Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, 9th Edition

ANSEL\'S PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS, Ninth Edition......Page 1
Title Page......Page 3
Copyright......Page 4
WHAT IS NEW IN THIS EDITION?......Page 5
EXPLANATION OF THE SOAP FORMAT FOR CASE STUDIES......Page 6
ACKNOWLEDGMENTS......Page 7
Contents......Page 9
List of Physical Pharmacy Capsules......Page 10
OBJECTIVES......Page 11
THE HERITAGE OF PHARMACY......Page 13
DRUG STANDARDS......Page 17
THE FEDERAL FOOD, DRUG, AND COSMETIC ACT OF 1938......Page 21
THE PHARMACIST’S CONTEMPORARY ROLE......Page 29
CODE OF ETHICS OF THE AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS......Page 34
REFERENCES......Page 35
OBJECTIVES......Page 37
DRUG DISCOVERY AND DRUG DESIGN......Page 40
BIOLOGIC CHARACTERIZATION......Page 47
EARLY FORMULATION STUDIES......Page 52
THE INVESTIGATIONAL NEW DRUG APPLICATION......Page 54
THE NEW DRUG APPLICATION......Page 68
SUPPLEMENTAL, ABBREVIATED, AND OTHER APPLICATIONS......Page 72
INTERNATIONAL CONFERENCE ON HARMONIZATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE......Page 73
REFERENCES......Page 74
cGMP FOR FINISHED PHARMACEUTICALS......Page 76
ADDITIONAL cGMP REGULATORY REQUIREMENTS......Page 83
CURRENT GOOD COMPOUNDING PRACTICES......Page 85
PACKAGING, LABELING, AND STORAGE OF PHARMACEUTICALS......Page 89
APPLYING THE PRINCIPLES AND CONCEPTS......Page 98
REFERENCES......Page 99
OBJECTIVES......Page 100
THE NEED FOR DOSAGE FORMS......Page 101
GENERAL CONSIDERATIONS IN DOSAGE FORM DESIGN......Page 102
PHARMACEUTICAL INGREDIENTS AND EXCIPIENTS......Page 137
APPLYING THE PRINCIPLES AND CONCEPTS......Page 151
REFERENCES......Page 152
OBJECTIVES......Page 153
PRINCIPLES OF DRUG ABSORPTION......Page 155
DISSOLUTION AND DRUG ABSORPTION......Page 158
BIOAVAILABILITY AND BIOEQUIVALENCE......Page 163
BIOEQUIVALENCE OF DRUG PRODUCTS......Page 168
ROUTES OF DRUG ADMINISTRATION......Page 171
FATE OF DRUG AFTER ABSORPTION......Page 180
PHARMACOKINETIC PRINCIPLES......Page 184
REFERENCES......Page 193
POWDERS......Page 194
MEDICATED POWDERS......Page 203
GRANULES......Page 206
PHARMACEUTICS CASE STUDY......Page 210
APPLYING THE PRINCIPLES AND CONCEPTS......Page 211
REFERENCES......Page 212
OBJECTIVES......Page 213
HARD GELATIN CAPSULES......Page 214
CLEANING AND POLISHING CAPSULES......Page 223
SOFT GELATIN CAPSULES......Page 224
COMPENDIAL REQUIREMENTS FOR CAPSULES......Page 225
OFFICIAL AND COMMERCIALLY AVAILABLE CAPSULES......Page 227
INSPECTING, COUNTING, PACKAGING, AND STORING CAPSULES......Page 228
ORAL ADMINISTRATION OF SOLID DOSAGE FORMS......Page 230
PHARMACEUTICS CASE STUDY......Page 231
CLINICAL CASE STUDY......Page 232
APPLYING THE PRINCIPLES AND CONCEPTS......Page 233
REFERENCES......Page 234
TYPES OF TABLETS......Page 235
COMPRESSED TABLETS......Page 241
CHEWABLE TABLETS......Page 253
TABLET COATING......Page 254
PACKAGING AND STORING TABLETS......Page 260
OTHER SOLID DOSAGE FORMS FOR ORAL ADMINISTRATION......Page 262
CLINICAL CASE STUDY......Page 263
