Publications/Research

Publications | Key Presentations | Abstracts

Dr Luner’s publications span a wide range of subjects relevant to drug substance and drug product development. His work encompasses fundamental research, physical characterization methodology development and applied studies oriented toward gaining understanding of and addressing industrially relevant pharmaceutical development issues.

REFEREED JOURNAL PUBLICATIONS

A. Kalra, P.E. Luner, L.S. Taylor, S.R. Byrn, T. Li. Gaining thermodynamic insight from distinct glass formation kinetics of structurally similar organic compounds. J. Pharm. Sci. 107(1):192-202, 2018. link
K.Dave, P.E. Luner C. Forness, D. Baker, C. Jankovsky, and S. Chen. Feasibility of Focused Beam Reflectance Measurement (FBRM) to analyze pharmaceutical suspensions in preclinical development. AAPS PharmSciTech. (2017). link
C.M. Lee, P.E. Luner, K. Locke, K. Briggs. Application of an Artificial Stomach-Duodenum Reduced Gastric pH Dog Model for Formulation Principle Assessment and Mechanistic Performance Understanding. J. Pharm. Sci. 106 (8): 1987-1997, 2017. link
P.D. Jager, T. Bramante and P.E. Luner. Assessment of Pharmaceutical Powder Flowability using Shear Cell-Based Methods and Application of Jenike’s Methodology. J. Pharm. Sci. 104(11):3804-3813 (2015). link
P.E. Luner and J.J. Seyer. Assessement of crystallinity in processed sucrose by Near Infrared Spectroscopy and application to Lyophiles. J. Pharm. Sci. 103(9), 2884-2895, (2014) (Special issue dedicated to Prof. George Zografi). link
S. Mehrens, P.E. Luner. Application of Raman spectroscopy in establishing solid form integrity for a highly polymorphic API. Amer. Pharm. Rev.16(5):24-36 (2013). link
P.E. Luner. Solid form diversity of commonly used tableting excipients and its impact. Eur. Pharm. Rev. 18(3):53-63 (2013).
P.E. Luner, Y. Zhang, Y. Abramov and M.T. Carvajal. The impact of particle size reduction method on the surface properties of molecular crystals using Inverse Gas Chromatography. Crystal Growth and Design, 12(11): 5271-5282 (2012). link
Gift AD, Luner PE, Luedeman L, Taylor LS. Manipulating hydrate formation during high shear wet granulation using polymeric excipients. J. Pharm. Sci. 98 (12), 4670-4683 (2009).
Morris DG, Truitt BF, Kong, A, Leyva N, Luner PE. Influence of Formulation Composition and Processing on the Content Uniformity of Low-Dose Tablets Manufactured at Kilogram Scale. Pharm Dev Technol, 14 (5), 451 – 460 (2009). link
Gift AD, Luner PE, Luedeman L, Taylor LS. Influence of polymeric excipients on crystal hydrate formation kinetics in aqueous slurries. J. Pharm. Sci. 97 (12): 5198-5211 (2008).
Luner PE, Patel AD. Quantifying Crystal Form Content in Physical Mixtures of (±)-Tartaric Acid and (+)-Tartaric Acid Using Near Infrared Reflectance Spectroscopy. AAPS PharmSciTech. 2005; 06(02): E245-E252. link
Luner PE, Waterman KC; (USA). Assignee. 2004 20040420. Pharmaceutical compositions of atorvastatin. Application: US. US patent 2004-828398.
M.P. Seiler, P. Luner, T.O. Moninger, P.H. Karp, S. Keshavjee and J. Zabner. Thixotropic solutions enhance viral-mediated gene transfer to airway epithelia. American Journal of Respiratory Cell & Molecular Biology 27: 133-140 (2002).
P.E. Luner, A.D. Patel and D.C. Swenson. (+/-)-tartaric acid. Acta Crystallographica – Section C – Crystal Structure Communications 58: O333-O335 (2002). link
J. J. Seyer, P. E. Luner. Determination of crystallinity in the presence of excipients using diffuse reflectance near-infrared spectroscopy. Pharm. Dev. Tech. 6(4):1-10 (2001).
P.E. Luner and E. Oh. Characterization of the surface free energy of cellulose ether films. Colloids and Surfaces A: Physicochemical and Engineering Aspects. 181(1-2):31-48 (2001). link
A.D. Patel, P.E. Luner and M.S. Kemper. Low level determination of polymorph composition in binary powder mixtures using NIRS. J. Pharm. Sci. 90(3):360-370, (2001).
P. E. Luner and D. VanDer Kamp. Wetting characteristics of media emulating gastric fluids. Int. J. Pharm. 212 (1):81-91 (2001).
P. E. Luner and D. VanDer Kamp. Wetting behavior of bile salt-lipid dispersions and dissolution media patterned after intestinal fluids. J. Pharm. Sci. 90 (3):348-359 (2001).
P. E. Luner, L. E. Kirsch, S. Majuru, E. Oh, A.B. Joshi, D.E. Wurster and M.P. Redmon. Preformulation Studies on the s-isomer of oxybutynin hydrochloride, an improved chemical entity (ICETM). Drug Devel. Indust. Pharm. 27 (4):318-326 (2001).
L.E. Kirsch, X. Zhang, W. Muangsiri, M.P. Redmon, P.E. Luner, D.E. Wurster. Development of a lyophilized formulation for (R,R)-Formoterol (L)-Tartrate. Drug Devel. Indust. Pharm. 27 (1):89-96 (2001).
A.D. Patel, P. E. Luner, and M. S. Kemper. Quantification of mixtures of polymorphs in binary and multi-component mixtures using near infrared diffuse reflectance spectroscopy. Int. J. Pharm. 206 (1-2):63-74 (2000).
J. J. Seyer, P. E. Luner, and M. S. Kemper. Application of diffuse reflectance near-infrared spectroscopy for determination of crystallinity. J. Pharm. Sci. 89 (10):1305-1316 (2000).
P.E. Luner. Wetting properties of bile salt solutions and dissolution media. J. Pharm. Sci. 89 (3):382-395 (2000).
P.E. Luner, S. Majuru, J.J. Seyer, M.S. Kemper. Quantifying crystalline form composition in binary powder mixtures using near-infrared reflectance spectroscopy. Pharm. Dev. Tech. 5(2):231-246 (2000).
E. Oh and P.E. Luner. Surface energetics of ethylcellulose films and the influence of plasticizers. Int. J. Pharm. 188 (2):203-219 (1999).
R.L. Brashear, D.R. Flanagan, P.E. Luner, J.J. Seyer, and M.S. Kemper. Diffuse reflectance near-infrared spectroscopy as a non-destructive analytical technique for polymer implants. J. Pharm. Sci. 88 (12):1348-1353 (1999).
P.E. Luner, S.R. Babu and S. Mehta. Wettability of a hydrophobic drug by surfactant solutions. Int. J. Pharm. 128:29-44 (1996).
P.E. Luner, S.R. Babu and G.W. Radebaugh. The effect of bile salts and lipids on the physicochemical behavior of gemfibrozil. Pharm. Res. 11:1755-1760 (1994).
P.E. Luner and G.L. Amidon. Description and simulation of a multiple mixing-tank model to predict the effect of bile sequestrants on bile salt excretion. J. Pharm. Sci. 82:311-318 (1993).
P.E. Luner, and G.L. Amidon. Equilibrium and kinetic factors influencing bile sequestrant efficacy. Pharm. Res. 9:670-676 (1992).

