Rapidly soluble oral solid dosage forms, methods of making same, and compositions thereof
Patent 5762961 Issued on June 9, 1998. Estimated Expiration Date: February 9, 2016. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
424/464, Tablets, lozenges, or pills424/465, With claimed perfecting feature in contents (e.g., excipient, lubricant, etc.)424/468, Sustained or differential release type424/489Particulate form (e.g., powders, granules, beads, microcapsules, and pellets)
The invention provides methods of making rapidly soluble tablets of decreased weight compared to similar solid tablets. The invention further provides novel, rapidly soluble tablets of decreased weight compared to similar solid tablets. The tablets offer increased rates of dissolution and disintegration.
Other References
Dialog.RTM. English Abstract of JP 58-216695 (Dec. 16, 1983)
Dialog.RTM. WPI File 351 Abstract of PCT WO 87/05300 (Sep. 11, 1987)
Sakurai, Y (ed.), "Food General Dictionary" Sixth Edition (The English translation is 10 pages total.)
Kanna et al., "Denaturation of Fish Muscle Protein by Dehydration-V." Bull. Tokai Reg. Fish. Res. Lab. (1974) 77:1-14
Reasons for Opposition, (1995) 5 pages total
Supplement of Reasons for Opposition (Dec. 31, 1995), 23 pages total
Grounds for Rejection, (1995) 6 pages total
Handbook of Natural Materials for Food Processing, Ninth Edition (Translation to be disclosed at a later date)
Chemical Dictionary, 7th Edition (Translation to be disclosed at a later date)
Stability and characterization of protein and peptide drugs, Wang et al. (eds.), 1993, table of contents enclosed herewith
Pogany et al., "A new approach to the theory of tabletting" Acta Pharm. Hung. (1988) 58:49-55
Hiestand et al., "Physical processes of tableting" J. Pharm. Sci. (1977) 66:510-519
Cooper et al., "Tableting research and technology" J. Pharm. Sci. (1972) 61:1511-1555
Rudnic et al., "Oral solid doseage forms" Chapter 92, Remington: The Science and Practice of Pharmacy, Nineteenth Edition, Gennaro Ed. (1995) Mack Publishing Company, Pennsylvania vol. II, pp. 1615-1649
Niwa et al., "Preparation of agglomerated crystals for direct tabletting and microencapsulation by the spherical crystallization technique with a continuous system" Pharm. Res. (1994) 11:478-484
Franz et al., "Cost evaluation of alternative pharmaceutical tableting processes by simulation" J. Pharm. Sci. (1980) 69:621-628
Lipps et al., "Characterization of wet granulation process parameters using response surface methodology. 1. Top-spray fluidized bed" J. Pharm. Sci. (1994) 83:937-947
Drissi-Alami et al., "The effects of the tabletting machine speed on physical characteristics of pharmaceutical powers" J. Pharm. Belg. (1993) 48:43-52
Ishino et al., "Influence of tabletting speed on compactibility and compressibility of two direct compressible powders under high speed compression" Chem. Pharm. Bull. (1990) 38:1987-1992
Sendall et al., "A study of powder adhesion to metal surfaces during compression of effervescent pharmaceutical tablets" J. Pharm. Pharmacol. (1986) 38:489-493
Jetzer, "Measurement of hardness and strength of tablets and their relation to compaction performance of powders" J. Pharm. Pharmacol. (1986) 38:254-258
Reading et al., "The effects of binder film characteristics on granule and tablet properties" J. Pharm. Pharmacol. (198) 36:421-426
Paronen et al., "Compressional characteristics of four starches" J. Pharm. Pharmacol. (1983) 35:627-635
Nakagawa, "Effects of tableting procedures on the preferred orientation of crystalline particles" Chem. Pharm. Bull. (1982) 30:1401-1407
Elsabbagh et al., "Physical properties and dissolution profiles of acetaminophen and acetylsalicyclic acid tables made from sucrosebased vehicles" Pharmazie (1981) 36:488-492
Naito et al., "Prediction of tableting problems such as capping and sticking: Theoretical calculations" J. Pharm. Sci. (1977) 66:254-259
Healey et al., "The mechanical properties of some binders used in tableting" J. Pharm. Pharmac. (1974) 26 Suppl:41P-46P
York et al., "The effect of temperature on the mechanical properties of some pharmaceutical powders in relation to tableting" J. Pharm. Pharmac. (1972) 24 Suppl:47P-56P
Sebhatu et al. "Effect of moisture sorption on tabletting characteristics of spray dried (15% amorphous) lactose" Pharm. Res. (1994) 11:1233-1238
Vromans et al., "Studies on tabletting properties of lactose. Part 1. The effect of intial particle size on binding properties and dehydration characteristics of lactose" Acta Pharm. Suec. (1985) 22:163-172
Vromans et al., "Studies on tableting properties of lactose. Part 2. Consolidation and compaction of different types of crystalline lactose" Pharm. Weekbl Sci! (1985) 7:186-193
De Boer et al., "Studies on tableting properties of lactose. Part III. The consolidation behaviour of sieve fractions of crystalline -lactose monohydrate" Pharm Weekbl Sci! (1986) 8:145-150
Van Kamp et al., "Studies on tableting properties of lactose. V. Effects of both lubrication and addition of disintegrants on properties of tablets prepared from different types of crystalline lactose" Acta Pharm. Suec. (1986) 23:217-230
Vromans et al., "Studies on tableting properties of lactose. VI. Consolidation and compaction of spray dried amorphous lactose" Acta Pharm. Suec. (1986) 23:231-240
Georgakopoulos et al., "The effects of using different grades of PVP and gelatin as binders in the fluidized bed granulation and tableting of lactose" Pharmazie (1983) 38:240-243
York et al., "Science Papers. The tensile strength and compression behaviour of lactose, four fatty acids, and their mixtures in relation to tableting" J. Pharm. Pharmac. (1973) 25:Suppl:1P-11P
Blakely et al., "Dry instant blood typing plate for bedside use" Lancet (1990) 336:854-855
Roser, "Trehalose, a new approach to premium dried foods" Trends in Food Sci. and Tech. (Jul. 1991) pp. 166-169
Colaco et al., "Trehalose stabilisation of biological molecules" Biotechnol. Internat. (1992) pp. 345-350
Roser, "Trehalose dyring: A novel replacement of freeze-drying" BioPharm. (1991) 4:47-53
Colaco et al., "Extraordinary stability of enzymes dried in trehalose: Simplified molecular biology" BioTech. (1992) 10:1007-1011
Roser et al., "A sweeter way to fresher food" New Scientist (May 1993) pp. 25-28
Madzarovova-Nohejlova, "Trehalase deficiency in a family" Gastroenterol. (1973) 65:130-13