Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

The publications are arranged by topic, rather than by date in order provide a better overview of the collection.

Publications about Excipients
Publications about Dosage Forms
Publications about Packaging
Monographs for the Handbook of Excipients
All publications

Chris has additionally provided reviews and critiques of papers for Drug Development and Industrial Pharmacy, International Journal of Pharmaceutics, AAPS Pharm SciTech and Pharmaceutical Technology, as well as book reviews for Harcourt Press, Pharmaceutical Technology and Informa Healthcare.

Publications about Excipients

Wotton, P.K., Wade, G. and Moreton R.C., Excipients, in International Pharmaceutical Product Registration - Aspects of Quality, Safety and Efficacy, Cartwright, A.C. and Matthews, B.R. (Eds.), Ellis Horwood, London, UK, (1994), Chapter 5, 148 - 171.

Steele, D.F., Edge, S., Tobyn, M.J., Moreton, R.C. and Staniforth, J.N., Adsorption of an Amine Drug onto Microcrystalline Cellulose and Silicified Microcrystalline Cellulose Samples, Drug Dev. Ind. Pharm., (2003), 29, (4), 475 - 487.

Moreton, R.C., Excipient Interactions, in Excipient Development for Pharmaceutical, Biotechnology and Drug Delivery Systems, Katdare, A.V. and Chaubal, M.V. (Eds.), Informa Healthcare, New York, 2006, 93 - 108.

Moreton, R.C., Functionality and Performance of Excipients, Pharm. Technol., (2006) 30, (10 - Suppl), s4 – s14.

Moreton, R.C., New Excipients - From Idea to Market? American Pharmaceutical Review, (1998), 1, (1) 6 - 12.

Moreton, R.C., Aspects relating to Excipient Quality and Specifications, Pharm. Technol. Europe, (1999) 11, (12), 26 - 29.

Amidon, G.E., Peck, G.E., Block, L.H., Moreton, R.C., Katdare, A., Lafaver, R., and Sheehan, C., Proposed New USP General Information Chapter, Excipient Performance <1059>, Pharm. Forum, (2007), 33, (6), 1311 – 1323

Guazzaroni-Jacobs, M., Moreton, R.C. and Silverstein, I., Eye on Excipients, Tablets & Capsules, (2008), 6, (4), 45 – 50.

Steele, D,F., Moreton, R.C., Staniforth, J.N., Young, P.M., Tobyn, M.J., and Edge, S., Surface Energy of Microcrystalline Cellulose Determined by Capillary Intrusion and Inverse Gas Chromatography, AAPS Journal, (2008), 10, (3), 494 – 503.

Block, L.H., Moreton, R.C, Apte, S.P., Wendt, R.H., Munson, E.J., Creekmore, J.R., Persaud, I.V., Sheehan, C. and Wang, H., Co-Processed Excipients, Pharmacopeial Forum, (2009), 35, (4), July–Aug., 1026 – 1028.

Guazzaroni-Jacobs, M., Klug, D.B., Moreton, R.C. and Silverstein, I.B., Qualification of Excipients for use in Pharmaceuticals. Chimica Oggi (Chemistry Today), (2009), 27, (5), September/October, 6 – 8.

Moreton, R.C., Commonly used Excipients in Pharmaceutical Suspensions, in Pharmaceutical Suspensions: From Formulation Development to Manufacturing, Kulshreshtha, A.K., Singh, O.N. and Wall, G.M. (Eds.), Springer, New York, 2009, 67 – 102.

At the end of 2009 Chris was invited to write a regular column on Functionality and Performance of Excipients in a Quality-by-Design World which was published as a supplement in the 2010 November issue of American Pharmaceutical Review.

Moreton, R.C., Trends in Pharmaceutical Excipients: An Update, American Pharmaceutical Review, (2010), September/October, 22-27.

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Publications about Dosage Forms

Moreton, R.C. and Armstrong, N.A., Design and use of an apparatus for measuring diffusion through glycerogelatin films, Int. J. Pharm., (1995), 122, 79 - 89.

Moreton, R.C. and Armstrong, N.A., The effect of film composition on the diffusion of ethanol through soft gelatin films, Int. J. Pharm., (1998), 161, 123 - 131.

Collett, J.H. and Moreton, R.C., Modified Release Peroral Dosage Forms, in Pharmaceutics: The Science of Dosage Form Design, Aulton, M.E. (Ed.), Churchill Livingstone, London, UK, (2002), Chapter 20, 289 - 305 and (2007), Chapter 32, 483-499 and 3rd Ed., (2007), Chapter 32, 483 – 499

Moreton, R.C., Disintegrants in Tableting, in Pharmaceutical Dosage Forms: Tablets, Volume 2: Rational Design and Formulation, 3rd ed. Augsburger, L.L and Hoag, S.W. (Eds.), Informa Helathcare, New York, NY, (2008), Chapter 6, 217 - 249.

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Publications about Packaging

Barry, J, Bergum, J., Chen, Y., Chern, R., Hollander, R, Klein, D, Lockhart, H., Malinowski, D., McManus, R., Moreton, C., Mueller, A., Nottingham, L., Okeke, C., O’Reilly, D., Rinesmith, K., and Shorts, S., (PQRI Container-Closure Working Group), Basis for using Moisture Vapor Transmission Rate pre Unit Product in the evaluation of Moisture-Barrier Equivalence of Primary Packages for Solid Oral Dosage Forms, Pharmacopeial Forum, (2005), 31, (1) Jan - Feb., 226 - 269.

