000			01442nam a2200229Ia 4500
003			NULRC
005			20250520100622.0
008			250520s9999 xx 000 0 und d
020			_a9780849339936
040			_cNULRC
050			_aRS 199.S73 .A54 2010
100			_aAkers, Michael J. _eauthor
245		0	_aSterile drug products : _bformulation, packaging, manufacturing, and quality / _cMichael J. Akers
260			_aNew York : _bInforma Healthcare, _cc2010
300			_aix, 505 pages : _billustrations ; _c26 cm.
365			_bUSD159.85
504			_aIncludes bibliographical references and index.
505			_aIntroduction, scope, and history of sterile products -- Characteristics of sterile dosage forms -- Types of sterile dosage forms -- Sterile product packaging systems -- Overview of product development -- Formulation components (solvents and solutes) -- Sterile products packaging chemistry -- Formulation and stability of solutions -- Dispersed systems -- Formulation of freeze-dried powders -- Overcoming formulation problems and some case studies -- Overview of sterile product manufacturing -- Contamination control -- Sterile manufacturing facilities
520			_aThis book is based primarily on courses that I thought on the basic principles of sterile dosage formulation, packaging, manufacturing, and quality control and assurance over a span of 35 years.
650			_aDOSAGE FORMS STANDARDS
942			_2lcc _cBK
999			_c9597 _d9597