WO2006001039A1

WO2006001039A1 - A package for at least two different products to be sold and used together

Info

Publication number: WO2006001039A1
Application number: PCT/IT2005/000044
Authority: WO
Inventors: Claudio Cavazza
Original assignee: Sigma-Tau Industrie Farmaceutiche Riunite S.P.A.
Priority date: 2004-06-23
Filing date: 2005-01-31
Publication date: 2006-01-05
Also published as: US20080272021A1; ITRM20040307A1; EP1758794A1

Abstract

The invention concerns a package (1) for at least two different products, to be sold (and used) together, said package providing at least one first housing (2) for a first pre-packaged product and a second housing for a pre-packaged product, said first and second housing being coupled to each other.

Description

A PACKAGE FOR AT LEAST TWO DIFFERENT PRODUCTS TO BE SOLD AND USED TOGETHER

The present invention relates to a package for at least two different products to be sold and used together. More specifically, the invention concerns a package of the above kind allowing to put on the market and to use together two or more products, said products having already been packaged singularly. In the following the specification will be particularly addressed to pharmaceutical products, but it also evident that said use cannot be intended as limitative of the scope of the invention. Particularly, the solution suggested according to the present invention can be used for each kind of use in the pharmaceutical, dietetic, ecc. Fields (nutraceutical, dietary supplements, ecc), such as liquid, solid (granulates, gums, tablets, capsules, bougies), hemi-solid, pressurised pharmaceutical forms, ecc. It is known that some pharmaceutical products and not exist, the intake of which can cause beside the main effect also a collateral effect. Although the collateral effect can be deemed acceptable, mainly in view of advantages obtained by the main effect, in any case the user must then intake another product for preventing or reducing the above collateral effect. At present, the general practitioner, when the main therapy is indicated or afterwards, when the collateral reveals generally prescribes the user of the product for preventing or annulling the collateral effect. Moreover, two products are sold separately with the pharmacy, both at the same time and separately. Particularly, making reference to some pharmaceutical products, it is for example known the importance of combining a statine with a carnitine, or any other useful drug for counterbalancing, treating or preventing the collateral effects of statine; as well as the combination of a vitamin or of a poli-vitaminic complex with an antibiotic therapy; as well as combining an anti-ulcer product with an anti-inflammatory product. Making particularly reference to some specific works and scientific publications (including patents and patent applications), it is known that statine (simvastatin, lovastatin, pravastatin, fluvastatin, and their analogues) are inhibitors of hidroxi-methy-glutaril coenzyme A reductase (HMG CoA). By the inhibition of this enzyme, they reduce the synthesis of cholesterol at the hepatic level (Lancet 1994; 334: 1383- 1389). In order to compensating the reduction of intracellular cholesterol, hepatic cells express more receptors for lipoproteins of series LDL and VLDL, so that they are removed from the blood circulation. Furthermore, statines induce a lower absorption at the intestinal level of cholesterol deriving from the diet and a reduced expression of apoproteine B present in low-density lipoproteins (LDL). Statine are better tolerated with respect to other hypocholesterolising agents, but they have some disadvantages: the more frequent collateral effects caused by these dugs are gastrointestinal disturbs, cutaneous rushes and hemicranias. Some patients had sleep disturbs (EJ Schaffer, N Engl J Med, 319: 1222, 1988; Lancet, 339: 547, 29 February 1992), while meaningful increase of basal values have been observed in patients subjected to treatment with statine doses of 40 mg (Kg (Schweiz Med Wochenschr 1991 Jun 29; 121 (26):977-83). Furthermore, in patients subjected to treatment with simvastatin collateral effects have been noticed, associated with myopathia, rhabdomyolisys, muscular pain and increase of serumal SK and of activity of LDH [Dedlypere j. P. & Vermeulen A. (1991) Ann. Intern. Med. 114: 342; Bizzarro N. et al. (1992) Clin. Chem. 38:1504]. In EP Patent 0 383 432 it is described the combination of an HMG-CoA reductase inhibitor with coenzyme Q10 for treatment of myopathia of skeletal musculature caused by statine. It has demonstrated that statine cause a reduction of mortality due to coronary cardiac pathologies, but, on the other hand, it has been registered an increase of mortality caused by other events, such as tumour or traumas, in patients subjected to the above therapy (Davey- Smith G., Song F., Sheldon T. A., Cholesterol lowering and mortality: the importance of considering initial level at risk. BMJ 1993; 306:1367-1373; Ravnshov U.; Cholesterol lowering trials in coronary heart disease: frequency of citation and outcome. BMJ 1992; 305:15-19). Young rats were subjected