Pharmaceutical Compounding and Dispensing - Pharmaceutics

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Storage and labelling requirements Storage All products dispensed extemporaneously require some form of additional storage instructions to be detailed on the label. This information can be the addition of just a product expiry date through to a number of important additional auxiliary labels. The summary list given in Table 1.1 is to be used as a guide in the absence of any guidance from the offi cial pharmaceutical texts. It should be remembered that the information in this table is to be used only as a guide. Any information on additional labelling or expiry dates in the offi cial texts will supersede the information provided in Table 1.1. All suggested expiry dates included in Table 1.1 and other sections of this book are to be used as a guide only and are based on historical practice. General principles of labelling Every extemporaneously prepared preparation will require a label to be produced before the product can be dispensed or sold to the patient. The accuracy of the label is paramount as it conveys essential information to the patient on the use of the preparation. Although the pharmacist or other healthcare practitioner may counsel patients when the medication is handed over, it is unlikely that patients will be able to remember all the information that they are given verbally. The label therefore acts as a permanent reminder of the key points that patients need to know. Table 1.1 A guide to auxiliary labels and discard dates for extemporaneous preparations. Introduction 3 Tips Nowadays it is common practice to assign a maximum of a 2-week discard to any extemporaneously prepared product. Consideration should always be given to assigning a shorter discard date. KeyPoints The label of a pharmaceutical product has many functions: To indicate clearly the contents of the container To indicate clearly to patients how and when the medicinal product should be taken or used To indicate clearly to patients how the product should be stored and for how long To indicate clearly to patients any warnings or cautions of which they need to be made aware. Preparation Container Important auxiliary labels Suggested discard date Applications Amber fl uted bottle with CRC For external use only 4 weeks Capsules Amber tablet bottle See BNF for advisory labels 3 months with CRC recommended for active ingredient Creams Amber glass jar or For external use only 4 weeks and Gels collapsible metal tube
4 Pharmaceutical Compounding and Dispensing Preparation Container Important auxiliary labels Suggested discard date Dusting Plastic jar preferably For external use only 3 months Powders with a perforated, Not to be applied reclosable lid to open wounds or raw weeping surfaces Store in a dry place Ear Drops Hexagonal amber fl uted glass bottle with a rubber teat and dropper closure For external use only 4 weeks Elixirs Plain amber medicine bottle with CRC 4 weeks Emulsions Plain amber medicine Shake the bottle bottle with CRC 4 weeks Enemas Amber fl uted bottle For rectal use only* 4 weeks with CRC Warm to body temperature before use Gargles and Amber fl uted bottle Not to be taken* 4 weeks Mouthwashes with CRC Do not swallow in large amounts Inhalations Amber fl uted bottle Not to be taken* 4 weeks with CRC Shake the bottle Linctuses Plain amber medicine bottle with CRC 4 weeks Liniments Amber fl uted bottle For external use only 4 weeks and Lotions with CRC Shake the bottle Avoid broken skin Mixtures and Plain amber medicine Shake the bottle 4 weeks Suspensions bottle with CRC Nasal Drops Hexagonal amber fl uted glass bottle with a rubber teat and dropper closure Not to be taken* 4 weeks Ointments Amber glass jar For external use only 3 months Pastes Amber glass jar For external use only 3 months Pessaries Wrapped in foil and packed in an amber glass jar For vaginal use only* 3 months Powders Wrapped in powder Store in a dry place 3 months (individual) papers and packed in Dissolve or mix with a cardboard carton water before taking See BNF for advisory labels recommended for active ingredient Suppositories Wrapped in foil and For rectal use only* 3 months packed in an amber See BNF for advisory glass jar labels recommended for active ingredient BNF – British National Formulary; CRC – Child Resistant Closure * – See General principles of labelling below
Page 1 and 2: Pharmaceutical Compounding and Disp
Page 4 and 5: Pharmaceutical Compounding and Disp
Page 6: Contents Introduction to the FASTtr
Page 9 and 10: viii Preface This book has been wri
Page 12 and 13: chapter 1 Introduction Layout of th
Page 16 and 17: Appearance Correct position - Medi
Page 18 and 19: intended for internal use, this is
Page 20 and 21: pharmaceutical dosage forms. As it
Page 22 and 23: Medical bottles Plain amber medicin
Page 24 and 25: Figure 1.4 A selection of conical m
Page 26 and 27: scale manufacturing environments wh
Page 28 and 29: chapter 2 Solutions Overview Upon c
Page 30 and 31: Figure 2.1 A porcelain mortar and p
Page 32 and 33: The following method would be used
Page 34 and 35: measure and add to the Sodium Bicar
Page 36 and 37: d. Flavouring when appropriate Liqu
Page 38 and 39: 1. Use of the product Used as a mou
Page 40 and 41: The fi nal volume of Sodium Chlorid
Page 42 and 43: Patient: Mr Gary Murray, 12 Bishop
Page 44 and 45: c. Product-specifi c cautions (or a
Page 46 and 47: Solutions 4. A paediatric vitamin d
Page 48 and 49: 13. How much solid would be require
Page 50 and 51: Questions 23. How many millilitres
Page 52 and 53: Solutions 31. The molecular weight
Page 54 and 55: chapter 3 Suspensions Overview Upon
Page 56 and 57: 3. Prepare any Double Strength Chlo
Page 58 and 59: 2. Is it safe and suitable for the
Page 60 and 61: ensure that only the correct amount
Page 62 and 63: Example 3.2 The preparation of Paed
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9. Add the Syrup BP to the mortar a
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Product formula (from the British P
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7. Advice to patient The patient wo
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5. Transfer the tablets to a glass
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Self-assessment Questions 1. Distin
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Formulation questions This section
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66 Pharmaceutical Compounding and D
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chapter 5 Creams Overview Upon comp
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Figure 5.1 A water bath and heater.
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Worked examples Example 5.1 The pre
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. Quantitative particulars Quantita
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5. Choice of container A collapsibl
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Product formula Master 100 g 10 g 6
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3. How many grams of Eumovate Cream
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13. You receive a prescription in y
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108 Pharmaceutical Compounding and
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chapter 7 Suppositories and pessari
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Worked examples Example 7.1 Calibra
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Patient: Master Roger Carlson, 21 H
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Suppositories BP as they are availa
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Method of preparation of Ichthammol
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Bismuth Subgallate BP displaces 2
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f. Discard date The products are su
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8. You receive a prescription in yo
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Answers to self-assessment Chapter
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Answers to self-assessment 29. 1 li
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Answers to self-assessment 34. Hibi
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Answers to self-assessment 9. Quant
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Answers to self-assessment dissolut
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Answers to self-assessment The foll
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12. Peppermint Oil BP is a volatile
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Answers to self-assessment 11. Make
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Answers to self-assessment Chlorofo
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9. Answer: d (‘Apply liberally as
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the same/similar proportions (Briti
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Answers to self-assessment 9. Answe
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Answers to self-assessment 1. Weigh
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Formula For 1 suppository For 10 su
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Calculations Six suppositories are
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5. The prescription requests two ca
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. Quantitative particulars are requ
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Bibliography British National Formu
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Appendices Appendix 1 Glossary of t
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Powder A preparation consisting of
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pess pessus pessary pig pigmentum a
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Index abbreviations, 205-7 Acacia B
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labelling, 3 preparation, terminolo
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advantages/disadvantages, 18 basic
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