Extemporaneous FORMULATION - Pharmacy
PHARMACEUTICAL SERVICES DIVISIONMinistry of Health MalaysiaExtemporaneousFORMULATIONPharmaceutical Services DivisionMinistry of Health MalaysiaLot 36, Jalan Universiti,46350 Petaling Jaya, Selangor.Tel: 03-78413200 Fax: 03-79682222/79682268
Extemporaneous Formulation, MOH 2015Pharmaceutical Services Division,Ministry of Health MalaysiaLot 36, Jalan Universiti,46350 Petaling Jaya, Selangor.Previous edition was Extemporaneous Formulary MOH 2012.ALL RIGHTS RESERVEDNo part of this publication may be reproduced, stored or transmitted in any form or by any meanswhether electronic, mechanical, photocopying, tape, recording or other without permissionfrom the Senior Director of Pharmaceutical Services, Ministry of Health Malaysia.Perpustakaan Negara MalaysiaExtemporaneous Formulation, Ministry of Health Malaysia.
PHARMACEUTICAL SERVICES DIVISIONMinistry of Health MalaysiaExtemporaneousFORMULATION
EDITORIAL BOARDPatronAbida Haq binti Syed M. HaqDirector of Pharmacy Practice & Development,Pharmaceutical Services Division, MOHAdvisorRosminah binti Mohd DinPharmaceutical Services Division, MOHEditorsNurul Adha binti OthmanPharmaceutical Services Division, MOHRabi’ah binti MamatHospital SelayangNoor Liyana YusupPharmaceutical Services Division, MOHContributorsNoor Haslina binti Othman - Hospital Raja Prempuan Zainab IINik Nuradlina binti Nik Adnan - Institut Kanser NegaraChan May Yee - Hospital Kuala LumpurChuo Sing Hong - Hospital SibuCynthia Hee Xiao Ying - Hospital Pulau PinangDarshini Siwanandan - Hospital Sungai BulohJanice Lee Siaw Vun - Hospital Wanita & Kanak-Kanak SabahKhoo Sze Ni - Hospital Raja Permaisuri BainunNg See Yee - Hospital Sultanah BahiyahZaitun binti Mohd Saman - Hospital Pakar Sultanah FatimahAsmahani Ramelan - Hospital Tengku Ampuan Rahimah, KlangTeoh Ai Luan - Hospital Pulau PinangAzhani Kamarudin - Hospital Sungai BulohNabilah Mohamad Shohaime - Hospital PutrajayaGurvinderjit Kaur - Hospital Kuala Lumpur
CONTENTSINTRODUCTION. 1OBJECTIVE. 1POLICY. 2CONSIDERATIONS FOR PREPARING EXTEMPORANEOUS COMPOUNDS. 3WORK FLOW CHART 1: SOURCING THE COMPOUNDING FORMULARY LIST OFEXTEMPORANEOUS PREPARATION MEDICINES. 5CHECKLIST 1: SOURCING THE COMPOUNDING FORMULARY LIST OF EXTEMPORANEOUSPREPARATION MEDICINES. 6WORK FLOW CHART 2: HANDLING OF PRESCRIPTIONS WITH EXTEMPORANEOUSPREPARATION MEDICINES IN THE PHARMACY. 7STANDARD LABEL DESIGN & WORKSHEET REQUIREMENTS FOR EXTEMPORANEOUSPREPARATIONS. 8CHECKLIST 2: HANDLING OF PRESCRIPTIONS WITH EXTEMPORANEOUS PREPARATIONMEDICINES IN THE PHARMACY. 91. ACETAZOLAMIDE SUSPENSION 25MG/ML. 102. ALLOPURINOL SUSPENSION 20MG/ML. 113. ALPRAZOLAM SUSPENSION 1MG/ML. 124. AMIODARONE SUSPENSION 40MG/ML. 135. AMLODIPINE SUSPENSION 1MG/ML. 146. ATENOLOL SUSPENSION 2MG/ML. 157. BACLOFEN SUSPENSION 5MG/ML. 168. BACLOFEN SUSPENSION 10MG/ML. 179. CAFFEINE CITRATE SOLUTION 10MG/ML. 1810. CAPTOPRIL SYRUP 1MG/ML. 1911. CAPTOPRIL SOLUTION 1MG/ML. 2012. CARBIDOPA/LEVODOPA (SINEMET ) SUSPENSION 1.25MG CARBIDOPA/5MGLEVODOPA/ML. 2113. CARVEDILOL SUSPENSION 0.5MG/ML. 2214. CARVEDILOL SUSPENSION 1MG/ML. 2315. CHLOROQUINE SUSPENSION 15MG/ML. 2416. CITRIC ACID 25%. 2517. CLONAZEPAM SUSPENSION 0.1MG/ML. 2618. CLOPIDOGREL SUSPENSION 5MG/ML. 2719. DAPSONE SUSPENSION 2MG/ML. 2820. DEXAMETHASONE SUSPENSION 0.5MG/ML. 2921. DIPYRIDAMOLE SUSPENSION 10MG/ML. 3022. ENALAPRIL SUSPENSION 0.1MG/ML. 3123. ENALAPRIL SUSPENSION 1MG/ML. 3224. FERRIC AMMONIUM CITRATE 400MG/5ML MIXTURE. 33