to treatment with different hypocholesterolising agents (simvastatin, lovastatin e pravastatin) show symptoms of myopathia, when high doses of simvastatin are used (Reijneveld J. C. et al., 1976 Pediatr. Res. 39: 1028-1035). Furthermore, Bhuiyan et al. (Bhuiyan J. & Soccombe D. W. 1996 Lipids 31 :867-870) have demonstrated that administering of lovastatin to rabbits causes a noticeable diminution of hepatic, cardiac and of skeletal musculature L-camitine. Results of experiments carried out on animals and human beings suggest that, in order to reduce the cholesterol levels, pharmacological treatment with statine should be adopted only for high- risk patients for short-term coronary pathologies (JAMA, 1996; 275: 55- 60). They are also known the hypo-cholesterolising and hypo-tri- glycerimising effects of some alcanoil carnitines, particularly of acetyl L- carnitine. US patent n⁰ 4,268,524 describes a therapeutical method for increasing the high density lipoprotein (HDL) levels in such a way to selectively reduce the ratio LDL+VLDL:HDL in plasma of cardiovascular pathology risk patients, having a particularly high ratio. This method provides the daily administering of a dose of 5-50 mg/kg of alcanoil- carnitine or of one of its pharmaceutically acceptable salts. International Patent Application WO 099/01126 describes the use of alcanoil-carnitine in combination with statine for treatment of pathologies correlate with lipidic metabolism disorders. WO 099/01126 does not describe or suggest that L-carnitine or alcanoil L-camitine can exert a protective action on collateral effects or on toxicity induced by statine. It has been surprisingly found that the co-ordinated use of L- carnitine and one between alcanoil L-carnitine, wherein linear or branched alcanoil has between 2 and 6 carbon atoms, or one of their pharmaceutically acceptable salts, and of one statine exerts a protective action against collateral effects or toxicity caused by statine. Known absence of collateral effects and toxicity of L-carnitine and of alcanoil L-carnitine and protective action of the same for toxicity and unwished effects caused by statine, allows using higher doses of statine with respect to those usually administered (10/20 mg/day). Co-ordinated use is particularly useful and safe for treatment of iper-cholesterolemic and/or iper-triglyceridemic patients with high-risk f cardiovascular pathologies either within short, medium or long term. In fact, thanks to the protective effect exerted by L-carnitine or by alcanoil L-carnitine, it has been revealed the possibility of using high doses of statine with respect to those usually employed for human therapy, while dose of L-carnitine or of alcanoil L-carnitine can be between 100 and 3000 mg/day. By "co-ordinated use" of the above compounds it is meant, indifferently, (i) the co-administering, i.e. administering at the same time of L-carnitine and of one of the above aicanoil L-carnitine or of one of their pharmaceutically acceptable salts and of a statine, or (ii) administering of one composition comprising the above active principles in combination and mixed, along with suitable excipients. Said co-administering implies also the packaged or manufactured product, in such a way to comprise the different administered forms of L-carnitine or of one of the above alcanoil L-carnitine or of one of their pharmaceutically acceptable salts and of a statine, with specific instructions for co-ordinated and simultaneous intake of the active principles according to a dosage regime set by a treatment indicated by the doctor on the basis of the patient conditions. Thus, the invention aims to provide a package allowing to sell and use together two (or more) different products, such as those mentioned in the above, in such a way that the user does not have the risk of not properly coupling at the moment of the purchase or during the treatment said two (or more) different products. It is therefore specific object of the present invention a package for at least two different products, to be sold (and used) together, said package providing at least one first housing for a first pre-packaged product and a second housing for a pre-packaged product, said first and second housing being coupled each other. Preferably, according to the invention, said first and second housings provide a first and a second product for completing the particular therapeutical or nutritional cycle. Particularly, according to the invention, said products can be liquid, solid, pharmaceutical and/or dietetic liquid, solid (granulates, gums, tablets, capsules, bougies), hemi-solid, pressurised forms, ecc. Still according to the invention, said housings are provided in such a way that the packages of the single products are presented side- by-side, head by head, juxtaposed, or the shoulder opposed. Particularly, said side-by-side or head by head can be juxtaposed during their use. Preferably, it will be possible providing means, such as a strip of glue, protected by a removable coating, for fixing said housings juxtaposed. Always according to the invention, one or all said housings are provided with means for allowing