 1,2; claims *

TECHNICAL FIELDS A EP-A-0 077 956 (TANABE SEIYAKTJ) 1-8,131 SEARCHED (Int. CM) -20 f * Page 4, line 4 - page 6, line 16; tables 3,4; claims * A 61 K 9/00

prsseni searcn repon nas Deen arawn up tor ail Claims jate ot completion oi me searcn Examiner rHE HAGUE 02-08-1985 1ERTE M.J.

0 I CATEGORY OF CITED DOCUMENTS i : theory or principle underlying the invention 3 E : earlier patent document, but published on, or particularly relevant if taken atone after the filing date particularly relevant if combined with another 3 : document cited in the application document of the same category : document cited for other reasons technological background . f>on-written disclosure 1 : member of the same patent family, corresponding ntermediate document document 0153104 European Patent Application number J) EUROPEAN SEARCH REPORT Office EP 85 30 0844

DOCUMENTS CONSIDERED TO BE RELEVANT Page 2 imitation or oocumem wun inaication. wnere appropriate, Relevant CLASSIFICATION OF THE oaiegory of relevant passages to claim APPLICATION (Int CM)

A, X CHEMICAL ABSTRACTS , vol. 93, no. 1-5,9- 20, November 1980, page 357, no. 11 191993d, Columbus, Ohio, US; M. D0NBR0W et al. : "Zero order drug delivery from double- layered porous films: release rate profiles from ethyl cellulose, hydroxypropyl cellulose, and polyethylene glycol mixtures", & J. PHARM. PHARMACOL. 1980, 32(7), 463-70 * Whole abstract *

fcR-A-2 237 620 (BYK GULDEN 1-20 LOMBERG) * Page 4, lines 3-7; page 10, line 37 - page 11, line 36; page 13, lines 13-30; example 1; claims * TECHNICAL FIELDS SEARCHED (Int CM)

i ne present searcn report nas oeen arawn up lor all claims riaca 01 searcn lww ot comptation ot the search Examiner TEE HAGUE 02-08-1985 5ERTE M.J.

CATEGORY Or CITED DOCLIMENTS r : theory or principle underlying the invention 3 1 E : earlier patent document, but published on, or K : particularly relevant if taken alone after the filing date Y : particularly relevant if combined with another 0 : document cited in the application document of the same category L : document cited for other reasons * . technological background D : non-written disclosure member of the same patent family, corresponding P : intermediate document document