Publications | Key Presentations | Abstracts | Home

KEY PRESENTATIONS

“Understanding process induced phase transformation in solid dosage form development,” American Association of Pharmaceutical Scientists (AAPS) eLearning Webinar, April 2, 2015.
“The impact of excipient solid form diversity and variation on pharmaceutical manufacturing,” 11th Annual Garnet E. Peck Symposium, “Pharmaceutical Manufacturing and Regulatory Issues,” March 7, 2014. Purdue University, West Lafayette, IN.
“Solid Form Aspects of Excipients and their Influence on Formulation and Process,” 2012 NIPTE Research Conference on Excipients: Understanding Excipient Performance – Key to Successful QbD Formulation Design. June 13-14, 2012. FDA Conference Facilities White Oak, Silver Spring, MD. https://www.slideshare.net/boehringerus/nipte-2012
“Toward Understanding API Phase Transformations Due to Processing for Oral Solid Dosage Forms,” FDA ONDQA – CEDR, Oct. 26, 2006, Rockville, MD.
“Unit Operation Effects on API Properties,” 48th Annual Land O’Lakes International Industrial Pharmaceutical Research and Development Conference. June 5-9, 2006, Merrimac, Wisconsin
“Pharmaceutical Applications of Near Infrared Spectroscopy and its use as a Physical Characterization Method,” University of Michigan, College of Pharmacy, Jan 20, 2006, Ann Arbor, MI.
“Applications of Infrared Reflectance Spectroscopy in Solid-State Characterization,” Purdue University, School of Pharmacy and Pharmacal Sciences, May 17, 2005, West Lafayette, IN.
“Impact of particle size in tablet development,” Mettler Toledo Particle Size Matters Workshop on Milling, Granulation, Liquid Formulation and Tableting, Aug 25, 2005, Iselin, NJ.
“Surface Free Energy of Cellulose Ether Films,” 2^ndInternational Conference on Contact Angle, Wetting and Adhesion, K. Mittal, Organizer. Newark, NJ, June 21-23, 2000. (E. Oh, co-author).
“Wetting of pharmaceutical surfaces by bile salt and bile salt-lipid solutions,” 72nd American Chemical Society Colloid and Surface Science Symposium, Pennsylvania State University, June 21-24, 1998. (E. Oh and C.F. Freed, co-authors)

