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McLellan AT, Luborsky L, Woody GE, O’Brien CP. “An improved diagnostic instrument for substance abuse patients.” The Addiction Severity Index. J Nery Ment Dis. 1980;168:26-33.

Montovan, S.M., et al. “The Effect of A Potent GnRH Agonist on Gonadal and Sexual Activity in the Horse”, Theriogenology, Jun. 1990, vol. 33 No. 6, pp. 1305-1321.

Mumford, E.L., “Use of Deslorelin Short-Term Implants to Induce Ovulation in Cycling Mares During Three Consecutive Estrous Cycles”, Animal Reproduction Science, vol. 39, 1995 pp. 129-140. Murray S, Wooltorton E. Alcohol-associated rapid release of alongacting opioid. CMAJ 2005;173(7):756.

Nally, J., et al., “Induction of Mucosal IgA Specific for SeMF3 for Streptococcus equi with Intranasal Vaccination Using a Sucrose Acetate Isobutyrate Based Delivery System”, Proceed. Int’l. Symp. Control. Rel. Bioact. Mater., 26 (1999) Controlled Release Society, Inc.

Nett, T.M., et al., “Further Studies on the Radioimmunoassay of Gonadotropin-releasing Hormone: Effect of Radioiodination, Antiserum and Unextracted Serum on Levels of Immunoreactivity in Serum”, Endocrinology vol. 101, No. 4, pp. 1135-1144, 1977. Reynolds, R.C., “Metabolism and pharmacokinetics of sucrose acetate Isobutyrate (SAIB) and sucrose octaisobutyrate (SOIB) in rats, dogs, monkeys or humans: a review, ” Food Chem. Toxicol. , 1998, 36 (2), pp. 95-99.

Reynolds, R.C. et al., “Sucrose acetate Isobutyrate (SAIB): historical aspects of its use in beverages and areview of toxicity studies prior to 1988,” Food Chem. Toxicol., 1998, 36 (2), pp. 81-93.

Sucrose Acetate Isobutyrate, 21 CFR 172.831 (1999).

Sullivan, et al., “Sustained Release of Orally Administered Active Using SABER Delivery System Incorporated into Soft Gelatin Capsules”, CRS Meeting, Jun. 1998, Las Vegas, NV.

Sullivan, J. J., et al., “Duration of Estrus and Ovulation Time in Nonlactating Mares Given Human Chorionic Gonadotropin During Three Successive Estrous Periods”, J.A.V.M.A., pp. 895-898, vol. 162, No. x, May 15, 1973.

Thompson, D. L., et al., “Effects of Melatonin and Thyrotropin Releasing Hormone on Mares During the Nonbreeding Season”, Journal ofAnimal Science, pp. 668-677, vol. 56, No. 3, 1983. Thompson, D. L., et al., “Testosterone Effects on Mares During Synchronization with Altrenogest: FHS, LH, Estrous Duration and Pregnancy Rate”, Journal of Animal Science, pp. 678-686, vol. 56, No.3, 1983.

Trescot AM, et al. “Opioid Guidelines in the Management of Chronic Non-Cancer Pain.” Pain Physician. 2006;9:1-40.

Vega-Rios A, Villalobos H, Mata-Segreda JF. “Acid-catalyzed hydrolysis of triacylglycerols obeys monoexponential kinetics.” Int J Chem Kinet. 1992;24:887-94.

Voss, J .L., et al., “The Effect of HCG on Duration of Oestrus, Ovulation Time and Fertility in Mares”, Journal of Reprod. Fert., Suppl. 23 (1975), 297-301.

Smith & Tipton (1996) “A Novel Parental Delivery System” AAPS Seattle, WA, Presentaion PDD 7270, 1996 Annual Meeting. Carraway, et al. (2000) “Drug Delivery From a Controlled Release Aerosol: Effects of Formulation Variables” AAPS J Abstract. Southern BioSystems, Inc. Birmingham AL, USA.

Carraway, et al. (2000) “Drug Release from a Novel Controlled Release Aerosol Based on Sucrose Acetate Isobutyrate” AAPS Midwest Regional Meeting Chicago, IL, May 22, 2000.

Darling, et al. (2000) “Extended Release of Human Growth Hormone Suspended in SABERTM Formulation Design and In Vitro Assessment” Genentech, Inc., South San Francisco, CA USA and Southern BioSystems, Inc. Birmingham AL, USA. Poster.

Gibson, et al. (1999) “Effects of FormulationVariables on Controlled Release of Paclitaxel and other Chemotherapeutic Agents from a Novel Delivery System” AAPS New Orleans, LA. Southern BioSystems, Inc. Birmingham AL, USA.

Gibson, et al. (1999) “In Vitro and In Vivo Evaluation of a Novel In Situ-Forming Pareteral Delivery System” Meeting of Recent Advances in Drug Delivery Systems, Salt Lake City, UT. Southern BioSystems, Inc. Birmingham AL, USA.

Johnson, et al. (1999) “Biodegradable Delivery Systems for Estradiol: Comparison Between Poly(DL-Lactide) Microspheres and the Saber Delivery System” Proceed. Int’l Symp. Control. Rel. Bioact. Mater., 26, Controlled Release Society, Inc.