Monographs for the Handbook of Pharmaceutical Excipients

Chris has been actively involved with writing monographs for the Handbook of Pharmaceutical Excipients since 1993 and to date has contributed 10 monographs. He joined the International Steering Committee in 1999.

Moreton, R.C., Sugar Spheres, in The Handbook of Pharmaceutical Excipients, 2nd ed., Wade, A. and Weller, P.J. (Eds), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, (1994), 510 - 511.

Moreton, R.C., Hydrogenated Vegetable Oil, Type I, in The Handbook of Pharmaceutical Excipients, 2nd ed., Wade, A. and Weller, P.J. (Eds), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 1994, 544 - 545.

Moreton, R.C., Sugar Spheres, in The Handbook of Pharmaceutical Excipients, 3rd ed., Kibbe, A.H. (Ed.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2000, 548 - 549.

Moreton, R.C., Hydrogenated Vegetable Oil, Type I, in The Handbook of Pharmaceutical Excipients, 3rd ed., Kibbe, A.H. (Ed.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2000, 578 - 579.

Moreton, R.C., Dibasic Calcium Phosphate Dihydrate, in The Handbook of Pharmaceutical Excipients, 3rd ed., Kibbe, A.H. (Ed.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2000, 63 - 67.

Moreton, R.C., Dibasic Calcium Phosphate Anhydrous, in The Handbook of Pharmaceutical Excipients, 3rd ed., Kibbe, A.H. (Ed.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2000, 60 - 62.

Moreton, R.C., Calcium Sulfate, in The Handbook of Pharmaceutical Excipients, 3rd ed., Kibbe, A.H. (Ed.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2000, 73 - 76.

Moreton, R.C., Silicified Microcrystalline Cellulose, in The Handbook of Pharmaceutical Excipients, 3rd ed., Kibbe, A.H. (Ed.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2000, 110 - 111.

Moreton, R.C., Hydrogenated Vegetable Oil, Type I, in The Handbook of Pharmaceutical Excipients, 4th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2003, 669 - 671.

Moreton, R.C., Dibasic Calcium Phosphate Dihydrate, in The Handbook of Pharmaceutical Excipients, 4th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2003, 74 - 77.

Moreton, R.C., Dibasic Calcium Phosphate Anhydrous, in The Handbook of Pharmaceutical Excipients, 4th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2003, 72 - 73.

Moreton, R.C., Calcium Sulfate, in The Handbook of Pharmaceutical Excipients, 4th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2003, 83 - 85.

Moreton, R.C., Silicified Microcrystalline Cellulose, in The Handbook of Pharmaceutical Excipients, 4th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2003, 115 - 116.

Moreton, R.C., Sugar Spheres, in The Handbook of Pharmaceutical Excipients, 4th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2003, 630 - 631.

Moreton, R.C. and Owen, S.C., Olive Oil, in The Handbook of Pharmaceutical Excipients, 4th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2003, 414 - 416.

Moreton, R.C., Hydrogenated Vegetable Oil, Type I, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 800 - 801.

Moreton, R.C., Dibasic Calcium Phosphate Dihydrate, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 96 - 99.

Moreton, R.C., Dibasic Calcium Phosphate Anhydrous, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 93 - 95.

Moreton, R.C., Calcium Sulfate, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 105 - 107.

Moreton, R.C., Cellulose, Silicified Microcrystalline, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 139 - 141.

Moreton, R.C., Sugar Spheres, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 752 - 753.

Moreton, R.C. Olive Oil, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 498 - 416.

Moreton, R.C., Suppository Bases, Hard Fat, in The Handbook of Pharmaceutical Excipients, 5th ed., Rowe, R.C., Sheskey, P.J. and Weller, P.J. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2006, 762 - 766.

Moreton, R.C., Calcium Sulfate, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and Pharmaceutical Press, London, 2009, 105 - 107.

Moreton, R.C., Cellulose, Silicified Microcrystalline, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and Pharmaceutical Press, London, 2009, 139 - 141.

Moreton, R.C., Dibasic Calcium Phosphate Anhydrous, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and Pharmaceutical Press, London, 2009, 94 - 96.

Moreton, R.C., Dibasic Calcium Phosphate Dihydrate, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and Pharmaceutical Press, London, 2009, 96 - 99.

Moreton, R.C., Hydrogenated Vegetable Oil, Type I, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and Pharmaceutical Press, London, 2009, 762 - 763.

Moreton, R.C., Olive Oil, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2009, 470 - 472.

Moreton, R.C., Sodium Formaldehyde Sulfoxylate, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2009, 645 - 646.

Moreton, R.C., Sugar Spheres, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and Pharmaceutical Press, London, 2009, 712 - 714.

Moreton, R.C., Suppository Bases, Hard Fat, in The Handbook of Pharmaceutical Excipients, 6th ed., Rowe, R.C., Sheskey, P.J. and Quinn, M.E. (Eds.), American Pharmaceutical Association, Washington, and The Pharmaceutical Press, London, 2009, 722 - 726.

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