U.S. patent application number 14/944778 was filed with the patent office on 2016-05-26 for assembly for use in a drug delivery device.
The applicant listed for this patent is SANOFI-AVENTIS DEUTSCHLAND GMBH. Invention is credited to Nils BASSO, Thomas NAGEL, Rene RICHTER, Jens Schirmer, Robert WITT.
Application Number | 20160144116 14/944778 |
Document ID | / |
Family ID | 41434755 |
Filed Date | 2016-05-26 |
United States Patent
Application |
20160144116 |
Kind Code |
A1 |
BASSO; Nils ; et
al. |
May 26, 2016 |
ASSEMBLY FOR USE IN A DRUG DELIVERY DEVICE
Abstract
The present invention relates to an assembly for a drug delivery
device comprising a dispensing container and a reservoir container
for holding a fluid medicinal product, wherein the dispensing
container and the reservoir container are connected to one another
and are in fluid communication, and wherein the dispensing
container is squeezable for dispensing a dose of the fluid
medicinal product from the dispensing container, the dispensing
container being refillable with the fluid medicinal product from
the reservoir container.
Inventors: |
BASSO; Nils; (Frankfurt am
Main, DE) ; NAGEL; Thomas; (Thrandt, DE) ;
RICHTER; Rene; (Thrandt, DE) ; WITT; Robert;
(Dresden, DE) ; Schirmer; Jens; (Dresden,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SANOFI-AVENTIS DEUTSCHLAND GMBH |
Frankfurt Am Main |
|
DE |
|
|
Family ID: |
41434755 |
Appl. No.: |
14/944778 |
Filed: |
November 18, 2015 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13319923 |
Apr 17, 2012 |
9220839 |
|
|
PCT/EP2010/056970 |
May 20, 2010 |
|
|
|
14944778 |
|
|
|
|
Current U.S.
Class: |
604/191 |
Current CPC
Class: |
A61M 5/158 20130101;
A61M 5/1483 20130101; A61M 5/148 20130101; A61M 5/282 20130101;
A61M 5/16813 20130101; A61M 5/19 20130101 |
International
Class: |
A61M 5/19 20060101
A61M005/19; A61M 5/28 20060101 A61M005/28 |
Foreign Application Data
Date |
Code |
Application Number |
May 20, 2009 |
EP |
09006823.0 |
Claims
1. An assembly for a drug delivery device comprising a dispensing
container and a reservoir container for holding a fluid medicinal
product, wherein the dispensing container and the reservoir
container are connected to one another and are in fluid
communication, and wherein the dispensing container is squeezable
for dispensing a dose of the fluid medicinal product from the
dispensing container, the dispensing container being refillable
with the fluid medicinal product from the reservoir container.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 13/319,923, filed Apr. 17, 2012, which is a
U.S. National Phase Application pursuant to 35 U.S.C. .sctn.371 of
International Application No. PCT/EP2010/056970 filed May 20, 2010,
which claims priority to European Patent Application No. 09006823.0
filed on May 20, 2009. The entire disclosure contents of these
applications are herewith incorporated by reference into the
present application.
FIELD OF INVENTION
[0002] The present invention relates to an assembly for use in a
drug delivery device.
BACKGROUND
[0003] Drug delivery devices are generally known for the
administration of a medicinal product, for example insulin, but
also for other medicinal products for self-administration by a
patient. Therefore, the drug delivery devices should be safe and
comfortable in use and should dispense an exact dose of a medicinal
product. Most of the drug delivery devices are pen-type injectors
which can dispense a pre-set dose of a medicinal product.
[0004] In some cases it is necessary for the patient to get an
exact volume of a certain medicinal product. In most commercially
available drug delivery devices there are many sources of error for
dispensing inaccuracy. One is for example the dripping out of the
needle after injection and therefore the need to keep the needle in
the skin after injection.
SUMMARY
[0005] It is an object to the present invention to provide an
assembly for use in a drug delivery device which helps to improve
the accuracy of a dispensed dose.