Publications | Key Presentations | Abstracts | Home

ABSTRACTS

K. Dave, C. Forness, D. Baker, C. Jankovsky, P. Luner, S. Chen. Use of Focused Beam Reflectance Measurement (FBRM) for Analysis of Pharmaceutical Suspensions. Poster presentation at the 2014 AAPS Annual Meeting and Exposition; November 2-6, San Diego, CA, Poster T3301.
P. Jager, T. Bramante, P. Luner. A quantitative assessment of powder flow in hoppers. AAPS Northeast Regional Discussion Group Meeting, Rocky Hill, CT, April 19, 2013.
Li Zhong, C. Jankovsky, C. Telang, P. Luner, and C. Bhugra. Practicality of stress testing in early amorphous drug development to select dispersion matrix composition. Poster presentation at the 2012 AAPS Annual Meeting and Exposition, October 14-17, Chicago, IL. Poster W5201.
P. Luner and J. Seyer. Crystallinity Determination of Intact Lyophilized Semi-Crystalline Cakes Using NIR Spectroscopy: Practical Lessons for Quantifying 1-State Systems. 13th International Workshop on Physical Characterization of Pharmaceutical Solids (IWPCPS-13, ASSA International), Barcelona, Spain, June 25-28, 2012.
K. Briggs, K. Locke, P. Luner, C-M. Lee. Development of an artificial stomach-duodenum system model (ASD). AAPS Northeast Regional Discussion Group Summer Conference, Merck Research Laboratories, Boston MA, September 2, 2011.
Y. Zhang, P. Luner and T. Carvajal. Impact of particle size reduction method on the surface properties of molecular crystals using Inverse Gas Chromatography Poster Presentation at the 2010 AAPS Annual Meeting and Exposition, November 14–18, 2010, New Orleans, LA. Poster T2138; PSWC2010-003699.pdf
P. Luner, Y. Zhang, T. Carvajal and Y. Abramov. The impact of particle size reduction method on the surface properties of molecular crystals using Inverse Gas Chromatography. 12th International Workshop on Physical Characterization of Pharmaceutical Solids (IWPCPS-12, ASSA International), Lille, France, June 21-24, 2010
P. Luner, A. Campeta, S. Mehrens, S. Sasic, H. Frericks-Schmidt, B. Chekal, P. Drupa, I. Saracovan. Impact of processing on a crystalline API: A case study in assessing disorder and potential implications in drug product. 12th International Workshop on Physical Characterization of Pharmaceutical Solids (ASSA International), Lille, France, June 21-24, 2010.
P.E. Luner, K. Sagawa. Assessment of the impact of crystal form on bioavailability using pharmacokinetic modeling. 10th International Workshop on Physical Characterization of Pharmaceutical Solids (ASSA International), Bamberg, Germany June 8 – 13, 2008.
I. Colon-Rivera, P. Luner, T. Shire. Application of Intrinsic Dissolution Analysis for Supporting Active Pharmaceutical Ingredient Particle Size Assessment. AAPS Annual Meeting, Nov 2008, The AAPS Journal Vol. 8, No. S2.
D. Morris, B.F. Truitt, Y. Yang, A. Kong, P. Luner. Laboratory-Scale Assessment of the Impact of Excipients and Processing Method on Low-dose Tablet Content Uniformity. AAPS Annual Meeting, Nov 2006, San Diego CA. The AAPS Journal Vol. 8, No. S2, Abstract T2227.
Hai Wang, Jan Soto, Jennifer Chu, Paul Luner, Thomas Vendola. Prediction of Amount of Granulating Liquid Using a Mixer Torque Rheometer: Correlation of Torque Profile with Granule Growth Behavior. AAPS Annual Meeting, Nashville, TN, 2005. The AAPS Journal Vol. 7, No. S2, Abstract W5250 (2005).
S. Sutton, M. amEnde, L. Appel, R. Beihn, J. Bennett, T. Boyden, B. Caldwell, M. Chidlaw, J. Cook, J. Crison, L. Evans, R. Gaskin, S. Herbig, S. LeMott, P. Luner, et al. Biopharmaceutical Properties that Impact the Successful Prediction of In Vivo Performance of Oral Dosage Forms. AAPS Annual Meeting, Nashville, TN, 2005. The AAPS Journal Vol. 7, No. S2, Abstract 270 (2005). Available from: http://abstracts.aaps.org/published/
T. Vendola, H. Wang, P. Luner, B. Truitt. An API sparing method to facilitate rapid development of a high drug loading wet granulated formulation- a case study. Annual Meeting of the American Association of Pharmaceutical Scientists (November, 2004, Baltimore, MD), Poster #W4146.
J.J. Seyer and P.E. Luner. Determination of crystallinity in lyophilized cakes using diffuse reflectance near-infrared spectroscopy. 17th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2002, Toronto, Canada), Poster #T2321.
M.S. Kemper, L.M. Luchetta, P.E. Luner, J.J. Seyer and A.D. Patel. Use of near-infrared reflectance spectroscopy as a rapid and facile means to characterize various crystalline forms of lactose raw material. 224th ACS National Meeting (August 18-22, 2002, Boston, MA) Div. Agricultural & Food Chemistry; Abstract # 534091.
A.D. Patel, D. Swenson, and P.E. Luner. Solid state characterization and crystal structure of dl-tartaric acid. 15th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2000, Indianapolis, IN), PharmSci 2(4): 3587.
M.S. Kemper, L.M. Luchetta, P.E. Luner, J.J. Seyer, A.D. Patel, W.J. McCarthy and E.J. Magnuson. Application of FT-NIR reflectance spectroscopy for the simultaneous quantification of multiple crystalline forms of lactose. 15th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2000, Indianapolis, IN), PharmSci 2(4): 3619.
D. VanDer Kamp and P.E. Luner. Wetting properties of biorelevant media. 15th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2000, Indianapolis, IN), PharmSci 2(4): 3322.
