Advances and Opportunities in Delivery of Therapeutic Proteins and Peptides

Adjei, A. and P. Gupta . 1994. "Pulmonary Delivery of Therapeutic Peptides and Proteins," J. Cont. Rel., 29:361-373.

Akers, M. J. and S. L. Nail . 1994. "Top 10 Current Technical Issues in Parenteral Science," Pharm. Technol., 18:26-36.

Albin, G. W. , T. A. Horbett and B. D. Ratner . 1985. "Glucose Sensitive Membranes for Controlled Delivery of Insulin: Insulin Transport Studies," J. Cont. Rel., 2:153-164.

Albin, G. W. , T. A. Horbett , S. R. Miller and N. L. Ricker . 1987. "Theoretical and Experimental Studies of Glucose Sensitive Membranes," J. Cont. Rel., 6:267-291.

Arakawa, T. , S. J. Prestrelski , W. C. Kenney and J. F. Carpenter . 1993. "Factors Affecting Short-Term and Long-Term Stabilities of Proteins," Adv. Drug Del. Rev., 10:1-28.

Ashford, M. and J. T. Fell . 1994. "Targeting Drugs to the Colon: Delivery Systems for Oral Administration," J. Drug Target., 2:241-257.

Aungst, B. J. 1994. "Site-Dependence and Structure-Effect Relationships for Alkylglycosides as Transmucosal Absorption Promoters for Insulin," Int. J. Pharm., 105:219-225.

Aungst, B. J. and N. J. Rogers . 1989. "Comparison of the Effects of Various Transmucosal Absorption Promoters on Buccal Insulin Delivery," Int. J. Pharm., 53:227-235.

Baldwin, P. A. , C. K. Klingbeil , C. J. Grimm and J. P. Longenecker . 1990. "The Effect of Sodium Tauro-24,25-Dihydrofusidate on the Nasal Absorption of Human Growth Hormone in Three Animal Models," Pharm. Res., 7:547-552.

Banerjee, P. S. , E. A. Hosny and J. R. Robinson . 1991. "Parental Delivery of Peptide and Protein Drugs," in Peptide and Protein Drug Delivery, V. H. L. Lee , ed., NY, Marcel Dekker, Inc., pp. 487-543.

Banga, A. K. and Y. W. Chien . 1988. "Systemic Delivery of Therapeutic Peptides and Proteins," Int. J. Pharm., 48:15-50.

Barry, B. W. 1991. "Lipid-Protein-Partitioning Theory of Skin Penetration Enhancement," J. Cont. Rel., 15:237-248.

Barry, B. W. 1987. "Mode of Action of Penetration Enhancers in Human Skin," J. Cont. Rel., 6:85-97.

Bausch, A. and H. Leuenberger . 1994. "Wet Spherical Agglomeration of Proteins as a New Method to Prepare Parenteral Fast Soluble Dosage Forms," Int. J. Pharm., 101:63-70.

Benita, S. and M. Y. Levy . 1993. "Submicron Emulsions as Colloidal Drug Carriers for Intravenous Administration-Comprehensive Physicochemical Characterization," J. Pharm. Sci., 82:1069-1079.

Bergers, J. J. , W. D. Otter , H. F. J. Dullens , C. T. M. Kervliet and D. J. A. Crommelin . 1993. "Interleukin-2-Containing Liposomes: Interaction of Interleukin-2 with Liposomal Bilayers and Preliminary Studies on Application in Cancer Vaccines," Pharm. Res., 10:1715-1721.

Bhargava, H. N. , A. Narurkar and L. M. Lieb . 1987. "Using Microemulsions for Drug Delivery," Pharm. Technol., 11(3):46-54.

Biotechnology Medicines. 1993. Survey by Pharmaceutical Manufacturers Association, Washington, DC 20005.

Bommannan, D. , R. O. Potts and R. H. Guy . 1991. "Examination of the Effect of Ethanol on Human Stratum Corneum in vivo Using Infrared Spectroscopy," J. Cont. Rel., 16:299-304.

Buclin, T. , J. P. Randin , A. F. Jacquet , M. Azria , M. Attinger , F. Gomez and P. Burckhardt . 1987. "The Effect of Rectal and Nasal Administration of Salmon Calcitonin in Normal Subjects," Calcif. Tissue Int., 41:252-258.

