Handbook of Pharmaceutical Manufacturing Formulations - Vol 1 of 6

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products
Introduction
Background
Methods to Document BA and BE
Comparison of BA Measures in BE Studies
Documentation of BA and BE
Special Topics

Abbreviated Directions
API
Bio vs Production Batches
Cleaning Validation
Coatings
Compliance with Regulatory Requirements
Compression Process Control
Content Uniformity
Cross-Contamination
Desegregation of Powders
Disintegration Test
Dissolution
Disintegration and Dissolution
Drug Substance Characterization
Drying Process
Dyes in Formulations
Equipment
Excipients
Fill Weights
Final Packaging
Final Testing
Fines
Formula Excesses
Geometric Dilution
Granulation/Mix Analysis
Ingredient Warning
In-Process Testing
Loss on Drying (LOD)
Manufacturing Yields
Master Formula
Multiple-Item Entries
Multiple Strengths of Formulations
Novel Drug Delivery Systems
Particle Coating
Preservatives in Compressed Solid Dosage Formulations
Punch Size and Shape
Reworking Culls
Scale-Up
Segregation
Sifting Ingredients and Granules
Specifications
Stability Testing
Storage of In-Process Material
Tablet Friability
Tablet Manufacturing
Tablets
Water-Purified USP
Weight Variation and Content Uniformity
Wet Granulation vs Dry Granulation or Direct Compression

Acetaminophen, Ibuprofen, and Orphenadrine Tablets (250 mg/200 mg/200 mg
Acetaminophen, Norephedrine, and Phenyltoloxamine Tablets (300 mg/25 mg/22 mg)
Acetaminophen and Phenprobamat Tablets (200 mg/200 mg)
Acetaminophen and Orphenadrine Citrate Tablets (450 mg/35 mg)
Acetaminophen Tablets, Chewable
Acetaminophen, Dextropropoxyphen Hydrochloride Tablets (325 mg/32 mg)
Acetaminophen and Codeine Tablets [34]
Acetaminophen, Salicylamide, Caffeine, and Codeine Tablets (150 mg/200 mg/50 mg/10 mg)
Acyclovir Tablets [162]
Acyclovir Water-Dispersible Tablets (800 mg)
Albendazole Tablets (200 mg)
Alendronate Tablets [38]
Alendronate Tablets, Effervescent (10 mg) Alendronate Sodium Tablets (50 mg 44
Allopurinol Tablets (100 mg) [84]
Allopurinol Tablets (300 mg)
Alprazolam Tablets (0.25 mg/0.50 mg/1.0 mg)
4-Amino-1-hydroxybutylidene-1,1-bisphosphonic Acid Tablets (5 mg)
Aminophylline Tablets (100 mg)
Amiodarone Tablets (200 mg)
Amlodipine Besylate Tablets [9]
Amitriptyline Tablets (50 mg) [42]
Amoxicillin Tablets (250 mg/500 mg/1 g)
Amoxicillin Trihydrate and Clavulanate Potassium Tablets (500 mg/125 mg).
Amoxicillin and Potassium Clavulanate Tablets (250 mg/62.5 mg)
Amphetamine Salts Tablets
Atenolol Tablets (50 mg/100 mg)
Atorvastatin Tablets (10 mg/20 mg)
Azithromycin Tablets (250 mg)
Benzafibrate Tablets (200 mg)
Benazepril Hydrochloride Tablets
Betamethasone Tablets (0.50 mg)
BIRB 796 Tablets (100 mg)
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Bromazepam Tablets (3 mg)
Bromhexine Tablets (8 mg)
Bromocriptine Tablets
Buflomedil Hydrochloride Tablets (150 mg/300 mg)
Buflomedil Hydrochloride Tablets (600 )
Bupropion Hydrochloride Tablets
Buspirone Hydrochloride Tablets7
Buspirone Hydrochloride Tablets, Controlled-Release (30 mg)
Captopril Tablets (25 mg)
