Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a flower or blossom
Reexamination Certificate
2000-11-13
2002-01-29
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a flower or blossom
C424S539000, C424S725000, C424S750000, C424S757000, C424S778000
Reexamination Certificate
active
06342255
ABSTRACT:
The present invention relates to pharmaceutical topical compositions containing pollen extracts and unsaponifiable fractions of vegetable oils for the treatment of cutaneous or circulatory pathologies on inflammatory, immune, proliferative or degenerative basis.
One of the problems of all cutaneous chronic inflammatory pathologies, when the etiological agent causing the inflammatory process itself cannot be removed, is the control of the inflammatory process and the reactivation of the tissue trophism. Chronic inflammatory processes are generally associated with severe dystrophism of the affected tissue, which is mainly related to the impairment of the efficiency of the tissue microcircle (permanent dilation of capillaries and venules with alterations of capillary permeability). When the inflammatory event is on an immunopathogenic basis, said process becomes chronic mainly as a consequence of a persistent alteration of the mutual regulation of the various components of the immune system and/or of cytochemical signals. On the other hand, each inflammatory process on immunopathogenic basis is expected to have a determined duration and naturally end when the exogenous noxae or the “non-self” elements which have triggered the immune process have been eliminated and the involved lymphocytes have undergone apoptosis death.
When the cause which has triggered the disease cannot be removed, the following therapeutical objectives should be attained:
1) control of the chronic inflammatory reaction by modulating self-regulation unbalances of the immune system, also through pharmacological stimulation of any poorly active immunocompetent cells;
2) direct reactivation of tissue trophism by acting on microcircle and on non-immunocompetent cells directly responsible for functionality and well-being of the tissue itself, which are generally involved in the damages related to the inflammatory reaction.
Said objectives are fundamental in case of both cutaneous and systemic, inflammatory pathologies. Therefore, a medicament exerting the above mentioned action on cutaneous pathologies could also be used in the case of systemic pathologies by means of a suitably formulated transdermal system. At present the available medicaments comprise steroidal or nonsteroidal, topical or systemic, immunosuppressors. On the other hand, the long-term topical and systemic side-effects of corticosteroids on tissue trophism are well known. Immunosuppressors such as cyclosporin have in their turn precise limits of use. Very few nonsteroidal anti-inflammatory drugs are useful to some extent in cutaneous chronic inflammatory pathologies, in that they are poorly active and induce pharmacological tolerance to the antiinflammatory action, even after short times. According to the available knowledge, wide-spectrum immunomodulators are known to induce no pharmacological tolerance to the antiinflammatory effect, while exerting a direct reactivation of cutaneous trophism, nor substances exerting a strong trophic effect in physiological conditions as well as an immunomodulating effect in pathological conditions, thanks to their vasoactive and vasogenic actions.
It has now unexpectedly been found that the combination of pollen extracts with vegetable oil unsaponifiables, administered topically, provides advantageous therapeutical results which are surprisingly resolutive in the treatment of the skin pathologies. This means that the topical formulations comprising said combination not only have a lenitive or symptomatic pharmacological activity, but also can cause, in a high number of cases, the even complete remission of the pathology, without relapses after the treatment has been interrupted.
The pollen extract is a complex mixture of natural substances and nutrients which has been used in the cosmetic art, thanks to its emollient and restitutive properties, in combination with other active principles having similar or complementary activity. Pollen extract is commercially available (see, for example, G. Proserpio, A. Malpede, A. M. Massera, Fitocosmetopea Sinerga, Sinerga Ed. 1995; CTFA Buyer's Guide) and it essentially comprises a mixture of protides (10-35%), glucides (15-40%), lipids (1-10%), salts, oligoelements, vitamins and a water content from 10 to 20%. It further contains a series of C
27
, C
26
and C
29
-sterols, as reported in Phytochemistry, 1968, Vol. 7, 1361-1365.
Pollen extract also has a series of further applications, generally related to the well-being of the body and of course depending on the type of extraction process as well as on the purity degree or concentration obtained.
In fact, being a natural nutrient, it is added to foodstuff intended for the improvement of psychophysical conditions in humans. For example, CN 1100599 describes a concentrate of pollen extracts for fighting fatigue and mental uneasiness. Similarly, KR 9400320, SU 1660668, EP 87669 disclose the alimentary use of pollen extracts in combination with other nutrients.
One widespread use of pollen extract is anyway in the cosmetic field, as active component with adjuvating action, generally in formulation with other active principles, excipients and carriers known in the art and useful for the intended purpose. Thus, for example, U.S. Pat. No. 4737360 discloses skin care compositions comprising a pollen extract and a blend of natural oils as carriers to increase skin permeability. Also JP 52090635, JP 6287106, RU 2054926, SU 1806736, SU 1785684, SU 1734751, SU 1713555, SU 1683750; SU 1597192, FR 2631824, FR 2597337, SU 992057 disclose formulations for the cosmetic use, mainly as face-creams, in which pollen extracts are mixed with a series of skin protective or nutritive components.
Pollen extracts are also used in the preparation of toilets soaps (SU 1691390, SU 1618759), tooth-pastes (SU 1007671), lipsticks (SU 1486167), hair-care compositions (RU 2072831, SU 997681).
It has also been described, albeit not very often, a potential use of pollen extract as a complement or supplement of pharmacological treatments in various allergic (EP 201053, JP 5076597), tumor (EP 220453, U.S. Pat. No. 5,744,187), infective (RU 2090198), inflammatory (FR 2142194, RO 80826, JP 9278665, CN 8603867) pathologies, as well as in other pharmaceutical applications (CH 381358, EP 499015, U.S. Pat. No. 3,906,092).
Conversely, no specific pharmacological properties or activities are known, ascribable to the unsaponifiable fraction obtainable from vegetable oils, such as olive, soybean, wheat germ, sunflower, avocado, sesame, almond, safflower, carrot seeds, peanut, hazelnut, castor oils and the like. Said oils are used per se in the alimentary field, as well as carriers, excipients, binders in topical cosmetic or pharmaceutical formulations, such as oils, gel, creams, pastes and the like.
The unsaponifiable fractions of said vegetable oils are a minimum percentage (0.5 to 3.5%) and substantially consist of mixtures of carotenoids, branched hydrocarbons, flavonoids, phytosterols and other products having a complex, still partially unknown structure.
Likewise, no combinations of pollen extracts with significant amounts of vegetable oil unsaponifiables, preferably of olive, soybean and wheat germ oils, are known, having pharmacological properties, in particular therapeutical activity on cutaneous or circulatory pathologies of various origin.
It has now unexpectedly been found that formulations comprising as active ingredient a combination of pollen extracts and vegetable oil unsaponifiables, optionally in combination with other active principles with adjuvating, complementary or supplementing activity, exert a potent, often resolutive therapeutical action in many different affections of the skin.
The formulations of the present invention, in particular those for the topical use, can unexpectedly modulate the vascularization of dermal tissues.
“Modulation of the vascularization” means the ability to restore the activity and efficiency of microcircle, when it has been impaired by conditions causing either its excessive (in chronic inflammatory conditions, psor
Codex V s.r.l.
Young & Thompson
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