Chiou, G. C. Y. 1991. "Systemic Delivery of Polypeptide Drugs through Ocular Route," Annu. Rev. Pharmacol. Toxicol., 31:457-467.

Chiou, G. C. Y. and C. Y. Chaung . 1988. "Treatment of Hypoglycemia with Glucagon Eye Drops," J. Ocular Pharmacol., 4:179-186.

Chiou, G. C. Y. , Z. F. Shen and H. P. Li Byron . 1992. "Effects of Permeation Enhancers BL-9 and Brij-78 on Absorption of Four Peptide Eyedrops in Rabbits," Acta Pharmacologica Sinica, 13:201-205.

Chiou, G. C. Y. , Z. F. Shen and Y. Q. Zheng . 1991. "Systemic Absorption of Oxytocin and Vasopressin through Eyes in Rabbits," J. Ocular Pharmacol., 7:351-358.

Chiou, G. C. Y. , Z. F. Shen and Y. Q. Zheng . 1990. "Adjustment of Blood Sugar Levels with Insulin and Glucagon Eyedrops in Normal and Diabetic Rabbits," J. Ocular Pharmacol., 6:233-241.

Chiou, G. C. Y. , Z. F. Shen , Y. Q. Zheng and Y. J. Chen . 1992. "Enhancement of Systemic Delivery of Peptide Drugs via Ocular Route with Surfactants," Drug Develop. Res., 27:177-183.

Damge, C. , C. Michel , M. Aprahamian and P. Couvreur . 1988. "New Approach for Oral Administration of Insulin with Polyalkylcyanoacrylate Nanocapsules as Drug Carrier," Diabetes, 37:346-351.

Davies, N. M. , S. J. Farr , J. Hadgraft and I. W. Kellaway , 1992. "Evaluation of Mucoadhesive Polymers in Ocular Drug Delivery. II. Polymer-Coated Vesicles," Pharm. Res., 9:1137-1144.

Duchene, F. , F. Touchard and N. A. Peppas . 1988. "Pharmaceutical and Medical Aspects of Bioadhesive Systems for Drug Administration," Drug Dev. Ind. Pharm., 14:283-318.

Elarini, S. K. and R. Tawaski . 1994. "Morphological and Fractal-Based Methods Describing Insulin Zinc Crystal Habits," Drug Dev. Ind. Pharm., 20:1-10.

Eppstein, D. A. and J. P. Longenecker . 1988. "Alternative Delivery Systems for Peptides and Proteins as Drugs," CRC Critical Reviews in Therapeutic Drug Carrier Systems, 5:99-139.

Evans, S. and P. Grassam . 1986. "Considerations for Parenteral Dosage Form Development of Natural Alpha Interferon," J. Parent. Sci. Technol., 40(3):83-87.

Garrison, M. D. , L. M. Doh , R. Q. Potts and W. Abraham . 1994. "Effect of Oleic Acid on Human Epidermis: Fluorescence Spectroscopic Investigation," J. Cont. Rel., 31:263-269.

Gazzaniga, A. , P. Iamartino , G. Maffione and M. E. Sangalli . 1994. "Oral Delayed-Release System for Colonic Specific Delivery," Int. J. Pharm., 108:77-83.

Greaves, J. L. and C. G. Wilson . 1993. "Treatment of Diseases of the Eye with Mucoadhesive Delivery Systems," Adv. Drug Del. Rev., 11:349-383.

Gursky, O. , J. Badger , Y. Li and L. D. Caspar . 1992. "Conformational Changes in Cubic Insulin Crystals in the pH Range 7-11," Biophys. J., 63:1210-1220.

Hanson, M. A. and S. K. E. Rowan . 1992. "Introduction to Formulation of Protein Pharmaceuticals," in Pharmaceutical Biotechnology, Vol. 3. Stability of Protein Pharmaceuticals: Part B: In vivo Pathways of Degradation and Strategies for Protein Stabilization, T. J. Ahern and M. C. Manning , eds., New York, NY, Plenum Press, pp. 209-233.

Hardy, J. G. , S. W. Lee and C. G. Wilson . 1985. "Intranasal Drug Delivery by Spray and Drops," J. Pharm. Pharmacol., 37:294-297.