APPLYING THE PRINCIPLES AND CONCEPTS......Page 265
REFERENCES......Page 266
OBJECTIVES......Page 267
TERMINOLOGY......Page 268
EXTENDED-RELEASE ORAL DOSAGE FORMS......Page 269
DELAYED-RELEASE ORAL DOSAGE FORMS......Page 274
USP REQUIREMENTS AND FDA GUIDANCE FOR MODIFIED-RELEASE DOSAGE FORMS......Page 276
CLINICAL CONSIDERATIONS IN THE USE OF ORAL MODIFIED-RELEASE DOSAGE FORMS......Page 277
PHARMACEUTICS CASE STUDY......Page 278
CLINICAL CASE STUDY......Page 279
APPLYING THE PRINCIPLES AND CONCEPTS......Page 280
REFERENCES......Page 281
OINTMENTS......Page 282
COMPENDIAL REQUIREMENTS FOR OINTMENTS (2)......Page 287
GELS......Page 288
MISCELLANEOUS SEMISOLID PREPARATIONS: PASTES, PLASTERS, AND GLYCEROGELATINS......Page 289
FEATURES AND USE OF DERMATOLOGIC PREPARATIONS......Page 292
FEATURES AND USE OF OPHTHALMIC OINTMENTS AND GELS......Page 293
FEATURES AND USE OF RECTAL PREPARATIONS......Page 298
FEATURES AND USE OF VAGINAL PREPARATIONS......Page 299
PHARMACEUTICS CASE STUDY......Page 300
CLINICAL CASE STUDY......Page 301
REFERENCES......Page 303
OBJECTIVES......Page 304
PERCUTANEOUS ABSORPTION ENHANCERS......Page 305
PERCUTANEOUS ABSORPTION MODELS......Page 306
DESIGN FEATURES OF TRANSDERMAL DRUG DELIVERY SYSTEMS......Page 308
EXAMPLES OF TRANSDERMAL DRUG DELIVERY SYSTEMS......Page 313
GENERAL CLINICAL CONSIDERATIONS IN THE USE OF TDDSs......Page 317
PHARMACEUTICS CASE STUDY......Page 318
CLINICAL CASE STUDY......Page 319
REFERENCES......Page 320
SUPPOSITORIES......Page 322
SOME FACTORS OF DRUG ABSORPTION FROM RECTAL SUPPOSITORIES......Page 324
SUPPOSITORY BASES......Page 325
PREPARATION OF SUPPOSITORIES......Page 328
RECTAL SUPPOSITORIES......Page 334
VAGINAL SUPPOSITORIES......Page 335
PACKAGING AND STORAGE......Page 337
CLINICAL CASE STUDY......Page 338
REFERENCES......Page 340
OBJECTIVES......Page 341
SOLUBILITY......Page 342
SOME SOLVENTS FOR LIQUID PREPARATIONS......Page 346
PREPARATION OF SOLUTIONS......Page 348
ORAL SOLUTIONS AND PREPARATIONS FOR ORAL SOLUTION......Page 350
SYRUPS......Page 355
ELIXIRS......Page 363
TINCTURES......Page 367
TOPICAL SOLUTIONS AND TINCTURES......Page 368
VAGINAL AND RECTAL SOLUTIONS......Page 373
TOPICAL TINCTURES......Page 374
TOPICAL ORAL (DENTAL) SOLUTIONS......Page 375
MISCELLANEOUS SOLUTIONS......Page 376
NONAQUEOUS SOLUTIONS......Page 378
EXTRACTION METHODS FOR PREPARING SOLUTIONS......Page 379
PHARMACEUTICS CASE STUDY......Page 382
CLINICAL CASE STUDY......Page 383
APPLYING THE PRINCIPLES AND CONCEPTS......Page 384
REFERENCES......Page 385
OBJECTIVES......Page 386
SUSPENSIONS......Page 387
EMULSIONS......Page 404
GELS AND MAGMAS......Page 415
AEROSOLS......Page 424
PHARMACEUTICS CASE STUDY......Page 436
CLINICAL CASE STUDY......Page 437
APPLYING THE PRINCIPLES AND CONCEPTS......Page 439
REFERENCES......Page 440
INJECTIONS......Page 441
SMALL-VOLUME PARENTERALS......Page 472
INSULINS......Page 476
LARGE-VOLUME PARENTERALS......Page 485
SPECIAL CONSIDERATIONS ASSOCIATED WITH PARENTERAL THERAPY......Page 493
OTHER INJECTABLE PRODUCTS: PELLETS OR IMPLANTS......Page 496