J.J. Seyer and P.E. Luner. Determination of crystallinity in processed sucrose using diffuse reflectance near-infrared spectroscopy and X-ray powder diffraction. 15th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2000, Indianapolis, IN), PharmSci 2(4): 3573
M.S. Kemper, P.E. Luner, J.J. Seyer, W.J. McCarthy. Use of Near-Infrared reflectance spectroscopy as a rapid means to characterize various crystalline forms of lactose for use in pharmaceutical products. Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, New Orleans, LA, March 12-17, 2000.
A.D. Patel, P.E. Luner and M.S. Kemper. Solid-state determination of the optical purity of tartaric acid using near infrared reflectance spectroscopy. 14th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1999, New Orleans, LA), PharmSci 1(4):S-189 (1999).
J.J. Seyer, P.E. Luner, M.S. Kemper. Comparison of diffuse reflectance near-infrared spectroscopy and X-ray powder diffraction for determination of crystallinity. 14th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1999, New Orleans, LA), PharmSci 1(4):S-188 (1999).
L. Kirsch, X. Zhang, W. Muangsiri, P. Luner, D Wurster, M. Redmon. Development of lyophilized RR-formoterol (L) tartrate. 14th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1999, New Orleans, LA), PharmSci 1(4):S-271 (1999).
L. Kirsch, S. Majuru, E. Oh, A. Joshi, P. Luner, D Wurster, M. Redmon. Preformulation studies on s-oxybutinin hydrochloride, an improved chemical entity (ICETM). 14th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1999, New Orleans, LA), PharmSci 1(4):S-496 (1999).
R. Rubinovitz and P. E. Luner. Quantitative analysis of crystalline form composition in binary powder mixtures by near-infrared reflectance spectroscopy. 38th Annual Eastern Analytical Symposium and Exposition (EAS), Somerset, NJ, November 14-19, 1999.
E. Oh and P.E. Luner. Surface energy determination of aqueous-based cellulose ether films. 13th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1998, San Francisco, CA), PharmSci 1(1):S-271 (1998).
P.E. Luner, C.P. Freed and E. Oh. Comparison of the wetting effects of micellar solutions of bile salts and lipids. 13th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1998, San Francisco, CA), PharmSci 1(1):S-260 (1998).
R.L. Brashear, D.R. Flanagan, P.E. Luner, J.J. Seyer, and M.S. Kemper. Diffuse reflectance near-infrared spectroscopy as a non-destructive analytical technique for polymer implants and microspheres. 13th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1998, San Francisco, CA). PharmSci 1(1):S-20 (1998).
J.J. Seyer, A.D. Patel, P.E. Luner and M.S. Kemper. Determination of percent crystallinity and polymorphic form in binary and ternary powder mixtures using diffuse reflectance near infrared spectroscopy. 13th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1998, San Francisco, CA), PharmSci 1(1):S-409 (1998).
J.J. Seyer, P.E. Luner, M.S. Kemper, S. Majuru. Amorphous content determination in semi-crystalline mixtures using diffuse reflectance near-infrared spectroscopy. 12th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1997, Boston, MA). Pharm. Res. 14(11):S-445 (1997).
S. Majuru, P.E. Luner, M.S. Kemper, J.J. Seyer. Analysis of crystalline forms and quantitation of mixtures of crystalline forms using near-infrared reflectance spectroscopy. 12th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1997, Boston, MA). Pharm. Res. 14(11):S-198 (1997).
P.E. Luner, C.P. Freed, E. Oh. Analysis of the wetting of bile salt-lipid micellar solutions, surfactants and USP dissolution media. 12th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1997, Boston, MA). Pharm. Res. 14(11):S-190 (1997).
E. Oh and P.E. Luner. Surface energetics of ethylcellulose films and the influence of plasticizers. 12th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1997, Boston, MA). Pharm. Res. 14(11):S-628 (1997).
P.E. Luner, K. Wong, N.L. Testa, S.R. Babu and S.C. Mehta. Evaluation of the wettability of a hydrophobic drug by surfactants used in dissolution testing. 9th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1994), San Diego, CA. Pharm. Res. 11(10):S241 (1994).
P.E. Luner, S.R. Babu and G.W. Radebaugh. The effect of bile salts, lecithin and dietary lipids on the solubility of gemfibrozil. 8th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1993), Lake Buena Vista, FL. Pharm. Res. 10(10):S262 (1993).
P.E. Luner and G.L. Amidon. Description and simulation of a multiple mixing-tank model to predict the effect of bile sequestrants on bile salt excretion. 5th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1990), Las Vegas, NV. Pharm. Res. 7(9):S121 (1990).
P.E. Luner and G.L. Amidon. Determination of ion-exchange and adsorption components of bile salt binding to cholestyramine. 4th Annual Meeting of the American Association of Pharmaceutical Scientists (October 1989), Atlanta, GA. Pharm. Res. 6(9):S150 (1989).
P.E. Luner and G.L. Amidon. Evaluation of factors affecting the binding of bile salts to sequestrants. 3rd Annual Meeting of the American Association of Pharmaceutical Scientists (November 1988), Orlando, FL. Pharm. Res. 5(10):S140 (1988).
E.F. Fiese and P. Luner. Development of a laboratory test method for predicting milling conditions for drug substances. 133rd Annual Meeting of the American Pharmaceutical Association (March 1986), San Francisco, CA.

