Silicone composition, use of the silicone composition in a product, and product made of the silicone composition

Abstract

The present invention relates to a silicone composition, in particular for products used in medicine and / or the pharmaceutical industry, for example for medical products and combination products, comprising a silicone elastomer and an additive, wherein a) the additive has a layered silicate, or b) the additive has silicic acid and a layered silicate, and wherein the additive has a surface modified by at least one functional group. Further aspects of the invention relate to a use of a silicone composition and to a product used in medicine and / or the pharmaceutical industry.

Description

[0001] Silicone composition, use of the silicone composition in a product and product made from the silicone composition

[0002] The invention relates to a silicone composition, in particular for products for the medical technology and / or pharmaceutical industry, for example for medical devices and combination products that combine a medical device with a drug or active ingredient. The silicone composition and products made therefrom can be used, for example, in the human and / or veterinary medical field. The invention also relates to the use of the silicone composition in a product for the medical technology and / or pharmaceutical industry, for example in a medical device, and to such a product made from the silicone composition. The product can be used in particular as a medical device and / or combination product in the medical technology and / or pharmaceutical industry, for example in the context of Good Manufacturing Practice (GMP).

[0003] Silicones, especially silicone elastomers, have proven themselves in many applications, particularly in medical technology, due to their good biocompatibility. The poor gas barrier properties of silicone elastomers are particularly problematic for the medical technology and pharmaceutical industries. The potential for gas exchange limits the use of this material in medical devices, combination products, and products for the pharmaceutical industry, for example, in GMP environments, particularly for drug storage and / or administration. To improve gas barrier properties, petroleum-based components are added, for example, or additional barrier layers or coatings are used. This reduces the biocompatibility of silicone elastomers. Additional components or layers also limit processability and require higher manufacturing costs.

[0004] It is the object of the present invention to improve a silicone composition, in particular with regard to its gas barrier properties.

[0005] This object is achieved by a silicone composition having the features specified in claim 1. It has been recognized that an additive based on silica and phyllosilicates or layered silicates improves the gas barrier properties of a silicone elastomer. The gas barrier is increased through functional bonds and intermolecular interactions of the additive to or with the silicone elastomer. The other material properties of the silicone elastomer, in particular the processability in extrusion and / or injection molding processes, are advantageously retained; they are in particular not or hardly affected by the additive. The result is a silicone composition with good biocompatibility, which is particularly suitable for products for the medical technology and / or pharmaceutical industries, in particular for medical devices and combination products.Adequate gas barrier properties are guaranteed without petroleum-based additives and / or additional barrier layers or coatings.

[0006] According to the invention, the additive comprises a layered silicate or alternatively silica and a layered silicate, wherein the additive has a surface modified with at least one functional group.

[0007] Advantageously, the silicone composition according to the invention does not require purely petroleum-based additives and / or additional barrier layers, which are produced, for example, by co-extrusion, or barrier coatings that may be susceptible to abrasion. The addition of the functionalized additives eliminates the need for further process steps to improve the gas barrier, such as additional coating or co-extrusion. This can reduce manufacturing costs. Furthermore, the gas barrier can be irreversible using an additive according to the invention.

[0008] Further advantageously, the silicone composition according to the invention has reduced gas permeability and improved swellability.

[0009] An additive based on silica and a phyllosilicate or a layered silicate is to be understood in such a way that a main component of the additive is a silica, a layered silicate, and / or a derivative thereof. Silica is an oxygen acid of silicon. Silica exists in particular as monosilicic acid (also called orthosilicic acid) and / or (poly)condensation thereof, for example as disilicic acid (or pyrosilicon), trisilicic acid, or cyclic silica. Also based on silica are, in particular, amorphous colloids (silica sol), polysilicic acids, silicic acid esters, and / or silicic acid anhydrides, for example, silicas. Cryptocrystalline and / or amorphous silicas (CAS No. 7631-86-9) are particularly suitable. Silicates are salts of silicas. Particularly suitable are layered silicates, for example talc (talc, CAS No. 14807-96-6), kaolin (CAS No. 92704-41-1) and / or kaolinite (CAS No. 1318-74-7).

