Excipients and Their Role in Approved Injectable Products: Current Usage and Future Directions | PDA Journal of Pharmaceutical Science and Technology

References

1.↵
1. Robertson M. I.
Regulatory issues with excipients. Int. J. Pharm. 1999, 187, 273–276.
OpenUrl PubMed Google Scholar
2.↵
1. Amidon G. E.,
2. Peck G. E.,
3. Block L. H.,
4. Moreton R. C.,
5. Katdare A.,
6. Lafaver R.,
7. Sheehan C.
〈1059〉 Excipient performance, a proposed new USP General Information Chapter. Pharmacopoeial Forum 2007, 33 (6), 1311–1321.
OpenUrl Google Scholar
3.↵
1. Moreton C.
Functionality and performance of excipients in a quality-by-design world: Part 1. Am. Pharm. Rev. 2009, 12 (1), 40–44.
OpenUrl Google Scholar
4.↵
Industry is developing a more profound understanding of excipients. Gold Sheet 2009, September.
Google Scholar
5.↵
BP. Parenteral Preparations. In British Pharmacopoeia, Stationary Office: London, 1999; Vol. II, p 1575.
OpenUrl Google Scholar
6.↵
EP. Parenteral Preparations. In European Pharmacopoeia, 6 ed.; Council of Europe: Strasbourg, 2009; p 1765.
Google Scholar
7.↵
1. Uchiyama M.
Regulatory status of excipients in Japan. Drug Information Journal 1999, 33 (1), 27–32.
OpenUrl Abstract/FREE Full Text Google Scholar
8.↵
1. Avis K. E.,
2. Lieberman H. A.,
3. Lachman L.
1. Boylan J. C.,
2. DeLuca P. P.
Formulation of Small Volume Parenterals. In Pharmaceutical Dosage Forms: Parenteral Medications, 2nd ed.; Avis K. E., Lieberman H. A., Lachman L. Eds. Marcel Dekker, Inc.: New York, 1992; Vol. 1, pp 173–248.
OpenUrl Google Scholar
9.↵
1. Matthews B.
Excipients used in products approved through the E.U. centralised procedure. The Regulatory Affairs J. 2002, 13 (12), 1036–1044.
OpenUrl Google Scholar
10.↵
1. Matthews B.
Excipients for non-oral routes of administration. The Regulatory Affairs J. 2002, 13 (11), 897–908.
OpenUrl Google Scholar
11.↵
1. Nema S.,
2. Washkuhn R. J.,
3. Brendel R. J.
Excipients and their use in injectable products. PDA J. Pharm. Sci. Technol. 1997, 51 (4), 166–171.
OpenUrl Abstract/FREE Full Text Google Scholar
12.↵
1. Powell M. F.,
2. Nguyen T.,
3. Baloian L.
Compendium of excipients for parenteral formulations. PDA J. Pharm. Sci. Technol. 1998, 52 (5), 236–311.
OpenUrl FREE Full Text Google Scholar
13.↵
1. Strickley R. G.
Parenteral formulations of small molecules therapeutics marketed in the United States (1999). Part I. PDA J. Pharm. Sci. Technol. 1999, 53 (6), 324–349.
OpenUrl FREE Full Text Google Scholar
14.↵
1. Strickley R. G.
Parenteral formulations of small molecules therapeutics marketed in the United States (1999). Part II. PDA J. Pharm. Sci. Technol. 2000, 54 (1), 69–96.
OpenUrl FREE Full Text Google Scholar
15.↵
1. Strickley R. G.
Parenteral formulations of small molecules therapeutics marketed in the United States (1999). Part III. PDA J. Pharm. Sci. Technol. 2000, 54 (2), 152–169.
OpenUrl FREE Full Text Google Scholar
16.↵
1. Wang Y. J.,
2. Hanson M. A.
Parenteral formulations of proteins and peptides: stability and stabilizers. PDA Pharm. J. Sci. Technol. 1988, 42 supplement, S4–S26.
OpenUrl Google Scholar
17.↵
1. Wang Y. J.,
2. Kowal R. R.
Review of excipients and pH's for parenteral products used in the United States. J. Parenter. Sci. Technol. 1980, 34 (6), 452.
OpenUrl Google Scholar
18.↵
GenRx. Mosby's GenRx, 8 ed.; Mosby-Year Book, Inc.: St. Louis, 1998.