IRRIGATION AND DIALYSIS SOLUTIONS......Page 497
PHARMACEUTICS CASE STUDY......Page 498
CLINICAL CASE STUDY......Page 499
APPLYING THE PRINCIPLES AND CONCEPTS......Page 500
REFERENCES......Page 501
TYPES OF IMMUNITY......Page 503
PRODUCTION OF BIOLOGICS......Page 505
STORAGE, HANDLING, AND SHIPPING OF BIOLOGICS......Page 506
ADMINISTRATION AND TOXICITY ASSOCIATED WITH BIOLOGIC PRODUCTS......Page 514
ADMINISTRATION OF BIOLOGICS BY HEALTH CARE PROVIDERS......Page 517
NATIONAL VACCINE ADVISORY COMMITTEE......Page 518
CHILDHOOD IMMUNIZATION SCHEDULE......Page 519
ADULT IMMUNIZATION SCHEDULE......Page 526
VACCINATION ADVOCACY FROM PHARMACISTS......Page 534
ADDITIONAL IMMUNIZATION INFORMATION RESOURCES......Page 535
RESPONDING TO BIOTERRORISM......Page 536
PHARMACEUTICS CASE STUDY......Page 537
CLINICAL CASE STUDY......Page 538
REFERENCES......Page 539
OPHTHALMIC DRUG DELIVERY......Page 541
PHARMACOLOGIC CATEGORIES OF OPHTHALMIC DRUGS......Page 542
PHARMACEUTICAL REQUIREMENTS......Page 543
PACKAGING OPHTHALMIC SOLUTIONS AND SUSPENSIONS......Page 550
PROPER ADMINISTRATION OF OPHTHALMIC SOLUTIONS AND SUSPENSIONS......Page 551
CONTACT LENSES AND CARE AND USE SOLUTIONS......Page 553
NASAL PREPARATIONS......Page 557
OTIC PREPARATIONS......Page 562
PHARMACEUTICS CASE STUDY......Page 564
CLINICAL CASE STUDY......Page 565
APPLYING THE PRINCIPLES AND CONCEPTS......Page 566
REFERENCES......Page 567
OBJECTIVES......Page 569
BACKGROUND INFORMATION......Page 570
DIAGNOSTIC IMAGING......Page 572
THERAPEUTIC USE OF RADIOPHARMACEUTICALS......Page 573
RADIOPHARMACEUTICALS......Page 576
POSITRON EMISSION TOMOGRAPHY......Page 583
DRUG ANTIDOTE FOR RADIATION EXPOSURE......Page 587
NONRADIOACTIVE PHARMACEUTICAL USE IN NUCLEAR MEDICINE......Page 588
PRACTICE OF NUCLEAR PHARMACY......Page 589
CLINICAL CASE STUDY......Page 597
APPLYING THE PRINCIPLES AND CONCEPTS......Page 598
REFERENCES......Page 599
OBJECTIVES......Page 601
TECHNIQUES USED TO PRODUCE BIOTECHNOLOGIC PRODUCTS......Page 603
PRODUCTS OF BIOTECHNOLOGY......Page 607
TISSUE PLASMINOGEN ACTIVATORS......Page 634
THE FUTURE OF BIOTECHNOLOGY PRODUCTS......Page 641
FDA OFFICE OF BIOTECHNOLOGY PRODUCTS......Page 643
PATIENT INFORMATION FROM THE PHARMACIST......Page 644
PHARMACIST SELF-HELP WITH BIOTECHNOLOGY DRUGS......Page 646
PHARMACEUTICS CASE STUDY......Page 651
CLINICAL CASE STUDY......Page 652
REFERENCES......Page 654
OBJECTIVES......Page 656
TOPICAL ADMINISTRATION......Page 657
ORAL ADMINISTRATION......Page 661
VAGINAL ADMINISTRATION......Page 663
OPHTHALMICS......Page 665
PARENTERAL ADMINISTRATION......Page 667
PEGYLATED DOSAGE FORMS......Page 670
IMPLANTS......Page 671
OTHER NOVEL DELIVERY SYSTEMS......Page 674
REFERENCES......Page 676
APPENDIX A: Definitions of Selected Drug Categories......Page 678
APPENDIX B: Glossary of Pharmaceutical Terms and Dosage Forms......Page 686
SYSTEMS OF PHARMACEUTICAL MEASUREMENT......Page 689
TECHNIQUES OF PHARMACEUTICAL MEASUREMENT......Page 694
REFERENCES......Page 698
Index......Page 699