Publications | Key Presentations | Abstracts

REFEREED JOURNAL PUBLICATIONS

A. Kalra, P.E. Luner, L.S. Taylor, S.R. Byrn, T. Li. Gaining thermodynamic insight from distinct glass formation kinetics of structurally similar organic compounds. J. Pharm. Sci. 107(1):192-202, 2018. link

K.Dave, P.E. Luner C. Forness, D. Baker, C. Jankovsky, and S. Chen. Feasibility of Focused Beam Reflectance Measurement (FBRM) to analyze pharmaceutical suspensions in preclinical development. AAPS PharmSciTech. (2017). link

C.M. Lee, P.E. Luner, K. Locke, K. Briggs. Application of an Artificial Stomach-Duodenum Reduced Gastric pH Dog Model for Formulation Principle Assessment and Mechanistic Performance Understanding. J. Pharm. Sci. 106 (8): 1987-1997, 2017. link

P.D. Jager, T. Bramante and P.E. Luner. Assessment of Pharmaceutical Powder Flowability using Shear Cell-Based Methods and Application of Jenike’s Methodology. J. Pharm. Sci. 104(11):3804-3813 (2015). link

P.E. Luner and J.J. Seyer. Assessement of crystallinity in processed sucrose by Near Infrared Spectroscopy and application to Lyophiles. J. Pharm. Sci. 103(9), 2884-2895, (2014) (Special issue dedicated to Prof. George Zografi). link

S. Mehrens, P.E. Luner. Application of Raman spectroscopy in establishing solid form integrity for a highly polymorphic API. Amer. Pharm. Rev.16(5):24-36 (2013). link

P.E. Luner. Solid form diversity of commonly used tableting excipients and its impact. Eur. Pharm. Rev. 18(3):53-63 (2013).

P.E. Luner, Y. Zhang, Y. Abramov and M.T. Carvajal. The impact of particle size reduction method on the surface properties of molecular crystals using Inverse Gas Chromatography. Crystal Growth and Design, 12(11): 5271-5282 (2012). link

Gift AD, Luner PE, Luedeman L, Taylor LS. Manipulating hydrate formation during high shear wet granulation using polymeric excipients. J. Pharm. Sci. 98 (12), 4670-4683 (2009).