[0006] According to a first aspect of the present disclosure an
assembly for a drug delivery device is provided, the assembly
comprising a dispensing container and a reservoir container for
holding a fluid medicinal product, wherein the dispensing container
and the reservoir container are connected to one another and are in
fluid communication, and wherein the dispensing container is
squeezable for dispensing a dose of a fluid medicinal product from
the dispensing container, the dispensing container being refillable
with the fluid medicinal product from the reservoir container.
[0007] In the assembly, the dispensing container has an inner
volume that is equivalent to a dose, whereas the reservoir
container is holding a plurality of doses. The dose which may be
enclosed in the dispensing container can be dispensed in a single
dispensing process or in several subsequent dispensing
processes.
[0008] The dispensing container can be squeezed. While the
dispensing container is squeezed the fluid medicinal product is
dispensed.
[0009] The fluid medicinal product that may refill the dispensing
container is contained in the reservoir container. The reservoir
container and the dispensing container can have a permanent
connection. This connection is constructed such that the dispensing
container can be refilled with fluid medicinal product from the
reservoir container.
[0010] Some parts of the assembly, like for example the dispensing
container, the reservoir container or the connecting means are in
direct contact with the fluid medicinal product. These parts have
an appropriate chemical resistance towards the fluid medicinal
product that is contained. These materials can comprise PVC,
silicone rubber or fluoropolymer.
[0011] In a preferred embodiment a connecting means is connecting
an inlet of the dispensing container with a first outlet which is
located at the reservoir container.
[0012] The connecting means can for example be a tube. A tube
allows a fluid communication between the reservoir container and
the dispensing container.
[0013] The connecting means can be flexible. In case that the
connecting means is flexible it can provide a durable connection
even if the distance between the dispensing container and the
reservoir container varies during the dispensing process.
[0014] In another preferred embodiment, a first control member is
located in a connecting flow path between the dispensing container
and the reservoir container.
[0015] The first control member may be a check valve. This check
valve can regulate the flow of the fluid medicinal product.
[0016] This regulation may affect the amount of fluid medicinal
product, the time frame in which the fluid medicinal product can
flow through the connecting means and the direction in which the
fluid medicinal product can flow.
[0017] The control member may be located at the first outlet of the
reservoir container or at the inlet of the dispensing container.
Alternatively, the control member can be located somewhere between
the first outlet of the reservoir container and the inlet of the
dispensing container.
[0018] In one embodiment the first control member allows the fluid
medicinal product to flow only from the first outlet which is
located at the reservoir container in the direction of the inlet of
the dispensing container.
[0019] In this embodiment a check valve may find use, wherein the
medicinal product can flow through an opening in the check valve.
The fluid medicinal product can only flow through the opening in a
certain direction after a certain pressure is applied to the check
valve.
[0020] Due to the one-way behavior of the check valve a reflow of
medicinal product from the dispensing container into the reservoir
container can be effectively avoided. This leads to an improved
accuracy of the dosage dispensed from the dispensing container
because the enclosed volume of the fluid medicinal product in the
dispensing container is exactly defined.
[0021] In another embodiment a second control member is located in
a dispensing flow path of a second outlet which is located at the
dispensing container.
[0022] The dispensing flow path of the second outlet which is
located at the dispensing container is directed towards the
dispensing end of the assembly. A needle unit can be attached to
this dispensing end.
[0023] The second control member may be a check valve which allows
the fluid medicinal product to flow only in the dispensing
direction which means from the dispensing container in the
direction where the needle unit might be attached to the
assembly.
[0024] In another preferred embodiment the second control member is
preventing in taking of air or fluid or tissue into the dispensing
container via the dispensing flow path.
[0025] In taking of air or of tissue through the second outlet
would lead to a dose inaccuracy for the next dose which is
dispensed from the assembly. Only the fluid medicinal product from
the reservoir container should refill the dispensing container,
therefore the second control member should prevent that dispensed
fluid or blood flows back into the dispensing container.