[0010] According to one embodiment, the layered silicate is in calcined and / or uncalcined form.

[0011] Calcination is the conversion of substances into a lime-like substance by heating them in air or an oxygen-containing atmosphere. It also includes the heating, especially by firing, of minerals containing calcium and magnesium carbonate with the aim of dehydrating them.

[0012] According to one embodiment, the silicone composition does not contain any purely petroleum-based additives and / or barrier layers or barrier coatings. Additionally or alternatively, the silicone composition is free of purely petroleum-based additives and / or barrier layers or barrier coatings.

[0013] The silicone composition according to the invention can have a gas permeability which is reduced by at least 30%, in particular by at least 50%, compared to the gas permeability of the silicone elastomer.

[0014] Such a silicone composition has proven particularly suitable for medical technology applications and applications in the pharmaceutical industry. The silicone composition preferably has a gas permeability that is reduced by 30% to 80%, in particular by 40% to 80%, in particular by 45% to 65%, for example between 50% and 60%, compared to the gas permeability of the non-additive silicone elastomer. The gas permeability can be reduced, in particular, for oxygen and / or water vapor.

[0015] The following are exemplary values ​​for the gas permeability of a silicone composition using its oxygen permeability as an example. Gas permeability is quantified as the permeation rate R, which determines the volume of escaping gas per unit time (days, d), taking into account the wall thickness of the test specimen. For simplicity, the unit of permeation rate R is abbreviated to P: [R] = cm 3 ■ pm • nr 2 ■ d 1 = P. Suitable exemplary silicone elastomers, for example addition-curing platinum-catalyzed solid silicone rubbers, have a permeation rate R between 2.7 • 10 7 P and 4.1 ■ 10 7 P. With the additive according to the invention, permeation rates R between 1 ,0 ■ 10 7 P and 2.4 ■ 10 7 P can be achieved, especially between 1 ,0 ■ 10 7 P and 2.0 ■ 10 7 P, especially between 1 ,1 ■ 10 7P and 1 ,6 - 10 7 P.

[0016] The swelling behavior in oils or organic compounds can also be improved by at least 30% in the silicone composition according to the invention. For example, in hexane, silicone rubber with 80 phr containing a methacrylic or alkyl-functionalized additive gains 60% less weight compared to the unadditized material. At 35 phr, the material exhibits 49% less weight gain. This makes components less susceptible to liquid media and can withstand higher pressures (bursting pressures, shear pressures) and mechanical stresses in fluid handling applications (hoses) and as seals. A significant improvement can also be seen compared to oils:

[0017] Exemplary improvement in

[0018] 3M Novec 7500 HFE oil: 36% (35 phr), 47% (80 phr)

[0019] Evonik TEGOSOFT DEC Oily Emulsion: 37% (35 phr), 63% (80 phr)

[0020] Paraffin oil (baby oil): 38% (35 phr), 52% (80 phr)

[0021] Liveo 360 Medical Fluid 100 cSt: 43% (35 phr), 70% (80 phr).

[0022] According to one embodiment, the silicone elastomer is a liquid silicone rubber or a solid silicone rubber, preferably an addition-curing, in particular platinum-catalyzed, silicone elastomer.

[0023] Such a silicone composition has proven particularly suitable for industrial production. Liquid silicone rubber (LSR) and / or solid silicone rubber (High Consistency Rubber, HCR) are particularly suitable for medical devices and combination products. Addition-curing platinum-catalyzed silicone elastomers have proven particularly advantageous. Silicone elastomers, especially HTV silicone elastomers (high-temperature curing silicone elastomers) with very low viscosity in the unvulcanized state, are particularly advantageous. Silicone elastomers with dynamic viscosities (10 s), for example, are particularly suitable. -1) of less than 1,000,000 mPas, in particular less than 500,000 mPas. Particularly suitable silicone elastomers can, for example, have a Mooney viscosity of less than 50 Mooney units (MU), in particular in the range of 20 MU to 40 MU. The Mooney viscosity is measured in particular according to DIN ISO 289-1:2018-12.

