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United States Patent (19) (11) 4,247,526 Jarvis Et Al

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United States Patent (19) (11) 4,247,526 Jarvis Et Al United States Patent (19) (11) 4,247,526 Jarvis et al. 45) Jan. 27, 1981 (54) METHOD FOR PRE PARING DICALCIUM Primary Examiner-O. R. Vertiz PHOSPHATE DHYDRATE WITH Assistant Examiner-Gregory A. Heller IMPROVED STABILITY Attorney, Agent, or Firm-S. M. Tarter; W. H. Duffey; (75) Inventors: William M. Jarvis, Webster Groves; F. D. Shearin Keun. Y. Kim, Clayton, both of Mo. 57 ABSTRACT (73) Assignee: Monsanto Company, St. Louis, Mo. Dicalcium phosphate dihydrate containing a sufficient amount of trimagnesium phosphate and/or tetrasodium 21) Appl. No.: 43,412 pyrophosphate to inhibit spontaneous hydrolysis and /or decomposition of the dicalcium phosphate dihy (22) Filed: May 29, 1979 drate is widely used as a dental polishing agent with and (51) int. Cl. ...................... COB 00/00; C01B 15/16; without added fluoride. Now it has been found that COB 25/26 dicalcium phosphate dihydrate containing a sufficient (52) U.S. C. .................................... 423/266; 423/267; amount of pyrophosphate to provide hydrolytic stabil 423/308; 423/311; 424/57 ity to the dicalcium phosphate can have improved fluo (58) Field of Search ............... 423/265, 266, 267, 307, ride stability when about 0.1 weight percent to about 5 423/308,309, 311, 313; 424/57 weight percent of trimagnesium phosphate, and about 0.1 weight percent to about 3 weight percent of at least (56) References Cited one pharmaceutically acceptable condensed phosphate U.S. PATENT DOCUMENTS salt is added to the formulation. In the preferred em 2,852,341 9/1958 Bell et al. .... 8 was 423/308 bodiment less than 2 percent sodium tripolyphosphate 3,012,852 12/1961 Nelson ................ a a 423/267 provides satisfactory results. 3,066,056 11/1962 Schlaeger et al. .. 423/267 3,464,786 9/1969 Harnisch et al. .................... 423/313 10 Claims, No Drawings 4,247,526 1. 2 (A) providing dicalcium phosphate dihydrate con METHOD FOR PREPARING DICALCUM taining a sufficient amount of pyrophosphate com PHOSPHATE DHYDRATE WITH IMPROVED plex to provide at least some hydrolytic stability to STABILITY the DCPD; 5 (B) adding to the dicalcium phosphate dihydrate BACKGROUND OF THE INVENTION from about 0.1 weight percent to about 5 weight The present invention relates to a method of prepar percent trimagnesium phosphate, based on the ing dentifrice abrasives, and more particularly to dical weight of the dicalcium phosphate dihydrate; and cium phosphate dihydrate with improved stability. (C) adding to the dicalcium phosphate dihydrate 10 from about 0.1 weight percent to about 3 weight Dicalcium orthophosphate dihydrate (CahPO4.2- percent of a pharmaceutically acceptable con H2O) that has been stabilized against spontaneous hy densed phosphate salt, based on the weight of the drolysis and/or decomposition with a small amount of dicalcium phosphate dihydrate. tetrasodium pyrophosphate in accordance with the The term "DCPD' as it is used in the specification processes such as those described by Moss et al in U.S. 15 and claims shall mean dicalcium phosphate dihydrate. Pat. No. 2,287,699 or with trimagnesium orthophos The term "pyrophosphate complex' shall mean the phate and the like has been utilized in dental prepara chemical composition that is formed when a salt of a tions for many years. Indeed, dicalcium phosphate dihy soluble pyrophosphate or calcium-alkali metal pyro drate frequently is stabilized against spontaneous hydro phosphate is added to DCPD during the precipitation lysis and/or decomposition with a small amount of both 20 stage to provide conventional hydrolytic stability to the tetrasodium pyrophosphate and trimagnesium phos DCPD. The term “hydrolytic stability” with respect to phate in dental preparations. DCPD shall mean DCPD that has been stabilized Furthermore, as is known to those skilled in the art, against spontaneous hydrolysis and/or decomposition. dentifrice formulations using dicalcium phosphate dihy DCPD containing the pyrophosphate complex can drate frequently contain sodium or potassium mono 25 be prepared by any number of techniques known to fluorophosphate as a source of fluoride ion to inhibit or those skilled in the art. Generally, a basic calcium-con retard the formation of dental caries. Thus, the use of taining material such as calcium carbonate, calcium dicalcium phosphate dihydrate with sodium or potas oxide, calcium hydroxide and mixtures thereof, includ sium monofluorophosphate and stabilized against spon ing mixtures commonly known as slaked lime, quick taneous hydrolysis and/or decomposition with tetraso 30 lime and hydrated lime, are added to dilute aqueous dium pyrophosphate and/or trimagnesium phosphate, solutions of orthophosphoric acid to precipitate DCPD. either with or without other polishing agents, are well Then, hydrolytic stability of the DCPD from the pyro known to those skilled in the art. phosphate complex is achieved by adding a calcium/- Although