Handbook of

Extemporaneous
A guide to pharmaceutical
compounding

Edited by
M a r k Jackson BSC, MPhii, MRPharms
Deputy Director, QCNW/Head of QA/QC, Liverpool Pharmacy Practice Unit,
Liverpool, UK

A n d r e w LOWey DPharm, MRPharmS

Clinical Pharmacy Manager, Leeds Teaching Hospitals, Leeds, UK

On behalf of
The NHS Pharmaceutical Quality Assurance Committee

London Chicago

(RP)
Pharmaceutical Press

Contents

Preface
About the editors
Membership of the editorial board
Acknowledgements

PartA Standards
1
2
3
4
5
6
7
8
9
10
11
12

Introduction
Risk management
Quality management
Personnel and training
Premises and equipment
Documentation
Preparation
Formulation and stability
Quality control
Complaints, product recalls and adverse events
Procurement and quality assessment of extemporaneously
prepared medicines
Audit and monitoring

Part B Extemporaneous preparation formulary

13
14

Introduction
Formulary of extemporaneous preparations

viii
xi
xiii
xiv

1
3
11
23
27
31
35
41
47
55
59
61
65

67
69
87

Acetazolamide oral liquid

89

Allopurinol oral liquid

96

Amiodarone hydrochloride oral liquid

103

L-Arginine hydrochloride oral liquid

110

Azathioprine oral liquid

113

Bendroflumethiazide oral liquid

120

Captopril oral liquid

125

Clobazam oral liquid

134

Clonidine hydrochloride oral liquid

138
144

Clozapine oral liquid

150

Co-careldopa oral liquid (levodopa and carbidopa)

158

Co-enzyme Q10 oral liquid

166

Clonazepam oral liquid

Dexamethasone oral liquid and dexamethasone sodium

phosphate oral liquid

171

Diazoxide oral liquid

178

Dinoprostone (prostaglandin E2) oral liquid

183

Ergocalciferol oral liquid

189

Ethambutol hydrochloride oral liquid

194

Gabapentin oral liquid

200

Gliclazide oral liquid

205

Hydrocortisone oral liquid

209

Indometacin (indomethacin) oral liquid

217

Isosorbide mononitrate oral liquid

227

Joulie's solution (oral phosphate Supplement)

231
237

Knox mouthwash
Levothyroxine sodium oral liquid

243

Lorazepam oral liquid

Magnesium glycerophosphate oral liquid
Menadiol sodium phosphate oral liquid

255
264

Metformin hydrochloride oral liquid

272

Midazolam hydrochloride oral liquid

276

Morphine sulfate oral liquid

288

Omeprazole oral liquid

300

Phenobarbital and phenobarbital sodium oral liquid

Phenoxybenzamine hydrochloride oral liquid

315
329
336

Potassium acid phosphate oral liquid

Primidone oral liquid
Pyrazinamide oral liquid

268

339
344

Pyridoxine hydrochloride (vitamin B6) oral liquid

Quinine sulfate oral liquid
Sildenafil citrate oral liquid

351

Sodium bicarbonate oral liquid

Sodium Chloride oral solution

368

357
363
373

Sodium phenylbutyrate oral liquid

St Mark's solution

380

Tacrolimus oral mouthwash

383

Tacrolimus oral Suspension

387

Thiamine hydrochloride oral liquid

396

Tranexamic acid oral mouthwash

404

Vancomycin hydrochloride oral liquid

Warfarin sodium oral liquid

408

377

417

Appendix 1: Change control request form

425

Appendix 2: Deviation reporting form

427

Appendix 3: Example raw material specification

429

Appendix 4: Example worksheet

431

Appendix 5: Technical agreement for commissioning

of extemporaneous product preparation service

433

Appendix 6: Audit tool for extemporaneous preparation

437

Appendix 7: Suspending agents

445

Glossary

447

Index

449