[0024] According to one embodiment, the additive is admixed to the silicone elastomer in a proportion of 10 phr to 120 phr, in particular of 40 phr to 80 phr, in particular of 40 phr to 75 phr.

[0025] Such an additive content has proven particularly beneficial for improving silicone compositions, particularly with regard to their gas barrier properties. Parts per hundred rubber (phr) refers to the mass fractions of the individual components in a recipe for an elastomer composition. The additive content can be used to tailor the gas permeability to the desired application. The higher the additive content, the greater its positive influence on the gas barrier properties. However, as the additive content increases, so does the influence of the additive on the mechanical properties of the silicone composition. As the additive content increases, processing also becomes more difficult. Additive content of 10 phr to 120 phr, in particular 40 phr to 80 phr, and especially 40 phr to 75 phr, has proven particularly suitable.The additive content can be adjusted depending on the respective silicone elastomer.

[0026] According to one embodiment, the additive comprises, in particular, cryptocrystalline and / or amorphous silica (CAS No. 7631-86-9), preferably consisting essentially thereof. The silica, in particular the cryptocrystalline silica and / or amorphous silica, can preferably be surface-functionalized. The additive can simply be added to the silicone elastomer.

[0027] According to one embodiment, the layered silicate comprises or is talc, kaolin and / or kaolinite.

[0028] This embodiment has proven to be particularly suitable, in particular for reducing gas permeability. Talc (Talc, CAS No. 14807-96-6), kaolinite (CAS No. 1318-74-7) and / or kaolin (CAS No. 92704-41-1), in particular talc and / or kaolinite, have proven to be particularly suitable layered silicates. The additive can in particular consist essentially of the layered silicate, preferably of talc, kaolinite and / or calcined kaolin. Silicates are salts and esters of orthosilicic acid and their condensates. Layered silicates, in particular in the form of talc and / or kaolinite, have proven to be particularly suitable for improving the gas barrier.

[0029] The additive particularly preferably comprises a layered silicate, in particular talc, with a functionalized surface, preferably a surface functionalized with organofunctional silanes. The surface functionalization can be carried out in particular with methacrylic, alkyl, and / or vinyl groups. The additive can consist of talc or contain other components. For example, the additive can be a mixture of functionalized talc (talc), in particular with a proportion of approximately 90 wt.%, and one or more minerals, in particular with a proportion of approximately 10 wt.%.

[0030] The additive can consist in particular of silica, in particular cryptocrystalline and / or amorphous silica, and the phyllosilicate, in particular talc, kaolinite and / or kaolin, preferably being a mixture of the silica and the phyllosilicate. For example, the additive can be a mixture of cryptocrystalline and / or amorphous silica with kaolinite. The silica can, for example, have a proportion of 60 wt.% to 70 wt.% in the additive. The phyllosilicate, in particular talc, kaolin and / or kaolinite, can, for example, have a proportion of 15 wt.% to 40 wt.%, in particular between 17 wt.% and 25 wt.%, in the additive. In addition, the additive can contain amorphous mineral phases, for example with a proportion between 8 wt.% and 10 wt.%, and / or accompanying minerals, for example with a proportion of approximately 5 wt.%.

[0031] According to one embodiment, the modified surface is modified with an organofunctional silane, for example, with an alkyl functional group, vinyl functional group, and / or methacrylic functional group. The surface can be modified, for example, by organic functional groups applied by silanization.

[0032] Such a silicone composition has particularly good gas barrier properties. The surface modified with functional groups is also referred to as a functionalized surface. The functionalized surface strengthens the functional bond to increase the gas barrier. Alkyl functional groups have proven to be particularly suitable organofunctional groups. Other suitable examples of functional groups are methacrylic functional groups and / or vinyl functional groups.