the removal of price tag within the relevant packaged product, preferably a slit substantially realised in correspondence of the zone of the price tag on the product package, or lower resistance lines substantially realised in correspondence of the zone of the price tag on the product package. Further, according to the invention, said housings can be equal each other, or they can have different shape and dimensions. Still according to the invention, said package can be comprised of transparent or not transparent material. Preferably, according to the invention, said package can be comprised of each rigid, hemi-rigid, soft, elastic, ecc. material. Furthermore, according to the invention, said package can provide an opening to reach the packaged product, said opening being independent from the opening of the product package, and structurally and spatially co-ordinated with the opening of the product package, or it can be comprised of a tab foldable and fixable outside each single housing. Further, said package can be open in correspondence of the opening of the product package contained inside the same. Still according to the invention, it is possible providing instructions for using the package, said instructions being placed within a suitable pocket, or printed on the same package. The present invention will be now described, for illustrative but not limitative purposes, according to its preferred embodiments, with particular reference to the figures of the enclosed drawings, wherein: Figure 1 shows a perspective view of a first embodiment of the package according to the invention; Figure 2 shows a perspective view of a second embodiment of the package according to the invention; Figure 3 shows a perspective view of a third embodiment of the package according to the invention; Figure 4 is a bottom perspective view of the package of figure 2; Figures 5a - 5c show the steps for folding the package according to the invention shown in figure 2; Figure 6 is a bottom perspective view of a fourth embodiment of the package according to the invention; and Figures 7a - 7c show the steps for folding the package according to the invention shown in figure 6. Observing first figure 1 , it is shown a package according to the invention, indicated generically by reference number 1 , providing two housings 2, 3, each having an opening similar to the opening of a standard package for drugs. In embodiment of figure 1 , two housings are equal, realised for two equal packaged products, being it well evident that shape and dimensions of housings 2, 3 can be of any kind, this is not a feature limiting the present invention. Within package 1 , in each one of the two housings 2, 3, a package 4 is introduced (only one is shown in figure 1). The portion 5, so as to allow the contemporaneous selling of the two products, and consequently the coordinated consumption of the same products, couples two housings. A package 11 is shown in figure 2, provided as well with two housings 12, 13, for receiving two packaged products 14, and coupled by a part 15. In this case, the two housings 12, 13 are frontally opened to allow the direct insertion of the products 14. To reach what is contained within the packages, it will be sufficient opening the product 14 packages in a traditional way. In figure 3 it is shown a package 21 , provided with two housings 22, 23, for receiving two packaged products 24, said housings 22, 23 being coupled by a part 25. In this case, the two housings 12, 13 are frontally provided with a foldable limbo 26, having a tab 7, the end of which is coated with low adhesivity glue allowing closing and opening many times the package. Figure 4 is a bottom view of package 11. However, it must be noted that the features that will be illustrated can be provided also in the embodiments shown in the other figures. Particularly, it is provided a part 16, at the bottom of each one of the housings 12, 13, removable for allowing the removal of price tag. Further, at the bottom of one (12) of housings 12, 13, an adhesive strip 17 is provided, covered by a removable tab 18. Observing further figures 5a - 5c, it can be noted that, after having removed the tab 18, the two housings 12, 13, with the relevant products 14, can be folded, until reaching the configuration shown in figure 5c. Adhesive 17 will allow fixing this position. In this way, a configuration of the package 11 is obtained, allowing an easier use of the two products 14, with reduced dimensions. Further, being it possible modifying the configuration of the package afterwards, pharmacist has the possibility of removing the price tag from part 16. A solution analogous to the one described in the above is shown in figures 6 and 7a - 7c, with the sole difference that coupling between the two housings 12, 13 is obtained on the head side, and not laterally. The present invention has been described for illustrative but not limitative purposes, according to its preferred embodiments, but it is to be understood that modifications and/or changes can be introduced by those skilled in the art without departing from the relevant scope as defined in the enclosed claims.