Hartman, M. L. , A. Iranmanesh , M. O. Thorner and J. D. Veldhuis . 1993. "Evaluation of Pulsatile Patterns of Growth Hormone Release in Humans—A Brief Review," Amer. J. Hum. Biol., 5:603-614.

Hastewell, J. , S. Lynch , R. Fox , I. Williamson , P. Skelton-Stroud and M. Mackay . 1994. "Enhancement of Human Calcitonin Absorption across the Rat Colon in Vivo," Int. J. Pharm., 101:115-120.

Hayashi, M. 1993. "Strategies to Improve Intestinal Membrane Transport of Poorly Absorbed Drugs and Peptides," in Current Status on Targeted Drug Delivery to the Gastrointestinal Tract, Greenwood, SC, Capsugel Symposia Series, pp. 153-160.

Heller, J. 1993. "Modulated Release from Drug Delivery Devices," Crit. Rev. Ther. Drug Carr. Syst., 10:253-305.

Hochman, J. and P. Artursson . 1994. "Mechanisms of Absorption Enhancement and Tight Junction Regulation," J. Cont. Rel., 29:253-267.

Hopsu-Hava, V. K. , J. E. Fraki and M. Jarvinen . 1977. "Proteolytic Enzymes in the Skin," in Proteinases in Mammalian Cells and Tissues, North-Holland Biomedical Press, pp. 547-581.

Horbett, T. A. , B. D. Ratner , J. Kost and M. Singh . 1984. "A Bioresponsive Membrane for Insulin Delivery," in Rec. Adv. Drug Del. Sys., J. M. Anderson and S. W. Kim , eds., Plenum Publishing Corp., pp. 209-220.

Ishihara, K. , M. Kobayashi , N. Ishimaru and I. Shinohara . 1984. "Glucose Induced Permeation Control of Insulin through a Complex Membrane Consisting of Immobilized Glucose Oxidase and a Poly(amine)," Polymer J., 16:625-631.

Jaffe, H. A. , R. Buhl , A. Mastrangeli , K. J. Holroyd , C. Saltini , D. Czerski , H. S. Jaffe , S. Kramer , S. Sherwin and R. G. Crystal . 1991. "Organ Specific Cytokine Therapy: Local Activation of Mononuclear Phagocytes by Delivery of an Aerosol of Recombinant Interferon-Gamma to the Human Lung," J. Clin. Invest., 88:297-302.

Kim, S. , A. Kamada , T. Higuchi and T. Nishihata . 1983. "Effect of Enamine Derivatives on the Rectal Absorption of Insulin in Dogs and Rabbits," J. Pharm. Pharmacol., 35:100-103.

Kimura, H. , Y. Ogura , T. Moritera , Y. Honda , R. Wada , S. H. Hyon and Y. Ikada . 1992. "Injectable Microspheres with Controlled Drug Release for Glaucoma Filtering Surgery," Invest. Ophthalmol. Visual Sci., 33:3436-3441.

Koch, B. and B. Lutz-Bucher . 1985. "Specific Receptors for Vasopressin in the Pituitary Gland: Evidence for Down-Regulation and Desensitisation to Adrenocorticotropin-Releasing Factors," Endocrinology, 116:671-676.

Kost, J. 1993. "Ultrasound Induced Delivery of Peptides," J. Count. Rel., 24:247-255.

Kost, J. , T. A. Horbett , B. D. Ratner and M. Singh . 1985. "Glucose-Sensitive Membranes Containing Glucose Oxidase: Activity, Swelling and Permeability Studies," J. Biomed. Mat. Res., 19:1117-1133.

Kreuter, J. 1994. Nanoparticles in Colloidal Drug Delivery Systems, J. Kreuter , ed., New York, NY, Marcel Dekker, Inc., pp. 219-342.

Krishnamoorthy, R. and A. K. Mitra . 1993. "Ocular Delivery of Peptides and Proteins," in Ophthalmic Drug Delivery Systems, A. K. Mitra , ed., New York, NY, Marcel Dekker, Inc., pp. 455-469.

Lai, C. S. , C. E. Wolff , D. Novello , L. Griffone , C. Cuniberti , F. Molina and M. Rocco . 1993. "Solution Structure of Human Plasma Fibronectin under Different Solvent Conditions-Fluorescence Energy Transfer, Circular Dichroism and Light-Scattering Studies," J. Mol. Biol., 230:625-640.