Google Scholar
19.↵
Physician's Desk Reference, 63 ed.; Thomson Corporation: Toronto, 2009.
Google Scholar
20.↵
FDA. Inactive Ingredient Guide. In Division of Drug Information Resources; FDA, CDER: 2009.
Google Scholar
21.↵
1. Rowe R. C.,
2. Sheskey P. J.,
3. Quinn M. E.
Handbook of Pharmaceutical Excipients, 6 ed.; The Pharmaceutical Press: London, 2009.
Google Scholar
22.↵
1. Trissel L. A.
Handbook on Injectable Drugs, 10 ed.; American Society of Health-System Pharmacists, Inc: Bethesda, MD, 1998.
Google Scholar
23.↵
EMEA. Note for Guidance on Quality of Water for Pharmaceutical Use. In CPMP/QWP/158/01 revision—EMEA/CVMP/115/01 revision: May 2002.
Google Scholar
24.↵
EMEA. Reflection Paper on Water for Injection Prepared by Reverse Osmosis. In EMEA/CHMP/CVMP/QWP/28271/2008: 5 March 2008.
Google Scholar
25.↵
1. Sweetana S.,
2. Akers M. J.
Solubility principles and practices for parenteral drug dosage form development. PDA J. Pharm. Sci. Technol. 1996, 50 (5), 330–342.
OpenUrl FREE Full Text Google Scholar
26.↵
1. Yalkowsky S. H.,
2. Roseman T. J.
Solubilization of Drugs by Cosolvents. In Techniques of Solubilization of Drugs; Marcel Dekker, Inc.: New York, 1981; pp 91–134.
Google Scholar
27.↵
1. Hancock B. C.,
2. York P.,
3. Rowe R. C.
The use of solubility parameters in pharmaceutical dosage form design. Int. J. Pharm. 1997, 148, 1–21.
OpenUrl Google Scholar
28.↵
1. Rubino J. T.,
2. Yalkowsky S. H.
Cosolvency and cosolvent polarity. Pharm. Res. 1987, 4 (3), 220–230.
OpenUrl PubMed Google Scholar
29.↵
1. Brazeau G. A.,
2. Cooper B.,
3. Svetic K. A.,
4. Smith C. L.,
5. Gupta P.
Current perspectives on pain upon injection of drugs. J. Pharm. Sci. 1998, 87 (6), 667–677.
OpenUrl CrossRef PubMed Web of Science Google Scholar
30.↵
1. Brazeau G. A.,
2. Fung H.
Use of an in vivo model for the assessment of muscle damage from intramuscular injections: in vitro–in vivo correlation and predictability with mixed solvent systems. Pharm. Res. 1989, 6 (9), 766–771.
OpenUrl CrossRef PubMed Web of Science Google Scholar
31.↵
1. Reed K. W.,
2. Yalkowsky S.
Lysis of human red blood cells in the presence of various cosolvents. J. Parenter. Sci. Technol. 1985, 39 (2), 64–69.
OpenUrl PubMed Google Scholar
32.↵
1. Yalkowsky S. H.,
2. Krzyzaniak J. F.,
3. Ward G. H.
Formulation-related problems associated with intravenous drug delivery. J. Pharm. Sci. 1998, 87 (7) 787–796.
OpenUrl CrossRef PubMed Web of Science Google Scholar
33.↵
1. Mottu F.,
2. Laurent A.,
3. Rufenacht D. A.,
4. Doelker E.
Organic solvents for pharmaceutical parenterals and embolic liquids: a review of toxicity data. PDA J. Pharm. Sci. Technol. 2000, 54 (6), 456–465.
OpenUrl Abstract/FREE Full Text Google Scholar
34.↵
USP. 〈1〉 Injections. In USP, 32 ed.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2009.
Google Scholar
35.↵
JP. Injections. In The Japanese Pharmacopoeia, XV ed.; 2006, p 10.
Google Scholar
36.↵
1. Johnson D. M.,
2. Gu L. C.
Autoxidation and Antioxidants. In Encyclopedia of Pharmaceutical Technology; Swarbrick, J.; Boylan, J. C., Eds. Marcel Dekker, Inc.: New York, 1988; Vol. 1 , pp 415–449.
