Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Aluminum – calcium or magnesium element – or compound containing
Reexamination Certificate
2000-11-15
2002-11-05
Pryor, Alton (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Aluminum, calcium or magnesium element, or compound containing
C424S693000, C514S724000, C514S738000
Reexamination Certificate
active
06475528
ABSTRACT:
The invention relates to a preparation composed of a fixed oil of vegetarian [sic] or animal origin, calcium hydroxide, a dihydric or polyhydric alcohol and, where appropriate, pharmaceutically acceptable excipients, to the preparation of a mixture of this type, to the use of a mixture of this type for collagen regeneration, and to the use of a mixture of this type for producing a medicine for promoting collagen regeneration in vivo.
Bone consists of about 60% mineral substance (hydroxyapatite, calcium phosphate) and about 40% organic material, principally collagen. Bone metabolism is determined mainly by the interplay of bone-constructing cells (osteoblasts) and bone-degrading cells (osteoclasts and osteocytes), whose activities in healthy bone are in a balanced relationship.
Bone formation can be divided into two main phases, (a) the synthesis of organic tissue (collagen synthesis) and (b) the deposition, which follows this and is mediated by so-called matrix vesicles, of mineral substance in the previously provided organic matrix.
The connective tissue protein collagen accounts for most of the organic substance in bone. The protein consists of three helically coiled polypeptide chains whose amino acid composition may vary, which leads to a diversity of individual types of collagen. It is common to all types of collagen that the collagen fibers have exceptionally great mechanical strength. This strength is based on a multiplicity of intra- and intermolecular linkages of the collagen fibers which, in this way, form the dense collagen fiber network of connective tissue. Bone tissue is—as already mentioned—formed by deposition of mineral substances (hydroxyapatite and calcium phosphate) in this network. Bone construction as a result of growth or regeneration processes is always preceded by collagen biosynthesis.
To date, in cases of bone injury of any cause, the bone regeneration process has been left to itself, at the most assisted by antibiotics and corticoids in order to prevent any risk of infection compromising the healing process.
Several factors able to influence bone formation and regeneration have also been described. These are mainly physical factors (mechanical and electrical forces), hormones (for example parathyroid hormone, calcitonin, insulin, glucocorticoids, 1,25-OHD3[sic]) and a not firmly defined group of growth factors with protein characteristics (osteochinin [sic], osteonectin, “insulin-like growth factors”)—cf. S. Wallach, L. V. Avioli, J. H. Carstens jun. “Factors in Bone Formation”, Calcified Tissue International 45: 4-6 (1989)). The effect of the hydrogen ion concentration (pH) on the metabolic processes in bone regeneration has not as yet been adequately investigated.
Dietz describes in DE-A-42 40 713 the use of a mixture of calcium hydroxide and neatsfoot oil for collagen regeneration following bone injuries. This preparation of calcium hydroxide and neatsfoot oil suffers, however, from the fact that its stability is very limited as a consequence of saponification. This may impair the effect of the mixture.
The invention was accordingly based on the object of indicating an improved mixture with long stability for the specific external influencing of the bone regeneration process through stimulation or initiation of collagen regeneration.
It has now surprisingly emerged that it is possible by using a preparation composed of calcium hydroxide, a dihydric or polyhydric alcohol and a fixed oil of vegetarian [sic] or animal origin and, where appropriate, pharmaceutically acceptable excipients to improve the stability of the preparation markedly and thus, on use of this preparation, in or for bone injuries, the extent of collagen regeneration in vivo is improved.
The present invention thus relates to preparations which comprise calcium hydroxide, a dihydric or polyhydric alcohol and a fixed oil of vegetarian [sic] or animal origin and, where appropriate, pharmaceutically acceptable excipients.
The present invention further relates to a process for producing a preparation of this type by means of mixing the calcium hydroxide and the dihydric or polyhydric alcohol and, where appropriate, pharmaceutically acceptable excipients into a fixed oil of vegetarian [sic] or animal origin.
The present invention further relates to the use of a preparation of this type for collagen regeneration.
The present invention further relates to the use of a preparation of this type for producing a medicine for promoting collagen regeneration in vivo.
Barium sulfate-containing mixtures of calcium hydroxide and neatsfoot oil have been used in dentistry as root-filling paste (DE-C 29 32 738). Mixtures of carboxylate cement, calcium hydroxide and neatsfoot oil have likewise been used in dentistry as temporary fixing means for provisional copings (DE-C 34 13 864). The task of the calcium hydroxide in the former case is to convert the acidic environment in the root canals into an alkaline one, resulting in the elimination of inflammations and gradual formation of a hard tissue barrier. In the latter case, the pulpitis-prophylactic effect of calcium hydroxide is utilized. The neatsfoot oil serves in both cases as a pasting auxiliary in order firstly to ensure simple and complete filling of the root canals with the actual active ingredient calcium hydroxide (and the contrast agent barium sulfate), and secondly to slow down the setting of the temporary fixing means for provisional copings so that the calcium hydroxide is also able to penetrate through the fine dentinal tubules to the pulp and display its effect there. Neither of the two references gives the slightest hint that the mixture according to the invention is able to induce extensive collagen regeneration as prerequisite for bone regeneration.
The term, which is novel according to the invention and is used hereinafter, “preparation” refers to a pharmaceutical preparation (sometimes also referred to as mixture hereinafter) which contains at least the abovementioned ingredients. It is particularly suitable for administration to humans or animals for research into collagen regeneration as prerequisite for bone regeneration.
The ingredients of the mixture according to the invention are described in more detail below:
The fixed oils of vegetarian [sic] origin which can be used may comprise one or more ingredients of the following vegetarian [sic] oils:
Soybean, sunflower, rape seed, cottonseed, linseed, castor, palm, palm kernel, coconut and olive oils.
The fixed vegetarian [sic] oils which can be used are preferably fixed vegetarian [sic] oils with high stability on heating, such as soybean, sunflower and olive oils, in particular olive oil.
The fixed animal oils which can be used may comprise one or more ingredients of the following animal oils:
Fish oils, animal foot oils and tallows.
The animal oils which can be used are preferably animal foot oils, in particular neatsfoot oil.
The dihydric or polyhydric alcohols which can be used may comprise dihydric alcohols such as ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol and polyethylene glycols such as diethylene glycol, triethylene glycol, polypropylene glycols such as dipropylene glycol, trihydric alcohols such as glycerol, tetrahydric alcohols such as threitol, erythritol, pentahydric alcohols such as arabitol, adonitol, xylitol, hexahydric alcohols such as sorbitol, mannitol, dulcitol, or higher polyhydric alcohols.
Preference is given to the use of dihydric and trihydric alcohols, such as ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol and polyethylene glycols such as diethylene glycol, triethylene glycol, polypropylene glycols such as dipropylene glycol, and trihydric alcohols such as glycerol, in particular glycerol as dihydric or polyhydric alcohol.
Without wishing to be bound to a theory, we assume that the dihydric or polyhydric alcohol prevents saponification of the vegetarian [sic] or ani
Breiner & Breiner L.L.C.
Pryor Alton
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