Langer, R. , R. Siegel , L. Brown , K. Leong , J. Kost and E. Edelman . 1985. "Controlled Release and Magnetically Modulated Systems for Macromolecular Drugs," in Macromolecules as Drugs and as Carriers for Biologically Active Materials, D. A. Tirrell , L. G. Donaruma and A. B. Turek , eds., The New York Academy of Sciences, pp. 1-13.

Le Ray, A. M. , M. Vert , J. C. Gautier and J. P. Benoit . 1994. "Fate of (C-14) Poly(dl-lactide-co-glycolide) Nanoparticles after Intravenous and Oral Administration to Mice," Int. J. Pharm., 106:201-211.

Lee, V. H. L. 1988. "Peptide and Protein Drug Delivery Systems," BioPHARM, 1(3):24-31.

Lee, V. H. L. 1987. "Opthalmic Delivery of Peptides and Proteins," Pharm. Technol., 11(4):26-38.

Lee, V. H. L. , A. Yamamoto and U. B. Kompella . 1991. "Mucosal Penetration Enhancers for Facilitation of Peptide and Protein Drug Absorption," Crit. Rev. Ther. Drug Carr. Sysr., 8:91-192.

Lee, W. A. and J. P. Longenecker . 1988. "Intranasal Delivery of Proteins and Peptides," BioPHARM, 1(4):30-37.

Lee, W. A. , R. D. Ennis , J. P. Longnecker and P. Bengtsson . 1994. "The Bioavailability of Intranasal Salmon Calcitonin in Healthy Volunteers with and with-out a Permeation Enhancer," Pharm. Res., 11:747-750.

Lee, W. A. , B. A. Narog , T. W. Parapoff and Y. J. Wang . 1991. "Intranasal Bioavailability of Insulin Powder Formulations: Effect of Permeation Enhancer-to-Protein Ratio," J. Pharm. Sci., 80:725-729.

Leichter, S. B. , M. E. Schreiner , L. R. Reynolds and T. Bolick . 1985. "Long Term Follow Up of Diabetic Patients Using Insulin Infusion Pumps: Considerations for Future Clinical Application," Arch. Intern. Med., 145:1409-1412.

Li, B. H. P. and G. C. Y. Chiou . 1991. "Systemic Administration of Calcitonin through Ocular Route," Life Sci., 50:349-354.

Liu, F. , Z. Shao , D. O. Kildsig and A. K. Mitra . 1993. "Pulmonary Delivery of Free and Liposomal Insulin," Pharm. Res., 10:228-232.

Lowe, P. J. and C. S. Temple . 1994. "Calcitonin and Insulin in Isobutylcyanoacrylate Nanocapsules: Protection against Proteases and Effect on Intestinal Absorption in Rats," J. Pharm. Pharmacol., 46:547-552.

LueBen, H. L. , C. M. Lehr , C. O. Rentel , A. B. J. Noach , A. G. Deboer , J. C. Verhoef and H. E. Junginger . 1994. "Bioadhesive Polymers for the Peroral Delivery of Peptide Drugs," J. Cont. Rel., 29:329-338.

Machluf, M. and J. Kost . 1993. "Ultrasonically Enhanced Transdermal Drug Delivery-Experimental Approaches to Elucidate the Mechanism," J. Biomater. Sci. Polymer Edn., 5:147-156.

Manning, M. C. , K. Patel and R. T. Borchardt . 1989. "Stability of Protein Pharmaceuticals," Pharm. Res., 6:903-918.

McElvaney, N. G. , R. C. Hubbard , P. Birrer , M. S. Chernick , D. B. Caplan , M. M. Frank and R. G. Crystal . 1991. "Aerosol α1-Antitrypsin Treatment for Cystic Fibrosis," Lancet, 337:392-394.

Merkle, H. P. 1989. "Transdermal Delivery Systems," Meth. Find. Exp. Clin. Pharmacol., 11:135-153.

Michel, C. , M. Aprahamian , L. Defontaine , P. Couvreur and C. Damage . 1991. "The Effect of Site of Administration in the Gastrointestinal Tract on the Absorption of Insulin from Nanocapsules in Diabetic Rats," J. Pharm. Pharmacol., 43:1-5.