Carbamazepine Tablets (200 mg)
Carbamazepine Tablets (200 mg)
Carbidopa and Levodopa Tablets
Carisoprodol Tablets
Carvedilol Tablets
Cefadroxil Dispersible Tablets (250 mg)
Cefdinir Tablets (300 mg)
Cefixime Tablets (400 mg)
Cefprozil Tablets (250 mg)
Celecoxib Tablets
Cephalexin Tablets
Cetirizine and Pseudoephedrine Delayed-Release Tablets (5 mg/120 mg)
Cetirizine Hydrochloride Tablets (10 mg)
Chlorcyclizine Hydrochloride Tablets (50 mg)
Chlordiazepoxide and Clinidium Bromide Tablets (5 mg/2.5 mg)
Chlordiazepoxide Tablets (10 mg)
Chloroquine Tablets (250 mg)
Choline Theophyllinate Tablets (100 mg)
Chymotrypsine Tablets (25 mg)
Cilazapril Tablets (2.5 mg)
Cimetidine Tablets (200 mg)
Ciprofloxacin Tablets (500 mg)
Ciprofloxacin Tablets (750 mg)
Cisapride Tablets (5 mg
Citalopram Hydrobromide Tablets
Clarithromycin Tablets (250 mg/500 mg)
Clenbuterol Tablets (20 mcg)
Clindamycin Tablets (20 mg)
Clobazam Tablets (10 mg)
Clomifen Citrate Tablets (50 mg)
Clomipramine Hydrochloride Tablets, Effervescent (300 mg)
Clomipramine Hydrochloride Tablets, Buccal (10 mg)
Clonazepam Tablets (1 mg/2 mg)
Clonidine Tablets (0.1 mg/0.2 mg/0.3 mg)
Clopidogrel Bisulfate Tablets (75 mg)
Codeine, Acetaminophen, and Pentobarbital Tablets (15 mg/300 mg/30 mg)
Conjugated Estrogens (0.3-2.50 mg)
Conjugated Estrogens and Medroxyprogesterone Tablets
Coumadin Tablets
Cyclobenzaprine Hydrochloride Tablets (10 mg) [64]
Cyproheptadine Tablets (4 mg)
Dapsone Tablets (50 mg)
Desloratidine Tablets (5 mg)
Desogestrel and Ethinyl Estradiol Tablets (0.15 mg/0.03 mg)
Diazepam Tablets (2 mg/5 mg/10 mg)
Diclofenac Sodium Tablets (25 mg)
Diclofenac Sodium Tablets (50 mg)
Diclofenac Sodium Tablets (100 mg)
Didanosine Tablets (50 mg)
Diethylcarbamazine Tablets (100 mg)
Difenoxin and Atropine Tablets (0.5 mg/0.025 mg)
Digoxin Tablets (0.125 mg/0.25 mg) [92]
Diltiazem Hydrochloride Tablets (60 mg)
Diltiazem Tablets 60 mg [95]
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets (2.5 mg/0.025 mg)
Divalproate Sodium Tablets (125 mg) [121]
Divalproex Sodium Tablets (400 100
Doxazosin Mesylate Tablets (1 mg/2 mg/4 mg/8 mg) [112]
Doxycycline Hydrochloride Tablets (100 mg) [91]
Enalapril Maleate Tablets (2.5 mg/5 mg/10 mg/20 mg) [66]
Enalapril Maleate Tablets (10 mg)
Enoxacin Tablets (400 mg)
Erythromycin Ethylsuccinate Tablets (400 mg)
Erythromycin Particle-Coated Tablets (150 mg)
Erythromycin Tablets (100 mg)
Erythromycin Tablets (100 mg)
Erythromycin Tablets (500 mg)
Estazolam Tablets (1 mg)
Estazolam Tablets (2 mg)
Estradiol Tablets (0.5 mg/1 mg/2 mg) [85]
Estropipate Tablets (0.626 mg/1.25 mg/2.25 mg/5 mg)
Ethambutol Tablets (400 mg)
Ethambutol Tablets (800 mg)
Etophylline and Theophylline Tablets (100 mg/22 mg)
Etophylline and Theophylline Tablets (100 mg/22 mg)
Famciclovir Tablets (125 mg/250 mg)
Famotidine Tablets (20 mg) [146]
Famotidine Tablets (40 mg)
Fexofenadine Tablets (30 mg/60 mg/180 mg) [26]
Fexofenadine and Pseudoephedrine Tablets (10 mg/240 mg) [111]
Finasteride Tablets (5 mg)
Fluconazole Tablets (50 mg/100 mg/200 mg) [75]
Fluvoxamine Maleate Tablets (50 mg)
Fluoxetine Hydrochloride Tablets (10 mg/20 mg/40 mg) [33]
