Patent application EP17150114A (EP), filed 2017-01-03
Publication number: EP3202393A1
Title: INTRADERMAL ADMINISTRATION OF IMMUNOGLOBULIN G PREPARATION
Abstract: A method for administration of an IgG preparation by an intradermal (ID) route to a subject in need thereof includes loading with a volume of the IgG preparation an ID delivery device including needles, applying the device to a skin delivery site, using the device to allow dermal penetration of the needles, delivering the volume of the IgG preparation at the skin delivery site, and removing the injection delivery device. Compositions of an IgG preparation are for use in the treatment of a disease in a subject in need thereof by the above method. The disease can be an immunodeficiency.
IPC codes: A61K  39/    00            A I
A61K   9/    00            A I
C07K  16/    00            A I
Claims: number: 1
text: Composition comprising IgG for use in the treatment of an immunodeficiency in a subject in need thereof by an intradermal (ID) route using a removable ID device comprising needles.
number: 2
text: Composition for use according to claim 1, wherein the IgG composition has an IgG concentration of 15% to 30% (w/v).
number: 3
text: Composition for use according to claim 1, wherein the IgG composition has an IgG concentration of 30% (w/v) or higher.
number: 4
text: Composition for use according to claim 1, wherein a pH of the IgG composition is from 4.5 to 8.0.
number: 5
text: Composition for use according to claim 4, wherein the pH of the IgG composition is 6.5.
number: 6
text: Composition for use according to claim 1, wherein the volume of the IgG composition is up to 10 mL per skin delivery site.
number: 7
text: Composition for use according to claim 6, wherein the volume of the IgG composition is between 2 mL and 8 mL per skin delivery site.
number: 8
text: Composition for use according to claim 6, wherein the volume of the IgG composition is between 4 mL and 6 mL per skin delivery site.
number: 9
text: Composition for use according to claim 1, wherein the IgG composition comprises one or more additional plasma proteins.
number: 10
text: Composition for use according to claim 1, wherein the subject is a pediatric patient.
number: 11
text: Composition for use according to claim 1, wherein the subject is a non-pediatric patient.
number: 12
text: Composition comprising IgG for the treatment of a disease in a subject in need thereof.
number: 13
text: Composition, according to claim 12, wherein the concentration of IgG in the IgG composition is 15% to 30% (w/v).
number: 14
text: Composition, according to claim 13, wherein the concentration of IgG in the IgG composition is 30% (w/v) or higher.
number: 15
text: Composition, according to claim 12, wherein the composition has a pH of 4.5 and 8.0.
number: 16
text: Composition according to claim 15, wherein the pH is 6.5.
number: 17
text: Composition according to claim 12, wherein the subject is a pediatric patient.
number: 18
text: Composition according to claim 12, wherein the subject is a non-pediatric patient.
number: 19
text: Composition according to claim 12, wherein the disease is an immunodeficiency.
number: 20
text: Composition according to claim 19, wherein the immunodeficiency is one of a primary immunodeficiency, a secondary immunodeficiency or an acquired immunodeficiency.
number: 21
text: Composition according to claim 12, wherein the IgG composition comprises an entire IgG molecule, a therapeutically effective fragment of IgG or a combination thereof.
number: 22
text: Composition according to claim 12, wherein the IgG composition comprises one or more additional plasma proteins.
Office action: search_report, dated 2017-08-09
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: - BURTON S.A ET AL., PHARMACEUTICAL RESEARCH, vol. 28, no. 1, 2011, pages 31 - 40
ref_type: npl
severity: background
ref_id: WO2005086773A2
ref_type: patent
severity: background
ref_id: [XDI]     - SCOTT A BURTON ET AL: "Rapid Intradermal Delivery of Liquid Formulations Using a Hollow Microstructured Array", PHARMACEUTICAL RESEARCH, KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NL, vol. 28, no. 1, 26 June 2010 (2010-06-26), pages 31 - 40, XP019869149, ISSN: 1573-904X, DOI: 10.1007/S11095-010-0177-8
ref_type: npl
severity: background
ref_id: - KORKMAZ EMRULLAH ET AL: "Therapeutic intradermal delivery of tumor necrosis factor-alpha antibodies using tip-loaded dissolvable microneedle arrays", ACTA BIOMATERIALIA, vol. 24, 18 June 2016 (2016-06-18), pages 96 - 105, XP029868110, ISSN: 1742-7061, DOI: 10.1016/J.ACTBIO.2015.05.036
ref_type: npl
severity: background
ref_id: - MÖNKÄRE JUHA ET AL: "IgG-loaded hyaluronan-based dissolving microneedles for intradermal protein delivery", JOURNAL OF CONTROLLED RELEASE, vol. 218, 5 October 2015 (2015-10-05), pages 53 - 62, XP029292440, ISSN: 0168-3659, DOI: 10.1016/J.JCONREL.2015.10.002
ref_type: npl
severity: background
ref_id: WO2005086773
ref_type: patent
severity: novelty_destroying
ref_id: - SCOTT A BURTON ET AL, "Rapid Intradermal Delivery of Liquid Formulations Using a Hollow Microstructured Array", PHARMACEUTICAL RESEARCH, KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NL, (20100626), vol. 28, no. 1, doi:10.1007/S11095-010-0177-8, ISSN 1573-904X, pages 31 - 40, XP019869149 [XD] 12 * See page 34, "Equine tetanus Anti-Toxin (ETAT)" and page 37, "Pharmacokinetics - In Vivo ETAT Delivery";; figure 1 * [I] 2-11,13-22
ref_type: npl
severity: novelty_destroying
ref_id: - KORKMAZ EMRULLAH ET AL, "Therapeutic intradermal delivery of tumor necrosis factor-alpha antibodies using tip-loaded dissolvable microneedle arrays", ACTA BIOMATERIALIA, (20160618), vol. 24, doi:10.1016/J.ACTBIO.2015.05.036, ISSN 1742-7061, pages 96 - 105, XP029868110 [AP] 1-22
ref_type: npl
severity: background
ref_id: - MÖNKÄRE JUHA ET AL, "IgG-loaded hyaluronan-based dissolving microneedles for intradermal protein delivery", JOURNAL OF CONTROLLED RELEASE, (20151005), vol. 218, doi:10.1016/J.JCONREL.2015.10.002, ISSN 0168-3659, pages 53 - 62, XP029292440 [A] 1-22
ref_type: npl
severity: background
Final disposition: pending (2017-08-09)