[0026] One advantage of having a second control member is that the
same volume of fluid medicinal product is enclosed inside the
dispensing container before a dispensing process is started and
after the fluid medicinal product dispensed during this dispensing
process is refilled from the reservoir container.
[0027] In one preferred embodiment the second control member allows
the fluid medicinal product to be dispensed through the second
outlet which is located at the dispensing container.
[0028] The second outlet can be located diametrically opposed to
the inlet of the dispensing container. In particular, a pen-type
injector can be formed through a linear alignment of the components
of the assembly.
[0029] While dispensing the fluid medicinal product the second
control member opens the flow path in direction of a needle unit
which might be attached. The injection takes place by means of the
attached needle unit.
[0030] In another preferred embodiment the dispensing container
comprises a hollow body.
[0031] The hollow body can for example be formed as a hollow
sphere. The inner volume of this hollow body is equivalent to the
maximum volume that can be dispensed at a time.
[0032] The dispensing container can also be pear-shaped.
[0033] In one preferred embodiment the dispensing container is
elastically deformable for dispensing a dose of the fluid medicinal
product.
[0034] To dispense the fluid medicinal product, a force is applied
by a means that deforms the dispensing container. This force leads
to an increasing deformation of the dispensing container and
therefore to an increasing dispensed volume of the fluid medicinal
product.
[0035] Due to the elastic condition of the dispensing container
this deformation is reversible. As the force is no longer applied
to the dispensing container, it returns to its original shape and
size.
[0036] In another embodiment the assembly comprises a housing and
an actuator which is moveable with respect to the housing.
[0037] Inside the housing, a base frame can be located which is
moveable with respect to the housing. The actuator can be located
at the distal end of that base frame. This actuator can be located
between the reservoir container and the dispensing container.
However, any other suitable position for the actuator is
possible.
[0038] The housing forms a good protection for the dispensing
container and for the reservoir container. The reservoir container
can be attached to the base frame.
[0039] In one preferred embodiment the actuator is located at the
dispensing container for dispensing the fluid medicinal
product.
[0040] The actuator applies a force to the dispensing container.
Due to the applied force the fluid medicinal product is dispensed.
Therefore a mechanical contact is needed between the actuator and
the dispensing container to apply the force to the dispensing
container.
[0041] In another preferred embodiment the actuator squeezes the
dispensing container and is dispensing the fluid medicinal
product.
[0042] The actuator applies a force to the dispensing container as
it is pushed towards the dispensing container. The container is
deformed and the fluid medicinal product which is contained inside
the dispensing container can be dispensed through an outlet.
[0043] The force which is applied to the dispensing container can
be generated mechanically or electrically. Therefore, a dispensing
means comprising a spring can be located at the distal end of the
base frame. The dispensing means may be connected to the base
frame. The actuator can be moved electrically or by being actuated
by the user. The actuator can be moved back to the starting
position by means of the spring.
[0044] The dispensing container can dispense a predefined dose of
the fluid medicinal product.
[0045] In another preferred embodiment the assembly comprises a
dispensing container which is expanding after dispensing the fluid
medicinal product. Through the expansion a depression is created in
the dispensing container which is able to intake fluid medicinal
product from the reservoir container.
[0046] After the fluid medicinal product is dispensed, a depression
is created inside the dispensing container. As no air can be
intaken by the second outlet located at the dispensing container by
means of a check valve, only fluid medicinal product from the
dispensing container can flow into the dispensing container.
[0047] The depression is formed by means of the elastically
deformable dispensing container. After being deformed the material
tends to return to its original shape and size. The fluid from the
reservoir container flows into the dispensing container because of
the low pressure inside the dispensing container. During this
re-shaping and refilling process the actuator and therefore the
base frame may be pushed back to its starting position.
[0048] Another advantage of the depression is that the dripping
time of a needle after the injection is reduced.
[0049] In another preferred embodiment the assembly comprises
additional means adapted to refill the dispensing container after
dispensing the fluid medicinal product.
[0050] The additional means may for example be a pump. The pump is
attached to refill the dispensing container.