Fluoxetine Hydrochloride Tablets (12.5 mg/25.0 mg) Controlled-Release Bilayer
Fosinopril Tablets (20 mg) [133]
Fucidine Tablets (125 mg)
Furazolidone Tablets (100 mg)
Furosemide Tablets (40 mg) [7]
Furosemide Tablets (40 mg)
Furosemide Tablets (200 mg)
Gabapentin Tablets (600 mg)
Galanthamine Hydrobromide Tablets (1 mg)
Gemfibrozil Tablets (600 mg) [114]
Glibenclamide Tablets (2.5 mg)
Glibenclamide Tablets (5 mg)
Gliclazide Tablets (80 mg)
Glimepiride Tablets (1 mg/2 mg) [129]
Glipizide Tablets (5 mg) [71]
Glipizide Tablets CR (5 mg)
Glyburide and Metformin Tablets (250 mg/500 mg; 1.25 mg/2.50 mg) [124]
Glyburide Tablets (5 mg) [81]
Griseofulvin Tablets (125 mg)
Griseofulvin Tablets (500 mg)
Hydrochlorothiazide and Potassium Chloride (50 mg/300 mg)
Hydrochlorothiazide Tablets (50 mg) [10]
Hydrochlorothiazide Tablets (50 mg)
Hydrocodone and Acetaminophen Tablets (5.0 mg/500 mg; 7.50 mg/750 mg)
Hydrocodone and Ibuprofen Tablet
Hydroxyzine Tablets [132]
Hyoscine Butyl Bromide Tablets (10 mg)
Ibuprofen Tablets (400 mg) [19]
Ibuprofen Tablets (400 mg)
Ibuprofen Tablets (600 mg)
Imipramine Tablets (25 mg)
Irbesartan Tablets (75 mg/150 mg/300 mg) [149]
Isoniazid Tablets (100 mg)
Isosorbide Dinitrate Tablets (5 mg) [68]
Isosorbide Dinitrate Tablets (10 mg)
Ketotifen Tablets (1 mg)
Lamotrigine Tablets (100 mg)
Lansoprazole Tablets (10 mg or 20 mg)
Lansoprazole Tablets (10 mg or 20 mg)
Lansoprazole Tablets Chewable (10 mg/20 mg)
Lansoprazole Tablets, Rapid Dissolution (20 mg)
Levamisole Hydrochloride Tablets (40 mg)
Levamisole Tablets (150 mg)
Levofloxacin Tablets (250 mg) [69]
Levothyroxine Tablets [4]
Levothyroxine Tablets (50 mcg) [25]
Levothyroxine Tablets (0.025 mg)
Linezolid Tablets (400 mg)
Lisinopril Tablets (10 mg) [52]
Lomefloxacin Hydrochloride Tablets (400 mg)
Loperamide Hydrochloride Tablets (2 mg)
Loratadine and Pseudoephedrine Sulfate Tablets (10 mg/240 mg) [127]
Loratadine Tablets (10 mg) [32]
Lorazepam Tablets (0.50 mg/1 mg/2 mg) [37]
Losartan and Hydrochlorothiazide Tablets (50 mg/12.5 mg) [118]
Losartan Potassium Tablets (50 mg) [93]
Mebendazol Tablets (100 mg)
Meclizine Hydrochloride Tablets (25 mg) [135]
Medroxyprogesterone Acetate Tablets (2.5 mg/5 mg/10 mg) [89]
Mefanamic Acid and Dicyclomine Hydrochloride Tablets (250 mg/10 mg)
Mefenamic Acid Tablets (250 mg) . 160
Mefloquine Hydrochloride Tablets (250 mg)
Meprobamate and Phenobarbital Tablets (400 mg/30 mg)
Meprobamate and Phenobarbital Tablets (400 mg/30 mg)
Meprobamate Tablets (400 mg)
Meprobamate Tablets (400 mg)
Metamizol Tablets (500 mg
Metamizol Tablets (500 mg)
Metformin Hydrochloride Tablets, Extended Release (500 mg)
Metformin Tablets (500 mg) [40]
Metformin Tablets, Extended Release (500 mg)
Methenamine Tablets (500 mg)
Methyclothiazide and Deserpidine Tablets (5 mg/0.25 mg)
Methyclothiazide Tablets (5 mg)
Methylergotamine Malate Tablets (0.5 mg)
Methylphenidate Hydrochloride Tablets Extended Release (18 mg/36 mg) [122]
Methylprednisolone Tablets (2 mg/4 mg/8 mg/16 mg/24 mg/32 mg) [99]
Metoclopramide Tablets (10 mg) [138]
Metoclopramide Tablets (20 mg)