OpenUrl Google Scholar
37.↵
1. Pearlman R.,
2. Wang Y. J.
1. Herman A. C.,
2. Boone T. C.,
3. Lu H. S.
Characterization, Formulation, and Stability of Neupogen (Filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor. In Formulation, Characterization, and Stability of Protein Drugs: Case Histories; Pearlman R., Wang Y. J. Eds. Plenum Press: New York, 1996; Vol. 9, p 325.
OpenUrl Google Scholar
38.↵
1. Fatouros A.,
2. Osterberg T.,
3. Mikaelsson M.
Recombinant factor VIII SQ—influence of oxygen, metal ions, pH and ionic strength on its stability in aqueous solution. Int. J. Pharm. 1997, 155 (1), 121–131.
OpenUrl CrossRef Web of Science Google Scholar
39.↵
1. Stadtman E. R.
Metal ion-catalyzed oxidation of proteins: biochemical mechanism and biological consequences. Free Radical Biol. Med. 1990, 9 (4), 315–325.
OpenUrl CrossRef PubMed Web of Science Google Scholar
40.↵
1. Enever R. P.,
2. Po A. L. W.,
3. Shotton E.
Factors influencing decomposition rate of amitriptyline hydrochloride in aqueous solution. J. Pharm. Sci. 1977, 66 (8), 1087–1089.
OpenUrl PubMed Google Scholar
41.↵
1. Munson J. W.,
2. Hussain A.,
3. Bilous R.
Precautionary note for use of bisulfite in pharmaceutical formulations. J. Pharm. Sci. 1977, 66 (12), 1775–1776.
OpenUrl PubMed Google Scholar
42.↵
1. Akers M. J.
Antioxidants in pharmaceutical products. J. Parenter. Sci. Technol. 1982, 36 (5), 222–228.
OpenUrl PubMed Google Scholar
43.↵
Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products. In CPMP: January 1998.
Google Scholar
44.↵
EMEA. Guideline on Excipients in the Dossier for Application for Marketing Authorization of a Medical Product. In EMEA/CHMP/QWP/396951/2006: 19 June 2007.
Google Scholar
45.↵
1. Dabbah R.
The use of preservatives in compendial articles. Pharmacopeial Forum 1996, 22 (4), 2696.
OpenUrl Google Scholar
46.↵
Martindale: The Extra Pharmacopoeia. 31 ed.; Royal Pharmaceutical Society: London, 1996; p 1128.
Google Scholar
47.↵
British Pharmaceutical Codex, Royal Pharmaceutical Society: London, 1973. p 100.
Google Scholar
48.↵
1. Oishi S.
Effects of propyl paraben on the male reproductive system. Food Chem. Toxicol. 2002, 40 (12), 1807–1813.
OpenUrl CrossRef PubMed Web of Science Google Scholar
49.↵
1. Oishi S.
Effects of butylparaben on the male reproductive system in mice. Arch. Toxicol. 2002, 76 (7), 423–429.
OpenUrl CrossRef PubMed Web of Science Google Scholar
50.↵
1. Oishi S.
Lack of spermatotoxic effects of methyl and ethyl esters of p-hydroxybenzoic acid in rats. Food Chem. Toxicol. 2004, 42, 1845–1849.
OpenUrl CrossRef PubMed Web of Science Google Scholar
51.↵
1. Hoberman A. M.,
2. Schreur D. K.,
3. Leazar T.,
4. Daston D. P.,
5. Carthew P.,
6. Re T.,
7. Loretz L.,
8. Mann P.
Lack of effect of butylparaben and methylparabben on the reproductive system in male rats. Birth Defects Res. B Dev. Reprod. Toxicol. 2008, 83 (2), 123–133.
OpenUrl CrossRef PubMed Web of Science Google Scholar
52.↵
1. Dabbah R.
Harmonization of microbiological methods—a status report. Pharmacopeial Forum 1997, 23 (6), 5334–5344.
OpenUrl Google Scholar
53.↵
European Pharmacopoeia, 3 ed.; Council of Europe: Strasbourg, 1997; p 286.
Google Scholar
54.↵
USP. 〈51〉 Antimicrobial Effectiveness Testing. In USP, 32 ed.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2009.
Google Scholar
55.↵
CPMP. Note for Guidance on Maximum Shelf-life for Sterile Products for Human Use After First Opening or Following Reconstitution. CPMP, July 1998.