Nabors, et al. (1994) “Controlled Release of Diclofenac-Na from Cellulose Ester Microspheres” PDD Presentation 7481 at the 1994 Ninth Annual AAPS Meeting in San Diego, CA, Nov. 6-10, 1994. Okumu, et al. (2000) “Evaluation of SABERTM as a Local Delivery System for rhVEGF-Formulation Design and In Vitro Assessment” Genentech, Inc., South San Francisco, CA USA and Southern BioSystems, Inc. Birmingham AL, USA.

Okumu, et al. (2001) “Evaluation of SABERTM as a Local Delivery System for rhVEGF-Formulation Design and In Vitro Assessment” Genentech, Inc., South San Francisco, CA USA and Southern BioSystems, Inc. Birmingham AL, USA. Poster.

Sullivan, et al. (1997) “Delivery of Taxol® and other Antineoplastic Agents from a Novel System Based on Sucrose Acetate Isobutyrate” AAPS Boston, MA. Southern BioSystems, Inc. Birmingham AL, USA.

Sullivan, et al. (1998) “Sustained Release of Bupivacaine from the SABER TM Delivery System” AAPS, San Francisco, CA. Southern BioSystems, Inc. Birmingham AL, USA.

Sullivan, et al. (1998) “Sustained Release of Progesterone and Estradiol from the SABERTM Delivery System: In Vitro and In Vivo Release Rates” CRS Las Vegas, NV. Southern BioSystems, Inc. Birmingham AL, USA.

Sullivan, et al. (1999) “Sustained Release of Lysozyme from the SABER TM Delivery System” AAPS, New Orleans, LA. Southern BioSystems, Inc. Birmingham AL, USA.

Sullivan, et al. (2000) “Sustained Release of Bupivacaine from the SABER TM Delivery System” Proceed. Int’l Symp. Control. Rel. Bioact. Mater., 27, Controlled Release Society, Inc. Paris, France, Jul. 7-13, 2000.

Tipton (1999) “Peptide Delivery from an In Situ Gelling System Based on Sucrose Acetate Isobutyrate” AAPS J Abstract. Southern BioSystems, Inc. Birmingham AL, USA.

Tipton (2000) “In Situ Gelling Systems” Sustained-Release Injectable Products, Ed. Senior & Radomsky, Interpharm Press, Denver, CO, pp. 258-259.

Tipton, et al. (2000) “Local Delivery from a Novel Biodegradable In Situ Delivery System” Sixth World Biomaterials Congress, Kamuela, HI, May 15-20, 2000. Southern BioSystems, Inc. Birmingham AL, USA.

* cited by examiner

Figure 1

Abuse Deterrance Study A8934
(Wt. % ratios SAIB/EL/IPM/CAB 381-20)
Ln Cum % = 0.0404(SAlB) + 0.0536(EL)+ 0.0922(lPM) - 0.159(CAB 171-15)

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R SQ=0.75 6000 +256-62-O2 (71/26/0/3) --I-256-32-04 (66/31/0/3) 50.00 ;@ 256452-06 (70/26/0/4) 8 g 40.00 2 '~ » 256-62-08 (65/31/O/4) Q) .2 '2 30-00 ' +256-62-1O(68/26/31’3) 5 Q 2000 . ‘ +256-62-12(63./31/3/3) --1---256-62-14 (67/26/3/4) 10.00 —256-62-1 6 (62/31/3/4) 0.00 ~ 0 50 100 150 200 W.W,256_62_ Time (min) 21 ,22,23(66.5/28/5/1.5/3.5)

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[blocks in formation]
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+65:27:3:5 SAlB:EL:ll\/l:CAB, 12mg/g OC

-I-65:27:3.5:4.5 SAlB:EL:lM:CAB, 12mg/g OC
63:29:3:5 SAlB:EL:lM:CAB, 12mg/g OC

65:30:1 :4 SAlB:EL:ll\/l:CAB, 12mg/g OC

-él€—70:27:3 SAlB:EL:lM:CAB 171-15, 12mg/g OC

—O-0.3% NaCl in 65:27:35 SAlB:EL:lM:CAB 12mg/g OC

--'+--1°/O NaCl in 65:27:3:5 SAlB:EL:lM:CAB 12mg/g OC

—-3% NaCl in 65:27:3:5 SAlB:EL:lM:CAB 12mq/g OC

0 20 40 60 so 100 120 140 160 180

Time (min)

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Cumulative Release (°/6)

Figure 3

Abuse Deterrance Study A8983

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45.0 40.0 35.0 30.0 25.0 20.0 -O—X035l 4 15.0 -I-X03515 . . “"*"'X035l 6 if 0.0 0 20 40 60 80 100 120 140 160 180 200 Time (min)

X03514: SAIB/EL/IM/CAB 381-20 (65/27/3.5/4.5)
X03515: SAIB/EL/IM/CAB 381-20 (65/27/3/5)
X03516: SAIB/EL/IM/CAB 381-20 (63/29/3/5)
X03517: SAIB/EL/IM/CAB 381-20 (63/29/3.5/4.5)

(all contained 12 mg/ml Oxycodone base)

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0 20 40 60 80 100 120 140 160 180 200 Time (min)

X03511 : 59.3; 31.4; 1; 8.6 SAIB; EL; IM; CAB-381-2()BP 9mg/g OC
X03512 : 59.8; 31.4; 1; 7.8 SAIB; EL; IM; CAB-381-2()BP 9mg/g OC

X03713 = 71; 23; 1; 5 SAIB; EL; IM; CAB-381-2OBP 9mg/g OC

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