Metoprolol Succinate Tablets (95 mg) [21]
Metoprolol Tartrate Tablets [36]
Metronidazole Effervescent Vaginal Tablets (500 mg)
Metronidazole, Furazolidone, and Loperamide Tablets (200 mg/25 mg/2 mg)
Metronidazole Tablets (200 mg)
Metronidazole Tablets (200 mg/400 mg)
Metronidazole Tablets (400 mg) [147]
Metronidazole Tablets (500 mg)
Mirtazapine Tablets [145]
Montelukast Sodium Tablets (5 mg) [54]
Nalidixic Acid Tablets (500 mg)
Nalidixic Acid Tablets (500 mg)
Naproxen Tablets (250 mg) [58]
Naproxen Tablets (250 mg/500 mg)
Naproxen Tablets (450 mg)
Neomycin Tablets (250 mg
Nifedipine Tablets (5 mg)
Nifedipine Tablets (10 mg)
Nimesulide Dispersible Tablets (100 mg)
Nitrendipine Tablets (25 mg)
Nitrofurantoin Tablets (100 mg)
Nitrofurantoin Tablets (100 mg)
Nitroglycerine Tablets (0.3 mg)
Noramidopyrine Methansulfonate and Dicyclomine Hydrochloride Tablets (500 mg/10 mg)
Norethindrone and Ethinyl Estradiol Tablets (0.75 mg/0.035 mg; 0.50 mg/0.035 mg; 1.0 mg/0.035 mg) [131]
Norfloxacin Tablets (400 mg)
Norgestimate and Ethinyl Estradiol Tablets (0.18 mg/0.035 mg; 0.215 mg/0.035; 0.25 mg/0.035 mg) [27]
Nystatin Tablets (50 mg)
Nystatin Tablets (200 mg)
Olanzapine Tablets [110]
Omeprazole and Ibuprofen Tablets (10 mg/400 mg)
Omeprazole Tablets (10 mg/20 mg)
Omeprazole Tablets (10 mg/20 mg)
Omeprazole Tablets, Chewable (10 mg/20 mg)
Omeprazole Tablets, Rapid Dissolution (20 mg)
Oxybutynin Chloride Tablets (5 mg/10 mg) [194]
Oxycodone Hydrochloride and Acetaminophen Tablets (5 mg/325 mg) [90]
Oxycodone Hydrochloride Tablets (5 mg) [119]
Oxytetracycline Tablets (250 mg)
Pantoprazole Tablets [77]
Pantoprozole Tablets (10 mg/20 m 197
Pantoprazole Tablets, Chewable (10 mg/20 mg)
Pantoprazole Tablets, Rapid Dissolution (20 mg)
Para Amino Salicylic Acid Tablets (500 mg)
Paroxetine Hydrochloride Tablets (10 mg/20 mg/30 mg/40 mg) [15]
Penicillin Chewable Tablets (125 mg) [103]
Perfloxacin Tablets (400 mg)
Phendimetrazin Tablets (35 mg)
Phenindion Tablets (50 mg)
Phenoxymethyl Penicillin Potassium Tablets (250 mg)
Phenylbutazone Tablets (100 mg)
Phenylpropanolamine Hydrochloride Tablets (60 mg)
Phenytoin Sodium Tablets (100 mg)
Phenytoin Sodium Tablets (100 mg)
Phenytoin Tablets (100 mg)
Pioglitazone Hydrochloride Tablets (15 mg/30 mg/45 mg) [87]
Pipemidic Acid Tablets (200 mg)
Pipobroman Tablets (25 mg)
Potassium Chloride Tablets (30 mg) [56, 137]
Pravastatin Sodium Tablets (10 to 40 mg) [48]
Prazosin Tablets (5 mg)
Prednisolone Tablets (5 mg)
Prednisolone Tablets (10 mg)
Prednisolone Tablets (20 mg)
Prednisolone Tablets (20 mg)
Prednisone Tablets (10 mg)
Probenecid Tablets (500 mg)
Promethazine Hydrochloride Tablets (10 mg) [107]
Promethazine Hydrochloride Tablets (25 mg)
Propranolol Hydrochloride Tablets (10 mg)
Propranolol Tablets (40 mg)
Propranolol Hydrochloride Tablets (10 mg) [141]
Pyrazinamide Tablets (500 mg)
Pyrazinamide Tablets (500 mg)
Pyrazinamide Tablets (500 mg)
Pyridostigmine Bromide Tablets (10 mg)
Quetiapine Fumarate Tablets (25 mg/100 mg/200 mg) [161]
Quinapril Hydrochloride Tablets (5 mg/10 mg/20 mg/40 mg) [51]
Quinine Sulfate Tablets (300 mg)
Quinolone Antibiotic Tablets (100 mg)