Google Scholar
56.↵
1. Lam X. M.,
2. Costantino H. R.,
3. Overcashier D. E.,
4. Nguyen T. H.,
5. Hsu C. C.
Replacing succinate with glycolate buffer improves the stability of lyophilized interferon-gamma. Int. J. Pharm. 1996, 142 (1), 85–95.
OpenUrl Google Scholar
57.↵
1. Piedmonte D. M.,
2. Summers C.,
3. McAuley A.,
4. Karamujic L.,
5. Ratnaswamy G.
Sorbitol crystallization can lead to protein aggregation in frozen protein formulations. Pharm. Res. 2007, 24 (1), 136–146.
OpenUrl PubMed Google Scholar
58.↵
1. Pikal M. J.
The Correlation of Structural Relaxation Time with Pharmaceutical Stability. Freeze-Drying of Pharmaceuticals and Biologicals Conference, Brownsville, VT, September 23–26, 1998.
Google Scholar
59.↵
1. Arakawa T.,
2. Kita Y.,
3. Carpenter J. F.
Protein-solvent interactions in pharmaceutical formulations. Pharm. Res. 1991, 8 (3), 285–291.
OpenUrl PubMed Google Scholar
60.↵
1. Miller D. P.,
2. Anderson R. E.,
3. de Pablo J. J.
Stabilization of lactate dehydrogenase following freeze-thawing and vacuum-drying in the presence of trehalose and borate. Pharm. Res. 1998, 15 (8), 1215–1221.
OpenUrl CrossRef PubMed Web of Science Google Scholar
61.↵
1. Carpenter J. F.,
2. Crowe J. H.
Modes of stabilization of a protein by organic solutes during desiccation. Cryobiology 1998, 25 (5), 459–470.
OpenUrl Google Scholar
62.↵
1. Baumann T. J.,
2. Smythe M. A.,
3. Kaufmann K.,
4. Miloboszewski Z.,
5. O'Malley J.,
6. Fudge R. P.
Dissolution times of adriamycin and adriamycin RDF. Am. J. Hosp. Pharm. 1988, 45, 1667.
OpenUrl Google Scholar
63.↵
1. Jain N. K.,
2. Jain S.,
3. Singhai A. K.
Enhanced solubilization and formulation of an aqueous injection of piroxicam. Pharmazie 1997, 52 (12), 942–946.
OpenUrl Google Scholar
64.↵
1. Meyer J. D.,
2. Manning M. C.
Hydrophobic ion pairing: altering the solubility properties of biomolecules. Pharm. Res. 1998, 15 (2), 188–192.
OpenUrl CrossRef PubMed Google Scholar
65.↵
1. Wang Y. J.,
2. Dahl T. C.,
3. Leesman G. D.,
4. Monkhouse D. C.
Optimization of autoclave cycles and selection of formulation for parenteral product. Part II: Effect of counter-ion on pH and stability of diatrizoic acid at autoclave temperatures. J. Parenter. Sci. Technol. 1984, 38 (2), 72–77.
OpenUrl PubMed Google Scholar
66.↵
JPE. Japanese Pharmaceutical Excipients Directory. Yakuji Nippo, Ltd: Tokyo, 2004.
Google Scholar
67.↵
Excipients in Pharmaceutical Dosage Forms: The Challenge of the 21st Century. Nice, France, May 14–15, 1998.
Google Scholar
68.↵
PF. Benzyl alcohol. Pharmacopeial Forum 1995, 21 (5).
Google Scholar
69.↵
USP. 〈1078〉 Good Manufacturing Practices for Bulk Pharmaceutical Excipients. In USP, 32nd ed.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2009.
Google Scholar
70.↵
Excipients in the Label and Package Leaflet of Medicinal Products for Human Use. In European Commission; July 2003; Guidelines Medicinal products for human use Safety, environment and information Vol. 3B.
Google Scholar
71.↵
CPMP. Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products. In CPMP/BWP/1793/02: 18 June 2003.
Google Scholar
72.↵
CPMP. Note for Guidance on Development Pharmaceutics. In CPMP: July 1998.
Google Scholar
73.↵
1. Akers M. J.
Excipient-drug interactions in parenteral formulations. J. Pharm. Sci. 2002, 91 (11), 2283–2300.