[0033] According to one embodiment, the additive consists of, in particular only of, layered silicate or alternatively of, in particular only of, silica and layered silicate.

[0034] According to one embodiment, the additive consists of or comprises silica and phyllosilicate(s), or alternatively, phyllosilicate(s), wherein the phyllosilicates, e.g., talc, kaolin, or kaolinite, are present in calcined and / or uncalcined form. The phyllosilicates and the silica are characterized by surface modification. The organic functional groups applied, for example, by silanization, can be methacrylic, vinyl, or alkyl groups.

[0035] According to one embodiment, the organic functional groups are methacrylic, vinyl or alkyl groups.

[0036] According to one embodiment, the functional group comprises or is at least one of the groups methacrylic group, vinyl group or alkyl group.

[0037] According to one embodiment, the alkyl groups comprise chain lengths from C = 1 (methyl) to C = 30 (triacontanyl). In particular, chain lengths of C = 1 and / or C = 30 are possible. Chain lengths of C = 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, and / or 18 are possible. Chain lengths from C = 20 to C = 24 and / or from C = 26 to C = 28 are possible.

[0038] According to one embodiment, the layered silicate comprises or is a layered silicate of class 9. EC and / or 9.ED classified according to the Strunz classification.

[0039] The Strunz classification is the crystal-chemical classification of minerals according to their chemical composition and crystalline structure. The Strunz classification can be found, for example, in Hugo Strunz and Ernest H. Nickel: Strunz Mineralogical Tables: Chemical-Structural Mineral Classification System. 9th edition. E. Schweizerbart'sche Verlagsbuchhandlung (Nägele and Obermiller), Stuttgart.

[0040] 2001 , ISBN 3-510-65188-X, the contents of which are hereby incorporated by reference.

[0041] According to one embodiment, the silicone composition consists of a silicone elastomer and an additive, wherein a) the additive comprises a layered silicate, or b) the additive comprises silica and a layered silicate, and wherein the additive has a surface modified with at least one functional group.

[0042] According to one embodiment, the silicone composition consists of a silicone elastomer and an additive, wherein a) the additive consists of a layered silicate, or b) the additive consists of silica and a layered silicate, and wherein the additive has a surface modified with at least one functional group.