Morris DG, Truitt BF, Kong, A, Leyva N, Luner PE. Influence of Formulation Composition and Processing on the Content Uniformity of Low-Dose Tablets Manufactured at Kilogram Scale. Pharm Dev Technol, 14 (5), 451 – 460 (2009). link

Gift AD, Luner PE, Luedeman L, Taylor LS. Influence of polymeric excipients on crystal hydrate formation kinetics in aqueous slurries. J. Pharm. Sci. 97 (12): 5198-5211 (2008).

Luner PE, Patel AD. Quantifying Crystal Form Content in Physical Mixtures of (±)-Tartaric Acid and (+)-Tartaric Acid Using Near Infrared Reflectance Spectroscopy. AAPS PharmSciTech. 2005; 06(02): E245-E252. link

Luner PE, Waterman KC; (USA). Assignee. 2004 20040420. Pharmaceutical compositions of atorvastatin. Application: US. US patent 2004-828398.

M.P. Seiler, P. Luner, T.O. Moninger, P.H. Karp, S. Keshavjee and J. Zabner. Thixotropic solutions enhance viral-mediated gene transfer to airway epithelia. American Journal of Respiratory Cell & Molecular Biology 27: 133-140 (2002).

P.E. Luner, A.D. Patel and D.C. Swenson. (+/-)-tartaric acid. Acta Crystallographica – Section C – Crystal Structure Communications 58: O333-O335 (2002). link

J. J. Seyer, P. E. Luner. Determination of crystallinity in the presence of excipients using diffuse reflectance near-infrared spectroscopy. Pharm. Dev. Tech. 6(4):1-10 (2001).

P.E. Luner and E. Oh. Characterization of the surface free energy of cellulose ether films. Colloids and Surfaces A: Physicochemical and Engineering Aspects. 181(1-2):31-48 (2001). link

A.D. Patel, P.E. Luner and M.S. Kemper. Low level determination of polymorph composition in binary powder mixtures using NIRS. J. Pharm. Sci. 90(3):360-370, (2001).

P. E. Luner and D. VanDer Kamp. Wetting characteristics of media emulating gastric fluids. Int. J. Pharm. 212 (1):81-91 (2001).

P. E. Luner and D. VanDer Kamp. Wetting behavior of bile salt-lipid dispersions and dissolution media patterned after intestinal fluids. J. Pharm. Sci. 90 (3):348-359 (2001).

P. E. Luner, L. E. Kirsch, S. Majuru, E. Oh, A.B. Joshi, D.E. Wurster and M.P. Redmon. Preformulation Studies on the s-isomer of oxybutynin hydrochloride, an improved chemical entity (ICETM). Drug Devel. Indust. Pharm. 27 (4):318-326 (2001).

L.E. Kirsch, X. Zhang, W. Muangsiri, M.P. Redmon, P.E. Luner, D.E. Wurster. Development of a lyophilized formulation for (R,R)-Formoterol (L)-Tartrate. Drug Devel. Indust. Pharm. 27 (1):89-96 (2001).

A.D. Patel, P. E. Luner, and M. S. Kemper. Quantification of mixtures of polymorphs in binary and multi-component mixtures using near infrared diffuse reflectance spectroscopy. Int. J. Pharm. 206 (1-2):63-74 (2000).

J. J. Seyer, P. E. Luner, and M. S. Kemper. Application of diffuse reflectance near-infrared spectroscopy for determination of crystallinity. J. Pharm. Sci. 89 (10):1305-1316 (2000).

P.E. Luner. Wetting properties of bile salt solutions and dissolution media. J. Pharm. Sci. 89 (3):382-395 (2000).

P.E. Luner, S. Majuru, J.J. Seyer, M.S. Kemper. Quantifying crystalline form composition in binary powder mixtures using near-infrared reflectance spectroscopy. Pharm. Dev. Tech. 5(2):231-246 (2000).

E. Oh and P.E. Luner. Surface energetics of ethylcellulose films and the influence of plasticizers. Int. J. Pharm. 188 (2):203-219 (1999).

R.L. Brashear, D.R. Flanagan, P.E. Luner, J.J. Seyer, and M.S. Kemper. Diffuse reflectance near-infrared spectroscopy as a non-destructive analytical technique for polymer implants. J. Pharm. Sci. 88 (12):1348-1353 (1999).

P.E. Luner, S.R. Babu and S. Mehta. Wettability of a hydrophobic drug by surfactant solutions. Int. J. Pharm. 128:29-44 (1996).

P.E. Luner, S.R. Babu and G.W. Radebaugh. The effect of bile salts and lipids on the physicochemical behavior of gemfibrozil. Pharm. Res. 11:1755-1760 (1994).