OpenUrl CrossRef PubMed Google Scholar
74.↵
1. Paul W. L.
Excipient intake and heavy metals limits. Pharmacopeial Forum 1995, 21 (6), 1638–1640.
OpenUrl Google Scholar
75.↵
Aluminum in large and small volume parenterals used in total parenteral nutrition. Federal Register 1998, 63 (2), 176–185.
OpenUrl PubMed Google Scholar
76.↵
FDA. Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Test for Human and Animal Parenteral Drugs. In Biological Products and Medical Devices, FDA: December 1987.
Google Scholar
77.↵
1. Opalchenova G. A.
Comparison of the microbial limit tests in the British, European, and United States Pharmacopeias and recommendation for harmonization. Pharmacopeial Forum 1994, 20 (4), 7872–7877.
OpenUrl Google Scholar
78.↵
1. Taylor P.
Regulation for excipients is brewing across the Atlantic. Pharm. Technol. 2009, 33 (2), 86–87.
OpenUrl Google Scholar
79.↵
Fatalities Associated with Ingestion of Diethylene Glycol-Contaminated Glycerin Used to Manufacture Acetaminophen Syrup—Haiti, November 1995–June 1996, In Morbidity and Mortality Weekly Report, U.S. Department of Health and Human Services: August 2, 1996; Vol. 45, pp 649–650.
OpenUrl PubMed Google Scholar
80.↵
FDA. Pharmaceutical Components at Risk for Melamine Contamination. U.S. Department of Health and Human Services, FDA.; August 2009.
Google Scholar
81.↵
FDA. Interim Inactive Ingredient Policy. Office of Generic Drugs (OGD), FDA, 1994.
Google Scholar
82.↵
1. Weiner M.,
2. Bernstein I. L.
Adverse Reactions to Drug Formulation Agents: A Handbook of Excipients, Marcel Dekker, Inc: New York, NY, 1989.
Google Scholar
83.↵
USP. 〈1074〉 Excipient Biological Safety Evaluation Guidelines. In USP, 32 ed.; U.S. Pharmacopeial Convention, Inc: Rockville, MD, 2009.
Google Scholar
84.↵
FDA. Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients. Guidance for Industry; FDA; May 2005.
Google Scholar
85.↵
1. Matthews B.
BSE/TSE risks associated with active pharmaceutical ingredients and starting materials: the situation in Europe and the global implications for healthcare manufacturers. PDA J. Pharm. Sci. Technol. 2001, 55 (5), 295–328.
OpenUrl FREE Full Text Google Scholar
86.↵
CPMP. Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products. In CPMP: 21 April 1999.
Google Scholar
87.↵
FDA. The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use. Guidance for Industry. U.S. Department of Health and Human Services, FDA: September 1997.
Google Scholar
88.↵
EMEA. Gelatin for Use in Pharmaceuticals: Explanatory Note. In EMEA/CPMP/4306/00/v0.2: 13 December 2000.
Google Scholar
89.↵
EMEA. First Cases of BSE in USA and Canada: Risk Assessment of Ruminate Materials Originating from USA and Canada. In EMEA/CHMP/BWP/27/04: 21 July 2004.
Google Scholar
90.↵
EMEA. CHMP Position Statement on Creutzfeldt-Jakob Disease and Plasma-Derived and Urine Derived Medicinal Products. In EMEA/CPMP/BWP/2879/02/rev 1: 23 June 2004.
Google Scholar
91.↵
1. Chuang V. T. G.,
2. Kragh-Hansen U.,
3. Otagiri M.
Pharmaceutical strategies utilizing recombinant human serum albumin. Pharm. Res. 2002, 19 (5).
Google Scholar
92.↵
CPMP. Position State on Polysorbate 80. In CPMP/BWP/1952/98: 22 October 1998.
Google Scholar
93.↵
1. Frank D. W.,
2. Gray J. E.,
3. Weaver R. N.
Cyclodextrin nephrosis in the rat. Am. J. Pathol. 1976, 83 (2) 367–382.
OpenUrl PubMed Web of Science Google Scholar
94.↵
1. Stella V. J.,
2. Rajewski R. A.
Cyclodextrins: their future in drug formulation and delivery. Pharm. Res. 1997, 14 (5), 556–567.
OpenUrl CrossRef PubMed Web of Science Google Scholar
95.↵
1. Thompson D. O.
Cyclodextrins—enabling excipients: their present and future use in pharmaceuticals. Crit. Rev. Ther. Drug Carrier Sys. 1997, 14 (1), 1–104.