[0043] The following exemplary additives have proven particularly suitable for the silicone composition, in particular for products for medical technology and / or the pharmaceutical industry, for example for use in medical devices and combination products: a) Mixture of 60-80 wt.% cryptocrystalline silica (CAS No. 7631-86-9) with methacrylic functionalization and 8-10 wt.% amorphous silica (CAS No. 7631-86-9) with methacrylic functionalization and 15-30 wt.% kaolinite (CAS: 1318-74-7) with methacrylic functionalization. The mixture can preferably be present in the silicone composition at a concentration of 5 phr to 30 phr. b) Mixture of 60-80 wt% cryptocrystalline silica (CAS No. 7631-86-9) with alkyl functionalization and 8-10 wt% amorphous silica (CAS No. 7631-86-9) with alkyl functionalization and 15-30 wt% kaolinite (CAS: 1318-74-7) with alkyl functionalization.The mixture can preferably be present in the silicone composition at a concentration of 5 phr to 30 phr. c) Vinyl- and / or alkyl- and / or methacryl-functionalized talc (CAS: 14807-96-6). The functionalized talc can preferably be present in the silicone composition at a concentration of 20 phr to 120 phr, in particular from 20 phr to 80 phr, preferably from 50 phr to 80 phr. d) Vinyl-functionalized mixture of 50 wt.% to 80 wt.% cryptocrystalline silica (CAS No. 7631-86-9), 20 wt.% to 40 wt.% calcined kaolinite (CAS: 92704-41-1) and 5 wt.% to 15 wt.% amorphous silica (CAS No. 7631-86-9), optionally with accompanied mineral phases (3 wt.% to 12 wt.%). e) A mixture of the additives mentioned under a) and c) or b) and c) in a ratio of 5:80 to 120:80. f) A mixture of the additives mentioned under c) and d) in a ratio of 20:80 to 80:20.g) Functionalized silica, in particular cryptocrystalline and / or amorphous silica (CAS No. 7631-86-9). The functionalization can be carried out, for example, with methacrylic, alkyl, and / or vinyl groups. h) A mixture of silica, in particular cryptocrystalline and / or amorphous silica (CAS No. 7631-86-9), with kaolinite, in particular with a silica content of between 60 wt.% and 70 wt.% and / or a kaolinite content of between 17 wt.% and 25 wt.%. The mixture can in particular be surface-modified, preferably with at least one of the following functional groups: methacrylic-functional groups, alkyl-functional groups, and / or vinyl-functional groups. The mixture can additionally comprise amorphous mineral phases, in particular with a content of between 8 wt.% and 10 wt.%, and / or accompanying minerals, in particular with a content of about 5 wt.%. i) A mixture of talc (talc, CAS No. 14807-96-6), in particular with a proportion of about 90 wt.-%, and an admixture containing silica, in particular cryptocrystalline and / or amorphous silica (CAS No. 7631-86-9), and kaolinite (CAS No. 1318-74-7), wherein the admixture in particular has a proportion of approximately 10 wt.%. The admixture can in particular have a silica proportion between 60 wt.% and 70 wt.% (based on the admixture) and / or a kaolinite proportion between 17 wt.% and 25 wt.% (based on the admixture). The admixture can additionally have amorphous mineral phases, in particular with a proportion between 8 wt.% and 10 wt.% (based on the admixture), and / or accompanying minerals, in particular with a proportion of approximately 5 wt.% (based on the admixture). The use according to claim 18 leads to particularly advantageous products for the medical technology and / or pharmaceutical industries, in particular to particularly advantageous medical devices and / or combination products.These products, particularly medical devices and / or combination products, combine the advantages of silicone, particularly its biocompatibility, with good gas barrier properties. Additional barrier layers and / or coatings and / or petroleum-based fillers are not required. The products, particularly medical devices, can be manufactured using processes proven for silicone, such as extrusion and injection molding.

[0044] The same applies to the product, in particular a medical device, according to claim 19. The product can be, in particular, a medical and / or pharmaceutical tube, a medical and / or pharmaceutical stopper, for example a syringe stopper, an injection stopper, and / or a closure stopper, for example for storing medications, especially in vials. A pharmaceutical tube is also referred to as a pharmaceutical tube.

[0045] Further features, advantages, and details of the invention will become apparent from the following description of exemplary embodiments with reference to the figures. They show:

[0046] Fig. 1 schematically shows an embodiment of a medical device in the form of a tube and

[0047] Fig. 2 schematically shows an embodiment of a medical device in the form of a syringe stopper.

[0048] Fig. 1 shows a medical device in the form of a tube 1. The tube 1 has a tube wall 2 that defines a tube lumen 3. The tube wall 2 is formed from a silicone composition. No additional layers, in particular additional gas barrier layers and / or coatings, are present.

[0049] The silicone composition of the hose wall 2 comprises a silicone elastomer and an additive based on silica and / or silicates, in particular phyllosilicates. The silicone elastomer is a liquid silicone rubber or a heat-curing silicone rubber. The additive is added to the silicone elastomer in a proportion of 10 phr to 120 phr, in particular 20 phr to 80 phr. This reduces the gas permeability of the silicone composition compared to the silicone elastomer by at least 30%, in particular by at least 50%.

[0050] In further embodiments, the hose can also be used for applications in the pharmaceutical industry, for example as a pharmaceutical hose.

[0051] An exemplary embodiment of a medical plug in the form of a syringe plug 4 is described below with reference to Fig. 2. The syringe plug 4 is formed in one piece from the silicone composition and therefore exhibits high biocompatibility, sealing effect, and gas barrier. The syringe plug 4 has several sealing lips 5 on its circumference.

[0052] In other embodiments, the plug can also be used for applications in the pharmaceutical industry, for example as a sealing plug.