Middaugh, C. R. and D. B. Volkin . 1992. "Protein Solubility," in Pharmaceutical Biotechnology. Vol. 2. Stability of Protein Pharmaceuticals. Part A: Chemical and Physical Pathways of Protein Degradation, T. J. Ahern and M. C. Manning , eds., New York, NY, Plenum Press, pp. 109-134.

Morimoto, K. , H. Akatsuchi , K. Morisaka and A. Kamada . 1985. "Effects of Non-Ionic Surfactants in a Polyacrylic Acid Gel Base on the Rectal Absorption of (Asul, 7)-eel Calcitonin in Rats," J. Pharm. Pharmacol., 37:759-760.

Morita, T. , A. Yamamoto , Y. Takakura , M. Hashida and H. Sezaki . 1994. "Improvement of the Pulmonary Absorption of (Asu(1,7))-eel Calcitonin by Various Protease Inhibitors in Rats," Pharm. Res., 11:909-913.

Mrsny, R. J. 1991. "Challenges for the Oral Delivery of Proteins and Peptides: Theoretical and Practical Approaches to Their Delivery, Capsugel Symposia Series," Greenwood, SC, pp. 45-52.

Mrsny, R. J. , M. Cromwell , J. Villagran and W. Rubas . 1993. "Oral Delivery of Peptides to the Small Intestine," in Current Status on Target Drug Delivery to the Gastrointestinal Tract," Greenwood, SC, Capsugel Symposia Series, pp. 45-56.

Nishihata, T. , S. Kim , S. Morishita , A. Kamada , N. Yata and T. Higuchi . 1983a. "Adjuvant Effects of Glyceryl Esters of Acetoacetic Acid on Rectal Absorption of Insulin and Inulin in Rabbits," J. Pharm. Sci., 72:280-285.

Nishihata, T. , J. H. Rytting , A. Kamada , T. Higuchi , M. Routh and L. Caldwell . 1983b. "Enhancement of Rectal Absorption of Insulin Using Salicylates in Dogs," J. Pharm. Pharmacol., 35:148-151.

Nishihata, T. , Y. Okamura , A. Kamada , T. Higuchi , T. Yagi , R. Kawamori and M. Schichiri . 1985. "Enhancement Bioavailability of Insulin after Rectal Administration with Enamine as Adjuvant in Depancreatized Dogs," J. Pharm. Pharmacol., 37:22-26.

Niven, R. W. , F. D. Lott , A. Y. Ip and J. M. Cribbs . 1994. "Pulmonary Delivery of Powders and Solutions Containing Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF) to the Rabbit," Pharm. Res., 11:1101-1109.

Okada, H. , M. Yamamota , T. Heya , Y. Inoue , S. Kamei , Y. Ogawa and H. Toguchi . 1994. "Drug Delivery Using Biodegradable Microspheres," J. Cont. Rel., 28:121-129.

Oliyai, R. and V. J. Stella . 1993. "Prodrugs of Peptides and Proteins for Improved Formulation and Delivery," Annu. Rev. Pharmacol. Toxicol., 32:521-544.

Park, K. and J. R. Robinson . 1984. "Bioadhesive Polymers as Platforms for Oral-Controlled Drug Delivery: Method to Study Bioadhesion," Int. J. Pharm., 19:107-127.

Park, K. , S. L. Cooper and J. R. Robinson . 1987. "Bioadhesive Hydrogels," in Hydrogels in Medicine and Pharmacy. Vol. 3. Properties and Applications, N. A. Peppas , ed., FL, CRC Press, Inc., pp. 151-174.

Pillion, D. J. , D. L. McCracken , M. Yang and J. A. Atchison . 1992. "Glucagon Administration to the Rat via Eye Drops," J. Ocular Pharmacol., 8:349-358.

Ponchel, G. 1994. "Formation of Oral Mucosal Drug Delivery Systems for the Systemic Delivery of Bioactive Materials," Adv. Drug Del. Rev., 13:75-87.

Pontiroli, A. E. , A. Calderara and G. Pozza . 1989. "Intranasal Drug Delivery Potential Advantages and Limitations from a Clinical Pharmacokinetic Perspective," Clin. Pharmacokinet., 17:299-307.