OpenUrl PubMed Web of Science Google Scholar
96.↵
1. Loftsson T.,
2. Johannesson H. R.
The influence of cyclodextrins on the stability of cephalothin and aztreonam in aqueous solutions. Die Pharmazie 1994, 49, 292–293.
OpenUrl Google Scholar
97.↵
1. Lehner S. J.,
2. Muller B. W.,
3. Seydel J. K.
Effect of hydroxylpropyl-beta-cyclodextrin on the antimicrobial action of preservatives. J. Pharm. Pharmacol. 1994, 46 186–191.
OpenUrl PubMed Google Scholar
98.↵
1. Felt O.,
2. Buri P.,
3. Gurny R.
Chitosan: A unique polysaccharide for drug delivery. Drug Dev. Ind. Pharm. 1998, 24 (11), 979–993.
OpenUrl PubMed Google Scholar
99.↵
1. Jain R.,
2. Shah N. H.,
3. Malick A. W.,
4. Rhodes C. T.
Controlled drug delivery by biodegradable poly(ester) devices: different preparative approaches. Drug Dev. Ind. Pharm. 1998, 24 (8), 703–727.
OpenUrl PubMed Google Scholar
100.↵
1. Middleton J. C.,
2. Tipton A. J.
Synthetic biodegradable polymers as medical devices. Medical Plastics Biomaterials 1998, 5 (2) 30–39.
OpenUrl Google Scholar
101.↵
1. Pettit D. K.,
2. Lawter J. R.,
3. Huang W. J.,
4. Pankey S. C.,
5. Nightlinger N. S.,
6. Lynch D. H.,
7. Schuh J. A. C. L.,
8. Morrissey P. J.,
9. Gombotz W. R.
Characterization of poly(glycolide-co-D,L-lactide)/poly(D,L-lactide) microspheres for controlled release of GM-CSF. Pharm. Res. 1997, 14 (10), 1422–1430.
OpenUrl CrossRef PubMed Google Scholar
102.↵
1. Katre N. V.,
2. Asherman J.,
3. Schaefer H.
Multivesicular liposome (DepoFoam™) technology for the sustained delivery of Insulin-like Growth Factor—I. J. Pharm. Sci. 1998, 87 (11), 1341–1346.
OpenUrl PubMed Google Scholar
103.↵
1. Wang P.,
2. Johnston T. P.
Sustained-release Interleukin-2 following intramuscular injection in Rats. Int. J. Pharm. 1995, 113 (1), 73–81.
OpenUrl Google Scholar
104.↵
1. Moghimi S. M.
mechanisms regulating body distribution of nanospheres conditioned with pluronic and tetronic block co-polymers. Adv. Drug Deliv. Rev. 1995, 16 (2–3), 183–193.
OpenUrl Google Scholar
105.↵
1. Zheng J. Y.,
2. Bosch H. W.
Sterile filtration of NanoCrystal™ drug formulations. Drug Dev. Ind. Pharm. 1997, 23 (11), 1087–1093.
OpenUrl Google Scholar
106.↵
1. Knepp V. M.,
2. Muchnik A.,
3. Oldmark S.,
4. Kalashnikova L.
Stability of non-aqueous suspension formulations of plasma-derived factor IX and recombinant human alpha interferon at elevated temperatures. Pharm. Res. 1998, 15 (7), 1090–1095.
OpenUrl PubMed Google Scholar
107.↵
1. Sullivan S. A.,
2. Gilley R. M.,
3. Gibson J. W.,
4. Tipton A. J.
Delivery of taxol and other antineoplastic agents from a novel system based on sucrose acetate isobutyrate. Pharm. Res. 1997, 14 (11), 291.
OpenUrl Google Scholar
108.↵
1. Gombotz W. R.,
2. Pettit D. K.
Biodegradable polymers for proteins and peptide drug delivery. Bioconjug. Chem. 1995, 6 (4), 332–351.
OpenUrl CrossRef PubMed Web of Science Google Scholar
109.↵
1. Apte S. R.,
2. Ogwu S. O.
A review and classification of emerging excipients in parenteral medications. Pharm. Technol. 2003, 27 (3), 46–60.
OpenUrl Google Scholar