satisfactory results are obtained using the sodium pyrophosphate or a soluble pyrophosphate salt dental formulations as set forth above, it has been found 35 to the DCPD such as is disclosed in U.S. Pat. Nos. that over a period of time the soluble fluoride is lost 2,287,699; 3,012,852; 3,169,096; 3,411,873 and the like. from the dental formulations. For example, it has been In the preferred embodiment, the DCPD is prepared found that dental formulations containing dicalcium by adding 0.3 weight percent P2Os equivalent of tet phosphate dihydrate stabilized with tetrasodium pyro raalkali metal pyrophosphate to an aqueous mixture phosphate at up to 1 weight percent by weight P2O5, as containing DCPD having a pH from about 5.5 to about pyrophosphate, or about 2 weight percent trimagne 6.5 and then adding a sufficient amount of lime to the sium phosphate octahydrate, and sufficient sodium DCPD slurry to provide a pH from about 6.5 to about monofluorophosphate to provide about 1,000 parts per 8.0. million soluble fluoride will lose a substantial amount of The soluble pyrophosphate salts useful for preparing the soluble fluoride after prolonged storage. Only a 45 the pyrophosphate complex are well known to those small improvement is seen when both trimagnesium skilled in the art. Tetraalkali metal pyrophosphates such phosphate and tetrasodium pyrophosphate are used as tetrasodium pyrophosphate and tetrapotassium pyro together with respect to soluble fluoride stability. phosphate are preferred, and tetrasodium pyrophos Although Applicants do not wish to be bound by any phate is especially preferred to form the pyrophosphate particular theory, it is believed that the loss of soluble 50 complex. The amount of soluble pyrophosphate salt to fluoride in the formulation is related to the hydrolytic be added to the DCPD to provide partial hydrolytic instability of the dicalcium phosphate dihydrate. It is stability ranges from about 0.1 to about 5 percent by believed that fluoride ion catalyzes the formation of weight of P2O5, as pyrophosphate, based on the weight calcium hydroxyapatite which then reacts with the of the DCPD. It is preferred to add the soluble pyro soluble fluoride to form water-insoluble calcium 55 phosphate salt in an amount corresponding to an addi fluoroapatite and/or calcium fluoride. Hence, it can be tion of from about 0.5 to about 2.5 percent by weight of seen that improved fluoride stability of dicalcium phos P2O5, as pyrophosphate, based on the weight of the phate dihydrate may improve stability against spontane DCPD. On yet another basis, the soluble pyrophos ous hydrolysis and/or decomposition. phate salt is added in an amount which results in a In any event, it can be seen that there is a need for a DCPD containing from about 0.2 to about 2.5 percent method of preparing dicalcium phosphate dihydrate by weight of pyrophosphate P2O5, which would repre which will provide greater amounts of soluble fluoride sent typical stabilized DCPD. after prolonged storage. Now, a method to meet this After the DCPD containing the pyrophosphate com need is provided. plex is recovered from the slurry and dried, trimagne 65 sium phosphate is added by techniques known to the SUMMARY OF THE INVENTION art, as for example, blending powdered trimagnesium These and other needs are achieved by a method phosphate with the DCPD. The amount of trimagne which comprises: sium phosphate that can be used in the composition of 4,247,526 3 4 the present invention can vary within wide limits. The Pharmaceutically acceptable salts of a compound beneficial effects of the trimagnesium phosphate are having only one phosphorous atom, such as an ortho generally not observed at concentrations less than about phosphate, does not provide as much stability to the 0.1 weight percent, based on the weight of the DCPD, DCPD as provided by condensed phosphates, although and additional stability is not seen at concentrations 5 their presence in the DCPD prepared by the method of above about 5 weight percent, based on the weight of the present invention is not harmful. Indeed, it may be the DCPD. It is preferred to add between about 0.5 desirable to add such a compound along with the con weight percent and about 3 weight percent, based on densed phosphate to obtain maximum fluoride stability. the weight of the DCPD. The amount of the pharmaceutically acceptable con In addition, the trimagnesium phosphate used in the 10 densed phosphate salt can vary within wide limits. Al method of the present invention is generally added as though beneficial effects are observed at concentrations the octahydrate. However, other hydrates of magne as low as about 0.1 percent, based on the weight of the sium phosphate may be equivalent since the exact form DCPD, it is preferred to use higher concentrations, say of the effective magnesium phosphate after it has been greater than about 0.3 weight percent. There does not incorporated into a DCPD-based toothpaste formula- 15 seem to be a beneficial effect in using more than about tion is not known.
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