Rabeprazole Sodium Tablets (20 mg) [109]
Raloxifene Tablets (60 mg) [100]
Ranitidine Hydrochloride Tablets (150 mg)
Ranitidine Tablets (75 mg)
Ranitidine Tablets (150 mg) [41]
Ranitidine Tablets (300 mg)
Rifampicin, Isoniazid, Ethambutol, and Pyridoxine Tablets (300 mg/200 mg/25 mg)
Rifampicin Tablets (300 mg)
Rifampicin Tablets (450 mg)
Risedronate Sodium Tablets (5 mg/30 mg) [188]
Risperidone Tablets (4 mg) [1050] . 234
Rofecoxib Tablets (12.5 mg/25 mg/50 mg) [31]
Rosiglitazone Maleate Tablets (2 mg/4 mg/8 mg) [86]
Roxithromycin Dispersible Tablets (200 mg)
Salbutamol Tablets (2 mg)
Salbutamol Tablets (4 mg)
Serratiopeptidase Tablets (10 mg)
Serratiopeptidase Tablets (10 mg)
Sertraline Hydrochloride Tablets (25 mg/50 mg/100 mg) [14]
Sildenafil Tablets (25 mg/50 mg/100 mg) [43]
Silimarin Tablets (35 mg)
Simvastatin Tablets (10 mg) [17]
Simvastatin Tablets (20 mg)
Spironolactone Tablets (25 mg/50 mg/100 mg)) [130]
Stalol Hydrochloride Tablets (500 mg)
Sulfadimidine Tablets (500 mg)
Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg; 800 mg/160 mg; 100 mg/20 mg) ) [106]
Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg)
Sulfamethoxazole and Trimethoprim Tablets (800 mg/160 mg; 400 mg/80 mg)
Sulfamethoxazole and Trimethoprim Tablets, Dispersible (800 mg/160 mg)
Sulfathiazole Tablets (250 mg)
Sumatriptan Succinate Tablets (25 mg/50 mg) [125]
Tamoxifen Tablets (10 mg/20 mg) [191]
Temafloxacin Hydrochloride Tablets (200 mg/300 mg)
Tenoxicam Tablets (20 mg)
Terazosin Tablets (1 mg-10 mg) [126]
Terazosin Tablets (1 mg)
Terbinafine Tablets (250 mg)
Terfenadine Tablets (60 mg)
Tetracycline Tablets (125 mg)
Tetracycline Tablets (250 mg)
Tetrazepam Tablets (50 mg)
Theophylline and Ephedrine Tablets (130 mg/15 mg)
Theophylline Tablets (100 mg)
Theophylline Tablets (100 mg)
Theophylline Tablets CR (200 mg)
Tibolone Tablets (0.3 mg)
Ticlopidine Hydrochloride Tablets (250 mg)
Tolterodine Tablets (1 mg/2 mg) [171]
Topiramate Tablets (100 mg/200 mg) [189]
Tosufloxacin Tosylate Tablets (75 mg)
Trazodone Hydrochloride Tablets (100 mg) [61]
Triamcinolone Tablets (4 mg)
Trifluoperazine Tablets (5 mg)
Tulobuterol Hydrochloride Tablets (1 mg)
Valacyclovir Hydrochloride Tablets (500 mg/1 g) [144]
Valdecoxib Tablets (10 mg/20 mg) [148]
Valproate Sodium Tablets (500 mg) [121]
Valsartan and Hydrochlorothiazide Tablets (80 mg/12.5 mg; 160 mg/25 mg) [108]
Venlafaxine Hydrochloride Tablets (25 mg/37.5 mg/50 mg) [53]
Verapamil Tablets (120 mg) [65]
Warfarin Tablets (1, 2, 2.5, 3, 4, 5, 6, 7.5, and 10 mg) [59]
Zolpidem Tartrate Tablets (5 mg/10 mg) [35]

Coating Solutions
I. Introduction
II. Hydroxypropyl Methylcellulose (Methocel, HPMC) Aqueous Coatings III. Hydroxypropyl Methylcellulose Opaque Organic Coating IV. Hydroxypropyl Methyl Cellulose-Hydroxypropyl Cellulose (Klucel) Coating V. Hydroxypropyl Methylcellulose-Ethylcellulose Coating VI. Hydroxymethyl Cellulose and Hydroxy Cellulose Coating VII. Hydroxymethyl Cellulose and Ethyl Cellulose Coating VIII. Polyvinylpyrrolidone Coatings IX. Cellulose Acetate Phthalate and Carbowax Coatings XI. Enteric Coatings