P.E. Luner and G.L. Amidon. Description and simulation of a multiple mixing-tank model to predict the effect of bile sequestrants on bile salt excretion. J. Pharm. Sci. 82:311-318 (1993).

P.E. Luner, and G.L. Amidon. Equilibrium and kinetic factors influencing bile sequestrant efficacy. Pharm. Res. 9:670-676 (1992).

Publications | Key Presentations | Abstracts | Home

KEY PRESENTATIONS

“Understanding process induced phase transformation in solid dosage form development,” American Association of Pharmaceutical Scientists (AAPS) eLearning Webinar, April 2, 2015.

“The impact of excipient solid form diversity and variation on pharmaceutical manufacturing,” 11th Annual Garnet E. Peck Symposium, “Pharmaceutical Manufacturing and Regulatory Issues,” March 7, 2014. Purdue University, West Lafayette, IN.

“Toward Understanding API Phase Transformations Due to Processing for Oral Solid Dosage Forms,” FDA ONDQA – CEDR, Oct. 26, 2006, Rockville, MD.

“Unit Operation Effects on API Properties,” 48th Annual Land O’Lakes International Industrial Pharmaceutical Research and Development Conference. June 5-9, 2006, Merrimac, Wisconsin

“Pharmaceutical Applications of Near Infrared Spectroscopy and its use as a Physical Characterization Method,” University of Michigan, College of Pharmacy, Jan 20, 2006, Ann Arbor, MI.

“Applications of Infrared Reflectance Spectroscopy in Solid-State Characterization,” Purdue University, School of Pharmacy and Pharmacal Sciences, May 17, 2005, West Lafayette, IN.

“Impact of particle size in tablet development,” Mettler Toledo Particle Size Matters Workshop on Milling, Granulation, Liquid Formulation and Tableting, Aug 25, 2005, Iselin, NJ.

“Surface Free Energy of Cellulose Ether Films,” 2ndInternational Conference on Contact Angle, Wetting and Adhesion, K. Mittal, Organizer. Newark, NJ, June 21-23, 2000. (E. Oh, co-author).

“Wetting of pharmaceutical surfaces by bile salt and bile salt-lipid solutions,” 72nd American Chemical Society Colloid and Surface Science Symposium, Pennsylvania State University, June 21-24, 1998. (E. Oh and C.F. Freed, co-authors)

Publications | Key Presentations | Abstracts | Home

ABSTRACTS

K. Dave, C. Forness, D. Baker, C. Jankovsky, P. Luner, S. Chen. Use of Focused Beam Reflectance Measurement (FBRM) for Analysis of Pharmaceutical Suspensions. Poster presentation at the 2014 AAPS Annual Meeting and Exposition; November 2-6, San Diego, CA, Poster T3301.

P. Jager, T. Bramante, P. Luner. A quantitative assessment of powder flow in hoppers. AAPS Northeast Regional Discussion Group Meeting, Rocky Hill, CT, April 19, 2013.

Li Zhong, C. Jankovsky, C. Telang, P. Luner, and C. Bhugra. Practicality of stress testing in early amorphous drug development to select dispersion matrix composition. Poster presentation at the 2012 AAPS Annual Meeting and Exposition, October 14-17, Chicago, IL. Poster W5201.

K. Briggs, K. Locke, P. Luner, C-M. Lee. Development of an artificial stomach-duodenum system model (ASD). AAPS Northeast Regional Discussion Group Summer Conference, Merck Research Laboratories, Boston MA, September 2, 2011.

P.E. Luner, K. Sagawa. Assessment of the impact of crystal form on bioavailability using pharmacokinetic modeling. 10th International Workshop on Physical Characterization of Pharmaceutical Solids (ASSA International), Bamberg, Germany June 8 – 13, 2008.

I. Colon-Rivera, P. Luner, T. Shire. Application of Intrinsic Dissolution Analysis for Supporting Active Pharmaceutical Ingredient Particle Size Assessment. AAPS Annual Meeting, Nov 2008, The AAPS Journal Vol. 8, No. S2.

D. Morris, B.F. Truitt, Y. Yang, A. Kong, P. Luner. Laboratory-Scale Assessment of the Impact of Excipients and Processing Method on Low-dose Tablet Content Uniformity. AAPS Annual Meeting, Nov 2006, San Diego CA. The AAPS Journal Vol. 8, No. S2, Abstract T2227.

Hai Wang, Jan Soto, Jennifer Chu, Paul Luner, Thomas Vendola. Prediction of Amount of Granulating Liquid Using a Mixer Torque Rheometer: Correlation of Torque Profile with Granule Growth Behavior. AAPS Annual Meeting, Nashville, TN, 2005. The AAPS Journal Vol. 7, No. S2, Abstract W5250 (2005).