Powell, M. F. 1994. "Peptide Stability in Aqueous Parenteral Formulations," in Formulation and Delivery of Proteins and Peptides, J. L. Cleland and R. Langer , eds., Washington, DC, American Chemical Society, pp. 100-117.

Pozzi, F. , P. Furlani , A. Gazzamiga , S. S. Davis and I. R. Wilding . 1994. "The Time Clock System: A New Oral Dosage Form for Fast and Complete Release of Drug after a Predetermined Lag Time," J. Cont. Rel., 31:99-108.

Radhakrishnan, R. , P. J. Milhalko and R. M. Abra . Jan. 23, 1990. "Method and Apparatus for Administering Dehydrated Liposomes by Inhalation," U.S. Patent 4,895,719.

Reddy, I. K. and A. K. Banga . 1993. "Biotechnology Drug Delivery: Oral vs Alternate Routes," Pharmacy Times, 59(11):92-98.

Rhode, B. H. and G. C. Y. Chiou . 1991. "Effects on Permeation Enhancers on Beta-Endorphin Systemic Uptake after Topical Application to the Eye," Ophthalmic Res., 23:265-271.

Rojanasakul, Y. , L. Wang , M. Bhat , D. D. Glover , C. J. Malanga and J. K. M. Ma . 1992. "The Transport Barrier of Epithelia: A Comparative Study on Membrane Permeability and Charge Selectivity in the Rabbit," Pharm. Res., 9:1029-1034.

Saffran, M. , C. Bedra , G. S. Kumar and D. C. Neckers . 1988. "Vasopressin: A Model for the Study of Effects of Additives on the Oral and Rectal Administration of Peptide Drugs," J. Pharm. Sci., 77:33-38.

Sanders, L. M. , J. S. Kent , G. I. McRae , B. H. Vickery , T. R. Tice and D. H. Lewis . 1984. "Controlled Release of a Luteinizing Hormone Releasing Hormone Analogue from Poly(D,L-lactide-co-glycolide) Microspheres," J. Pharm. Sci., 73:1294-1297.

Sanders, L. M. , G. McRae , K. Vitale , R. Burns , P. Hoffman and E. Shek . 1989. "Design and Performance of Controlled Release Biodegradable Delivery System of Nafarelin: An Overview," J. Pharm. Sci., 78:888-890.

Sanghvi, P. and U. V. Banakar . 1991. "Ultrasonics: Principles and Biomedical Applications," BioPHARM, 4:32-40.

Sarry, C. and H. Sucker . 1993. "Adsorption of Proteins on Microporous Membrane Filters: Part II," Pharm. Technol., 17(1):60-70.

Sarry, C. and H. Sucker . 1992. "Adsorption of Proteins on Microporous Membrane Filters: Part I," Pharm. Technol., 16(10):72-79.

Schaeffer, H. E. and D. L. Krohn . 1982. "Liposomes in Topical Drug Delivery," Invest. Ophthalmol. Vis. Sci., 22:222-227.

Shah, N. H. , A. S. Railkar , F. C. Chen , R. Tarantino , S. Kumar and A. W. Malick . 1993. "A Biodegradable Injectable Implant for Delivering Micromolecules and Macromolecules Using PLGA Copolymers," J. Cont. Rel., 27:139-147.

Shao, Z. H. , Y. P. Li , T. Chermak and A. K. Mitra . 1994. "Cyclodextrins as Mucosal Absorption Promoters of Insulin. II. Effects of Beta-Cyclodextrin Derivatives on Alpha-Chymotryptic Degeneration and Enteral Absorption of Insulin in Rats," Pharm. Res., 11:1174-1179.

Su, K. S. E. 1991. "Nasal Route of Peptide and Protein Drug Delivery," in Peptide and Protein Drug Delivery, V. H. L. Lee , ed., New York, NY, Marcel Dekker, Inc., pp. 595-631.

Su, K. S. E. 1986. "Intranasal Delivery of Peptides and Proteins," Pharm. Int., 7:8-11.

Tachibana, K. 1992. "Transdermal Delivery of Insulin to Alloxan-Diabetic Rabbits by Ultrasound Exposure," Pharm. Res., 9:952-954.

Takada, K. , Y. Nakahigashu , T. Tanaka , S. Kishimoto , Y. Ushirogawa and T. Takaya . 1994. "Pharmacological Activity of Tablets Containing Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF) in Rats," Int. J. Pharm., 101:89-96.

