Best practices for extractables and leachables in orally inhaled and nasal drug products: An overview of the PQRI recommendations

Pharmaceutical Research

Volumn 25, Issue 4, 2008, Pages 727-739

  Norwood, Daniel L ^a   Paskiet, Diane ^b   Ruberto, Michael ^c   Feinberg, Thomas ^d   Schroeder, Alan ^e   Poochikian, Guirag ^e,f   Wang, Qingxi ^g   Deng, Tian Jing ^h,i   Degrazio, Fran ^j   Munos, Melinda K ^k   Nagao, Lee M ^k  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^b West Monarch Analytical Laboratories   (United States)

^c Ciba Expert Services   (United States)

^d CATALENT PHARMA SOLUTIONS   (United States)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^f Poochikian Pharma Consulting   (United States)

^g MERCK RESEARCH LABORATORIES   (United States)

^h Pharmaceutical Product Development   (United States)

ⁱ BioDuro Inc   (United States)

^j West Pharmaceutical Services Inc   (United States)

^k Drinker Biddle and Reath   (United States)

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Author keywords

Controlled extraction studies; Leachables; OINDP; Pharmaceutical development; PQRI

Indexed keywords

BECLOMETASONE DIPROPIONATE; FLUTICASONE PROPIONATE; IPRATROPIUM BROMIDE; IPRATROPIUM BROMIDE PLUS SALBUTAMOL SULFATE; NEDOCROMIL SODIUM; NOSE SPRAY; ORCIPRENALINE; PIRBUTEROL ACETATE; SALBUTAMOL; SALMETEROL XINAFOATE; TRIAMCINOLONE ACETONIDE;

CONTAINER; DRUG IMPURITY; DRUG PACKAGING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; INDUSTRY; METERED DOSE INHALER; NOTE; ORGANIZATION; PATIENT CARE; POWDER INHALER; PRIORITY JOURNAL; SCIENTIST; SHELF LIFE; SUSPENSION;

ADMINISTRATION, INHALATION; ADMINISTRATION, INTRANASAL; ADMINISTRATION, ORAL; BENCHMARKING; CONSUMER PRODUCT SAFETY; DRUG CONTAMINATION; DRUG PACKAGING; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; GUIDELINES AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL;

EID: 43349096556     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-007-9521-z     Document Type: Note

References (3)

1. D. Ball, J. Blanchard, D. Jacobson-Kram, R. McClellan, T. McGovern, D. L. Norwood, M. Vogel, R. Wolff, and L. Nagao. Development of safety qualification thresholds and their use in drug product evaluation. Toxicol. Sci. 97(2):226-236 (2007).
2. IPAC-RS. Good manufacturing practices guideline for suppliers of components for orally inhaled and nasal drug products. International Pharmaceutical Aerosol Consortium on Regulation and Science(2006).
3. D. L. Norwood. Understanding the challenges of extractables and leachables for the pharmaceutical industry-safety and regulatory environment for pharmaceuticals. Am. Pharm. Rev. 10(2):32-39 (2007).