Dermatological preparations for the tropics

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1 > * "» ' ' * ' * * '? *! =. *. * * -!! * * " * ' Dermatological preparations for the tropics J!»' % *; I,/,- * ""*'' ""'"" *'' ' : * - * ' * * f V * *? ' * S 3. '. s,,*,., «., - ; * (- J ; *;;; I r "*» f i '> i Reter Bakker ; '; Han^^ah Doorh^ JViricent Gooskens Nicolien Wieringa

2 Table of contents Preface Part I: A formulary of dermatological preparations 1 General notes 1 amounts to be prepared 2 quality assurance 3 amounts to be supplied 4 packaging 5 labelling 6 storage 7 stock control 8 safety precautions 9 temperatures 10 weights and measures 2 Basic standards of good manufacturing practice for local production units in the tropics 1 personnel 2 hygiene 3 premises 4 equipment 5 manufacturing procedures 5.1 large scale production 5.2 extemporaneous preparation and dispensing 3 Basic methods. 1 weighing 1.1 weighing with a double pan balance 1.2 weighing with a single pan balance 2 measurement of liquids 2.1 measurement with measures 2.2 measurement with pipettes 2.3 measurement with a dropper 3 making up to volume or weight 3.1 making up to volume 3.2 making up to weight 4 size reduction and sieving of solids 4.1 grinding before mixing 4.2 grinding during mixing 4.3 sieving

3 5 mixing of ingredients mixing of miscible liquids 5.2 dissolving a solid in a liquid 5.3 mixing of solids 5.4 mixing a solid with a semisolid 5.5 mixing of fatty substances 5.6 mixing a liquid and a semisolid 6 heating 30 7 sterilization 30 4 Indications for included preparations 33 5 Preparations 35 Basic cream 37 Benzylbenzoate emulsion 39 Calamine lotion> (modified) 41 Chlorhexidine diacetate solution 1% 43 Chlorhexidine digluconate solution 1% 45 Dithranol cream 47 Dithranol paste 50 Emulsifying ointment 52 Gentianviolet solution 54 Hydrocortisone cream 56 Hydrocortisone ointment 58 Industrial methylated spirit 70% " 60 Iodine solution 62 Iodine tincture 64 Lindane cream 66 Miconazole cream. 69 Nystatin preparations 70 Para aminobenzoic acid cream 71 Para aminobenzoic acid solution 73 Petrolatum 75 Potassium permanganate solution for dilution 76 Salicylic acid ointment 78 Salicylic acid solution 80 Silver nitrate solution 82 Silversulphadiazine cream 84 Sodium thiosulphate 86 Strong corticosteroid preparation 88 Sulphur cream 90 Sulphur lotion 92 Sulphur ointment 94 Tar cream 96 Tar paste 98 Tar solution 100 Urea cream 102 Urea ointment 104 Water 106 Whitfield's cream 107 Whitfield's ointment 109 Zinc oil 112 Zinc paste 114

4 6 Raw materials 117 Aluminium magnesium silicate 118 Ascorbic acid 118 Bentonite 118 Benzoic acid 119 Benzylbenzoate 119 Calamine 119 Chlorhexidine diacetate 120 Chlorhexidine digluconate stock solution 20% 120 Coal tar 121 Dithranol 121 Gentianviolet 122 Glycerin 122 Hydrocortisone acetate 123 Industrial methylated spirit 123 Iodine ' 124 Lanette wax 124 Lindane 125 Liquid paraffin 125 Liquified phenol 126 Methylparaben 127 Para aminobenzoic acid 127 Petrolatum 127 Phenol Polysorbate Potassium iodide 129 Potassium permanganate 129 Salicylic acid 130 Silver nitrate 130 Sodium iodide 131 Sodium thiosulphate 131 Sulphur 132 Trisodium citrate 132 Urea 133 Vegetable oil 133 Water 134 Zinc oxide Vocabulary Synonyms of preparations, and raw materials 139 Part II: Backgrounds of choices, formulation and dispensing 9 Introduction: dermatological preparations for the tropics 1 history of the project 2 Alma Ata and primary health care 3 essential drugs 4 local production of drugs 5 basic needs 6 conclusions 7 criteria 8 literature

5 10 Dermatological therapy in tropical Third World countries drugs for use in infectious diseases bacterial diseases antimicrobial treatment antibiotics antiseptics conclusions treatment of burns available preparations conclusions treatment of ulcers in leprosy mycotic skin infections available antimycotics conclusion scabies and other parasitic skin diseases scabicides conclusions literature 1.7 corticosteroids side effects weak and strong corticosteroids selecting a corticosteroid literature astringents keratoplastic and keratolytic agents, moisturizers and antimitotics keratoplastic and keratolytic agents 4.3 moisturizers 4.4 management of dry skin in lepros 4.5 antimitotics 4.6 conclusions 4.7 literature antipruritics "indifferent" vehicles sunscreen agents general literature to chapter Dermatological preparations for tropical use ointments gels 1.3 petrolatum ceresin 1.4 cetostearyl alcohol polymorphism of cetostearyl alcohol other gel forming emulsifiers water and cetostearyl alcohol 1.5 plastibase 1.6 inorganic gelling agents 1.7 other fatty ointment bases 1.8 microbiological problems with fatty ointments? 1.9 conclusions 1.10 literature

6 pastes zinc paste 2.3 zinc oil 2.4 preparation techniques 2.5 literature creams the cream system the oil phase the water phase emulsifier preservation inactivation of preservatives side effects due to preservatives 3.6/3 the choice of a preservative preparation methods conclusions literature shake lotions literature composition of calamine lotion sedimentation preservation conclusion 5 general literature to chapter Stability of drugs chemical stability: reaction kinetics 1.2 chemical stability: shelf life 1.3 physical instability of raw materials 1.4 microbiological stability 1.5 package and stability 1.6 literature 2 hydrolysis of benzoic acid esters reaction mechanism 2.3 stability of the parabens 2.4 stability of benzylbenzoate 2.5 literature 3 stability of chlorhexidine in solutions degradation products 3.3 reaction kinetics 3.4 literature 4 stability and formulation of dithranol reaction mechanism 4.3 reaction kinetics 4.4 stability of dithranol in preparations 4.5 literature

7 10 5 stability of hydrocortisone and other corticosteroids corticosteroid degradation degradation products degradation kinetics stability of hydrocortisone in some preparations 5.3 ester hydrolysis 5.4 acetonides 5.5 conclusions 5.6 literature 6 stability of phenolic compounds degradation of phenols 6.3 literature 7 stability of sorbic acid in solutions physical stability 7.3 degradation reactions 7.4 degradation kinetics 7.5 conclusions 7.6 literature 8 stability of urea degradation of urea 8.3 conclusions 8.4 literature 9 summary of stability data general literature to chapter Addendum A In-vitro activity of gentianviolet 209 Addendum B Sedimentation of modified calamine lotion 212 Addendum C Preservation of modified calamine lotion Index 215

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