Takaya, T. , K. Niwa and K. Takada . 1994. "Pharmacological Effect of Recombinant Human Colony-Stimulating Factor (rhG-CSF) after Administration into Rat Large Intestine," Int. J. Pharm., 110:47-53.

Tice, T. R. and S. E. Tabibi . 1992. "Parental Drug Delivery: Injectables," in Treatise on Controlled Drug Delivery, A. Kydonieus , ed., New York, NY, Marcel Dekker, Inc., pp. 315-339.

Tojo, K. 1990. "Ophthalmic Drug Delivery by Prodrug Bioconversion," Drug News and Perspectives, 3:409-416.

Turco, S. 1994. "Devices," in Sterile Dosage Forms: Their Preparation and Clinical Application, PA, Lea & Febiger, pp. 318-343.

Tyle, P. Aug. 15, 1989. "Substained Release Growth Hormone Compositions for Parental Administration and Their Use," U.S. Patent 4,857,506.

Tyle, P. and P. Agrawala . 1989. "Drug Delivery by Phonophoresis," Pharm. Res., 6:355-361.

Vickery, B. H. 1991. "Biological Actions of Synthetic Analogs of Luteinizing Hormone-Releasing Hormone," in Pharmacokinetics and Pharmacodynamics. Vol. 3: Peptides, Peptoids and Proteins, P. D. Garzone , W. A. Colburn and M. Mokotoff , eds., Harvey Whitney Books Co., pp. 41-49.

Vilhardt, H. and P. Bie . 1983. "Antidiuretic Response in Conscious Dogs Following Peroral Administration of Arginine Vasopressin and Its Analogues," European J. Pharmacol., 93:201-204.

Walters, K. A. 1989. "Penetration Enhancers and Their Use in Transdermal Therapeutic Systems," in Transdermal Drug Delivery: Developmental Issues and Research Initiatives, J. Hadgraft and R. H. Guy , eds., New York, NY, Marcel Dekker, Inc., pp. 197-245.

Wang, Y. J. 1992. "Parenteral Products of Peptides and Proteins," in Pharmaceutical Dosage Forms: Parenteral Medications, K. E. Avis , H. A. Lieberman and L. Lachman , eds., New York, NY, Marcel Dekker, Inc., pp. 283-319.

Weiner, A. L. 1990a. "Lipid-Based Vehicles for Peptide and Protein Drugs: Part II: Manufacturing Variables," BioPHARM, 3(4):16-21.

Weiner, A. L. 1990b. "Developing Lipid-Based Vehicles for Peptide and Protein Drugs. Part I: Selection and Analysis Issues," BioPHARM, 3(3):27-32.

Weiner, A. L. 1989. "Liposomes as Carriers for Polypeptides," Adv. DrugDel. Rev., 3:307-341.

Wilding, I. R. , S. S. Davis , F. Pozzi , P. Furlani and A. Gazzaniga . 1994. "Enteric Coated Timed Release Systems for Colonic Targeting," Int. J. Pharm., 111:99-102.

Yasui, K. , H. Fujioka and Y. Nakamura . 1993. "Cryoprotective Effect of Gelatin and Albumin on Recombinant Human Tumor Necrosis Factor Liposome," Chem. Pharm. Bull., 41(12):2138-2140.

Yoshida, R. , K. Sakai , T. Okano and Y. Sakurai . 1993. "Pulsatile Drug Delivery Systems Using Hydrogels," Adv. Drug Del. Rev., 11:85-108.

Zaks, A. 1992. "Protein-Water Interactions: Role in Protein Structure and Stability," in Pharmaceutical Biotechnology, Vol. 2. Stability ofProtein Pharmaceuticals. Part A: Chemical and Physical Pathways of Protein Degradation, T. J. Ahern and M. C. Manning , eds., New York, NY, Plenum Press, pp. 249-271.

Zhou, X. H. 1994. "Overcoming Enzymatic and Absorption Barriers to Non-Parenterally Administered Protein and Peptide Drugs," J. Cont. Rel., 29:239-252.

Zhou, X. H. and A. L. W. Po . 1991. "Peptide and Proteins Drugs: II. Non-Parenteral Routes of Delivery," Int. J. Pharm., 75:117-130.