Claims

1. Package for at least two different products, to be sold (and used) together, said package being characterised in that it provides at least one first housing for a first pre-packaged product and a second housing for a pre-packaged product, said first and second housing being coupled each other.

2. Package according to claim 1 , characterised in that said first and second housings provide a first and a second product for completing the particular therapeutical or nutritional cycle.

3. Package according to claim 1 o 2, characterised in that said products are liquid, solid, pharmaceutical and/or dietetic liquid, solid (granulates, gums, tablets, capsules, bougies), hemi-solid, pressurised forms, ecc.

4. Package according to claim 1 o 2, characterised in that said products are liquid, solid (granulates, gums, tablets, capsules, bougies) "nutritional products" hemi-solid, pressurised forms, ecc.

5. Package according to claim 1 o 2, characterised in that a statine chosen from the group comprising simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin or their derivatives or functional analogue, is inserted within the first housing, and one or more compounds chosen from the group comprising L-camitine and/or one or more alcanoil L-carnitine chosen from the group comprising acetyl L-camitine, propionyl L-carnitine, valeryl L-carnitine, isovaleryl L-carnitine o butyrril L-carnitine and/or coenzyme Q10 or its functional derivative is inserted within the second housing.

6. Package according to one of the preceding claims, characterised in that said housings are provided in such a way that the packages of the single products are presented side-by-side, head by head, juxtaposed, or the shoulder opposed.

7. Package according to claim 6, characterised in that said side- by-side or head by head can be juxtaposed, preferably during their use.

8. Package according to claim 7, characterised in that means are provided, such as a strip of glue, protected by a removable coating, for fixing said housings juxtaposed.

9. Package according to one of the preceding claims, characterised in that one or all said housings are provided with means for allowing the removal of price tag within the relevant packaged product.

10. Package according to claim 9, characterised in that a slit is provided substantially realised in correspondence of the zone of the price tag on the product package.

11. Package according to claim 9, characterised in that lower resistance lines are provided substantially realised in correspondence of the zone of the price tag on the product package.

12. Package according to one of the preceding claims, characterised in that said housings are equal each other.

13. Package according to one of the preceding claims 1 - 11 , characterised in that said housings have different shape and dimensions.

14. Package according to one of the preceding claims, characterised in that said package is comprised of transparent or not transparent material.

15. Package according to one of the preceding claims, characterised in that said package is comprised of each rigid, hemi-rigid, soft, elastic, ecc. material.

16. Package according to one of the preceding claims, characterised in that said package provides an opening to reach the packaged product.

17. Package according to claim 16, characterised in that said opening is independent from the opening of the product package.

18. Package according to claim 16, characterised in that said opening is structurally and spatially co-ordinated with the opening of the product package.

19. Package according to claim 16, characterised in that said opening is comprised of a tab foldable and fixable outside each single housing.

20. Package according to one of the preceding claims 1 - 15, characterised in that said package is open in correspondence of the opening of the product package contained inside the same.

21. Package according to one of the preceding claims, characterised in that instructions are provided for using the package.

22. Package according to claim 21 , characterised in that said instructions are placed within a suitable pocket.

23. Package according to claim 21, characterised in that said instructions are printed on the same package.

24. Package for at least two different products according to each one of the preceding claims, substantially as illustrated and described.