T. Vendola, H. Wang, P. Luner, B. Truitt. An API sparing method to facilitate rapid development of a high drug loading wet granulated formulation- a case study. Annual Meeting of the American Association of Pharmaceutical Scientists (November, 2004, Baltimore, MD), Poster #W4146.

J.J. Seyer and P.E. Luner. Determination of crystallinity in lyophilized cakes using diffuse reflectance near-infrared spectroscopy. 17th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2002, Toronto, Canada), Poster #T2321.

A.D. Patel, D. Swenson, and P.E. Luner. Solid state characterization and crystal structure of dl-tartaric acid. 15th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2000, Indianapolis, IN), PharmSci 2(4): 3587.

D. VanDer Kamp and P.E. Luner. Wetting properties of biorelevant media. 15th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2000, Indianapolis, IN), PharmSci 2(4): 3322.

J.J. Seyer and P.E. Luner. Determination of crystallinity in processed sucrose using diffuse reflectance near-infrared spectroscopy and X-ray powder diffraction. 15th Annual Meeting of the American Association of Pharmaceutical Scientists (November 2000, Indianapolis, IN), PharmSci 2(4): 3573

A.D. Patel, P.E. Luner and M.S. Kemper. Solid-state determination of the optical purity of tartaric acid using near infrared reflectance spectroscopy. 14th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1999, New Orleans, LA), PharmSci 1(4):S-189 (1999).

L. Kirsch, X. Zhang, W. Muangsiri, P. Luner, D Wurster, M. Redmon. Development of lyophilized RR-formoterol (L) tartrate. 14th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1999, New Orleans, LA), PharmSci 1(4):S-271 (1999).

R. Rubinovitz and P. E. Luner. Quantitative analysis of crystalline form composition in binary powder mixtures by near-infrared reflectance spectroscopy. 38th Annual Eastern Analytical Symposium and Exposition (EAS), Somerset, NJ, November 14-19, 1999.

E. Oh and P.E. Luner. Surface energy determination of aqueous-based cellulose ether films. 13th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1998, San Francisco, CA), PharmSci 1(1):S-271 (1998).

P.E. Luner, C.P. Freed and E. Oh. Comparison of the wetting effects of micellar solutions of bile salts and lipids. 13th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1998, San Francisco, CA), PharmSci 1(1):S-260 (1998).

P.E. Luner, C.P. Freed, E. Oh. Analysis of the wetting of bile salt-lipid micellar solutions, surfactants and USP dissolution media. 12th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1997, Boston, MA). Pharm. Res. 14(11):S-190 (1997).

E. Oh and P.E. Luner. Surface energetics of ethylcellulose films and the influence of plasticizers. 12th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1997, Boston, MA). Pharm. Res. 14(11):S-628 (1997).

P.E. Luner, K. Wong, N.L. Testa, S.R. Babu and S.C. Mehta. Evaluation of the wettability of a hydrophobic drug by surfactants used in dissolution testing. 9th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1994), San Diego, CA. Pharm. Res. 11(10):S241 (1994).

P.E. Luner, S.R. Babu and G.W. Radebaugh. The effect of bile salts, lecithin and dietary lipids on the solubility of gemfibrozil. 8th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1993), Lake Buena Vista, FL. Pharm. Res. 10(10):S262 (1993).

P.E. Luner and G.L. Amidon. Description and simulation of a multiple mixing-tank model to predict the effect of bile sequestrants on bile salt excretion. 5th Annual Meeting of the American Association of Pharmaceutical Scientists (November 1990), Las Vegas, NV. Pharm. Res. 7(9):S121 (1990).

P.E. Luner and G.L. Amidon. Determination of ion-exchange and adsorption components of bile salt binding to cholestyramine. 4th Annual Meeting of the American Association of Pharmaceutical Scientists (October 1989), Atlanta, GA. Pharm. Res. 6(9):S150 (1989).

P.E. Luner and G.L. Amidon. Evaluation of factors affecting the binding of bile salts to sequestrants. 3rd Annual Meeting of the American Association of Pharmaceutical Scientists (November 1988), Orlando, FL. Pharm. Res. 5(10):S140 (1988).

E.F. Fiese and P. Luner. Development of a laboratory test method for predicting milling conditions for drug substances. 133rd Annual Meeting of the American Pharmaceutical Association (March 1986), San Francisco, CA.

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“Surface Free Energy of Cellulose Ether Films,” 2^ndInternational Conference on Contact Angle, Wetting and Adhesion, K. Mittal, Organizer. Newark, NJ, June 21-23, 2000. (E. Oh, co-author).