BRIEF DESCRIPTION OF THE FIGURES
[0051] In the following, the invention is described in further
detail with reference to the drawings, wherein
[0052] FIG. 1 shows a view of the assembly in a starting
position.
DETAILED DESCRIPTION
[0053] In FIG. 1, identical reference numerals denote identical or
comparable components.
[0054] FIG. 1 shows an assembly according to the present
disclosure. The assembly is surrounded by a housing 10. The housing
10 comprises a right side member 12, a left side member 14, a
distal bar 16, a first bar 18, a second bar 20 and a proximal bar
22. All of these bars 16, 18, 20, 22 comprise a central bore.
[0055] A base frame 30 is arranged inside the housing 10 which
comprises a bearing in which the base frame 30 is movable in axial
direction with respect to the housing 10. The base frame 30
comprises a right longitudinal bar 32, a left longitudinal bar 34,
a front face 36 of the right longitudinal bar, a front face 38 of
the left longitudinal bar, an actuator bar 40, a support bar 42 and
a proximal bar 44 of the base frame.
[0056] The actuator bar 40 comprises a bore. A tube 64 is arranged
inside this bore. A check valve is arranged inside the tube 64. The
tube 64 is connecting the reservoir container 70 and the dispensing
container 60.
[0057] A needle unit 52 is adapted to the distal end 50 of the
assembly. The needle unit 52 is seated over a second control member
54.
[0058] The second control member 54 is located in the flow path
between an intermediate member 56 and the needle unit 52. The first
bar 18 of the housing 10 is located between the intermediate member
56 and the outlet 58 of the spherical body of the dispensing
container 60. The center of the first bar 18 comprises a bore to
allow for a flow path between the dispensing container 60 and the
needle unit 52 passing through the first bar 18.
[0059] At the proximal end 74 of the dispensing container 70, an
actuator bar 40 is located which comprises a small bore to define
an aperture for a tube 64 which is connecting the dispensing
container 60 with a reservoir container 70. On the right and on the
left side of the actuator bar 40 the front faces 36, 38 of two
longitudinal bars are shown. These front faces 36, 38 are not flush
with the surface of the actuator.
[0060] A first control member 66 is arranged at a first outlet 68
located at the reservoir container 70. The reservoir container 70
is surrounded and connected to a support bar 42 of the base frame
30 which is comprising a central opening. This ensures a secure
connection of the reservoir container 70 to the housing 10.
[0061] At the proximal bar 44 of the base frame 44, dose dispensing
means 76 are shown which comprise a spring 72.
[0062] By pressing the dose dispensing means 76, the base frame 30
is pushed towards the distal end 50 of the housing 10. This
movement causes a compression of the dispensing container 60 and
liquid medicinal product is dispensed through the needle unit
52.
[0063] The distal movement is stopped by the abutment of the front
faces 36, 38 of the longitudinal bars of the base frame 30 with the
first bar 18 of the housing 10. The abutment indicates that the
maximum dosage of the medicinal product is dispensed. This is the
final position of the base frame during the dispensing process.
[0064] Due to the elastic behavior of the dispensing container 60,
the dispensing container 60 is withdrawing fluid medicinal product
from the reservoir container 70 by suction. This process ends after
the dispensing container 60 has reached its original shape.
[0065] The check valve 54 ensures that just the fluid medicinal
product from the reservoir container 70 is flowing into the
dispensing container 60 by closing the dispensing flow path in
proximal direction 74. This is an effective method to prevent the
intaking of air, tissue or blood into the dispensing container
60.
[0066] The spring 72 at the proximal end 74 of the assembly
together with the elastic behavior of the dispensing container 60
after dispensing the fluid medicinal product enables the base frame
30 to be pushed back in proximal direction 74. After the dispensing
container 60 is refilled, the movement of the base frame 30 ends in
its starting position.