[0053] In other embodiments not shown in the figures, other products for the medical technology and / or pharmaceutical industry can be made from the silicone composition, for example closure plugs, in particular for closing vials.

[0054] This description also covers the following aspects:

[0055] 1. Silicone composition, in particular for products for the medical technology and / or pharmaceutical industry, for example for medical devices and combination products, comprising a silicone elastomer and an additive based on silica and / or silicates.

[0056] 2. Silicone composition according to aspect 1, wherein the silicone composition has a gas permeability which is reduced by at least 30%, in particular by at least 50%, compared to the gas permeability of the silicone elastomer.

[0057] 3. Silicone composition according to one of the aforementioned aspects, wherein the silicone elastomer is a liquid silicone rubber or a solid silicone rubber, preferably an addition-curing, in particular platinum-catalyzed, silicone elastomer.

[0058] 4. Silicone composition according to one of the aforementioned aspects, wherein the additive is admixed to the silicone elastomer in a proportion of 10 phr to 120 phr, in particular of 40 phr to 80 phr, in particular of 40 phr to 75 phr.

[0059] 5. Silicone composition according to one of the aforementioned aspects, wherein the additive comprises silica, in particular consists thereof.

[0060] 6. Silicone composition according to one of the aforementioned aspects, wherein the additive comprises, in particular consists of, a layered silicate, preferably talc, kaolin and / or kaolinite.

[0061] 7. Silicone composition according to one of the aforementioned aspects, wherein the additive comprises silica and a layered silicate, in particular talc, kaolin, and / or kaolinite.

[0062] 8. A silicone composition according to any one of the aforementioned aspects, wherein the additive has a surface modified with at least one functional group, in particular with an organofunctional silane, for example with an alkyl-functional group, vinyl-functional group, and / or methacryl-functional group. 9. Use of a silicone composition according to any one of the aforementioned aspects in medical technology and / or the pharmaceutical industry, in particular in medical and / or pharmaceutical tubing, syringe stoppers, and / or closure plugs.

[0063] 10. Product for the medical technology and / or pharmaceutical industry, in particular a medical device or combination product, which comprises a silicone composition according to one of aspects 1 to 8, in particular is made therefrom.

[0064] 11. Product according to aspect 10, wherein the product is a medical and / or pharmaceutical tube, a medical and / or pharmaceutical stopper, for example a syringe stopper, injection stopper or a closure stopper.

Claims

Patent claims 1. Silicone composition, in particular for products for the medical technology and / or pharmaceutical industry, for example for medical devices and combination products, comprising a silicone elastomer and an additive, wherein a) the additive comprises a layered silicate, or b) the additive comprises silica and a layered silicate, and wherein the additive has a surface modified with at least one functional group.

2. Silicone composition according to claim 1, wherein the layered silicate is in calcined and / or uncalcined form.

3. Silicone composition according to one of the preceding claims, wherein the silicone composition does not comprise any purely petroleum-based additives and / or barrier layers or barrier coatings, and / or wherein the silicone composition is free of purely petroleum-based additives and / or barrier layers or barrier coatings.

4. Silicone composition according to one of the preceding claims, wherein the silicone composition has a gas permeability which is reduced by at least 30%, in particular by at least 50%, compared to the gas permeability of the silicone elastomer.

5. Silicone composition according to one of the preceding claims, wherein the silicone elastomer is a liquid silicone rubber or a solid silicone rubber, preferably an addition-curing, in particular platinum-catalyzed, silicone elastomer.

6. Silicone composition according to one of the preceding claims, wherein the additive is admixed to the silicone elastomer in a proportion of 10 phr to 120 phr, in particular of 40 phr to 80 phr, in particular of 40 phr to 75 phr.

7. Silicone composition according to one of the preceding claims, wherein the layered silicate comprises or is talc, kaolin and / or kaolinite.