[0067] The term "drug" or "medicament", as used herein, means a
pharmaceutical formulation containing at least one pharmaceutically
active compound,
[0068] wherein in one embodiment the pharmaceutically active
compound has a molecular weight up to 1500 Da and/or is a peptide,
a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody,
an enzyme, an antibody, a hormone or an oligonucleotide, or a
mixture of the above-mentioned pharmaceutically active
compound,
[0069] wherein in a further embodiment the pharmaceutically active
compound is useful for the treatment and/or prophylaxis of diabetes
mellitus or complications associated with diabetes mellitus such as
diabetic retinopathy, thromboembolism disorders such as deep vein
or pulmonary thromboembolism, acute coronary syndrome (ACS),
angina, myocardial infarction, cancer, macular degeneration,
inflammation, hay fever, atherosclerosis and/or rheumatoid
arthritis,
[0070] wherein in a further embodiment the pharmaceutically active
compound comprises at least one peptide for the treatment and/or
prophylaxis of diabetes mellitus or complications associated with
diabetes mellitus such as diabetic retinopathy,
[0071] wherein in a further embodiment the pharmaceutically active
compound comprises at least one human insulin or a human insulin
analogue or derivative, glucagon-like peptide (GLP-1) or an
analogue or derivative thereof, or exedin-3 or exedin-4 or an
analogue or derivative of exedin-3 or exedin-4.
[0072] Insulin analogues are for example Gly(A21), Arg(B31),
Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28),
Pro(B29) human insulin; Asp(B28) human insulin; human insulin,
wherein proline in position B28 is replaced by Asp, Lys, Leu, Val
or Ala and wherein in position B29 Lys may be replaced by Pro;
Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human
insulin and Des(B30) human insulin.
[0073] Insulin derivates are for example B29-N-myristoyl-des(B30)
human insulin; B29-N-palmitoyl-des(B30) human insulin;
B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin;
B28-N-myristoyl LysB28ProB29 human insulin;
B28-N-palmitoyl-LysB28ProB29 human insulin;
B30-N-myristoyl-ThrB29LysB30 human insulin;
B30-N-palmitoyl-ThrB29LysB30 human insulin;
B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;
B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;
B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and
B29-N-(w-carboxyheptadecanoyl) human insulin.
[0074] Exendin-4 for example means Exendin-4(1-39), a peptide of
the sequence
H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Gl-
u-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly--
Ala-Pro-Pro-Pro-Ser-NH2.
[0075] Exendin-4 derivatives are for example selected from the
following list of compounds:
H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),
[0076] wherein the group -Lys6-NH2 may be bound to the C-terminus
of the Exendin-4 derivative;
[0077] or an Exendin-4 derivative of the sequence
H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,
des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25]
Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,
des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,
H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]
Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(S1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2;
[0078] or a pharmaceutically acceptable salt or solvate of any one
of the afore-mentioned Exedin-4 derivative.
[0079] Hormones are for example hypophysis hormones or hypothalamus
hormones or regulatory active peptides and their antagonists as
listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine
(Follitropin, Lutropin, Choriongonadotropin, Menotropin),
Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,
Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
[0080] A polysaccharide is for example a glucosaminoglycane, a
hyaluronic acid, a heparin, a low molecular weight heparin or an
ultra low molecular weight heparin or a derivative thereof, or a
sulphated, e.g. a poly-sulphated form of the above-mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof.
An example of a pharmaceutically acceptable salt of a
poly-sulphated low molecular weight heparin is enoxaparin
sodium.
[0081] Pharmaceutically acceptable salts are for example acid
addition salts and basic salts. Acid addition salts are e.g. HCl or
HBr salts. Basic salts are e.g. salts having a cation selected from
alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other
mean: hydrogen, an optionally substituted C1-C6-alkyl group, an
optionally substituted C2-C6-alkenyl group, an optionally
substituted C6-C10-aryl group, or an optionally substituted
C6-C10-heteroaryl group. Further examples of pharmaceutically
acceptable salts are described in "Remington's Pharmaceutical
Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing
Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of
Pharmaceutical Technology.
[0082] Pharmaceutically acceptable solvates are for example
hydrates.
* * * * *