8. Silicone composition according to one of the preceding claims, wherein the modified surface is modified with an organofunctional silane, for example with an alkyl-functional group, vinyl-functional group and / or methacrylic-functional group; and / or wherein the functional group comprises or is at least one of the groups methacrylic group, vinyl group or alkyl group, wherein the alkyl group in particular comprises chain lengths of C = 1 to C = 30.

9. Silicone composition according to one of the preceding claims, wherein the layered silicate comprises or is a layered silicate of class 9. EC and / or 9. ED classified according to the Strunz classification.

10. Silicone composition according to one of the preceding claims, wherein the additive comprises or is a mixture of 60-80 wt.% cryptocrystalline silica with alkyl functionalization and 8-10 wt.% amorphous silica with alkyl functionalization and 15-30 wt.% kaolinite with alkyl functionalization, wherein the mixture is preferably contained in the silicone composition at a concentration of 5 phr to 30 phr.

11. Silicone composition according to one of the preceding claims, wherein the additive comprises or consists of vinyl- and / or alkyl- and / or methacryl-functionalized talc, wherein the functionalized talc is preferably present in the silicone composition at a concentration of 20 phr to 120 phr, in particular of 20 phr to 80 phr, preferably of 50 phr to 80 phr.

12. A silicone composition according to any one of the preceding claims, wherein the additive comprises or is a vinyl-functionalized mixture of 50 wt% to 80 wt% cryptocrystalline silica, 20 wt% to 40 wt% calcined kaolinite and 5 wt% to 15 wt% amorphous silica.

13. A silicone composition according to any one of the preceding claims, wherein the additive comprises or is a mixture of the additives mentioned in claims 10 and 12 or in claims 11 and 12 in a ratio of 5:80 to 120:

80.

14. A silicone composition according to any one of the preceding claims, wherein the additive comprises or is a mixture of the additives mentioned in claims 12 and 13 in a ratio of 20:80 to 80:

20.

15. Silicone composition according to one of the preceding claims, wherein the additive comprises or consists of functionalized silica, in particular cryptocrystalline and / or amorphous silica, wherein the functionalization is carried out, for example, with methacrylic, alkyl and / or vinyl groups.

16. Silicone composition according to one of the preceding claims, wherein the additive comprises or is a mixture of silica, in particular cryptocrystalline and / or amorphous silica, with kaolinite, in particular with a silica content of between 60 wt.% and 70 wt.% and / or kaolinite content of between 17 wt.% and 25 wt.%, wherein the mixture is in particular surface-modified, preferably with at least one of the following functional groups: methacrylic-functional groups, alkyl-functional groups and / or vinyl-functional groups; wherein the mixture optionally comprises amorphous mineral phases, in particular with a content of between 8 wt.% and 10 wt.%, and / or accompanying minerals, in particular with a content of about 5 wt.%.

17. Silicone composition according to one of the preceding claims, wherein the additive comprises or is a mixture of talc, in particular with a proportion of about 90 wt.%, and an admixture containing silica, in particular cryptocrystalline and / or amorphous silica, and kaolinite, wherein the admixture has a proportion of about 10 wt.%; wherein the admixture optionally has a silica proportion of between 60 wt.% and 70 wt.%, based on the admixture, and / or a kaolinite proportion of between 17 wt.% and 25 wt.%, based on the admixture, wherein the admixture contains in particular amorphous mineral phases, in particular with a proportion of between 8 wt.% and 10 wt.%, based on the admixture, and / or accompanying minerals, in particular in a proportion of about 5 wt.%, based on the admixture.

18. Use of a silicone composition according to one of the preceding claims in medical technology and / or the pharmaceutical industry, in particular in medical and / or pharmaceutical tubes, syringe stoppers and / or closure plugs.

19. Product for the medical technology and / or pharmaceutical industry, in particular a medical device or combination product, which comprises a silicone composition according to one of claims 1 to 17, in particular is made therefrom.

20. Product according to claim 19, wherein the product is a medical and / or pharmaceutical tube, a medical and / or pharmaceutical stopper, for example a syringe stopper, injection stopper or a closure stopper.

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