25. FOLIC ACID SUSPENSION 1MG/ML. 3426. GABAPENTIN SUSPENSION 100MG/ML. 3527. GLYCOPYRROLATE SYRUP 0.1MG/ML. 3628. HYDROCHOLOROTHIAZIDE SUSPENSION 5MG/ML. 3729. INDOMETHACIN SYRUP 5MG/ML. 3830. ISONIAZID SYRUP 10MG/ML. 3931. LABETALOL SYRUP 10MG/ML. 4032. LABETALOL SYRUP 40MG/ML. 4133. LANSOPRAZOLE SUSPENSION 3MG/ML. 4234. LORAZEPAM SYRUP 0.4MG/ML. 4335. METHYLCELLULOSE SUSPENDING AGENT 1% (0.01G/ML). 4436. METOPROLOL SUSPENSION 10MG/ML. 4537. MIDAZOLAM SYRUP 2MG/ML. 4638. NIFEDIPINE SUSPENSION 1MG/ML. 4739. NIFEDIPINE SUSPENSION 4MG/ML. 4840. NITROFURANTOIN SUSPENSION 10MG/ML. 4941. OMEPRAZOLE SUSPENSION 2MG/ML. 5042. PANTOPRAZOLE 2MG/ML. 5143. PENTOXIFYLLINE SOLUTION 20MG/ML. 5244. PHENOBARBITONE SUSPENSION 10MG/ML. 5345. PHYTOMENADIONE (VITAMIN K1) LIQUID 1MG/ML. 5446. PROPRANOLOL SUSPENSION 0.5MG/ML. 5547. PROPRANOLOL SUSPENSION 1MG/ML. 5648. PYRAZINAMIDE SUSPENSION 10MG/ML. 5749. PYRAZINAMIDE SYRUP 100MG/ML. 5850. RIFAMPICIN SYRUP 10MG/ML. 5951. RIFAMPICIN SUSPENSION 25MG/ML. 6052. SILDENAFIL SUSPENSION 2.5MG/ML. 6153. SPIRONOLACTONE SYRUP 1.25MG/ML. 6254. SPIRONOLACTONE SYRUP 2.5MG/ML. 6355. TRIMETHOPRIM SUSPENSION 10MG/ML. 6456. TRIMETHOPRIM SYRUP 10MG/ML. 6557. URSODEOXYCHOLIC ACID SUSPENSION 50MG/ML. 6658. VERAPAMIL SUSPENSION 50MG/ML. 6759. VERAPAMIL SUSPENSION 8MG/ML. 68ABBREVIATIONS. 69
INTRODUCTIONCompounding of pharmaceutical formulations remain as the core skill ofpharmacists and this manual is produced to include well referenced recipesthat are easy to prepare, use readily available ingredients, have the longestexpiry date possible and when necessary, provide more than one strength offormulation to accommodate the unique needs of different groups of patients.Efforts have been made to search for substantiated references in producing thismanual of extemporaneous preparations. However, the lists of compoundeditems in this manual are not exhaustive. Preparations included in the manualare for ingredients available commercially but not in the required dosageform for therapy and thus, necessitate extemporaneous preparations.The committee has made all reasonable efforts to confirm the accuracy ofthe information contained in the manual and to present the best practices asidentified at the time of its completion. Formulations are only included wherethere is existence of published formulations and associated stability data.The use of this manual requires knowledge based interpretation by healthcareprofessionals and is intended solely for use by pharmacists in healthcarefacilities. All information contained in the manual has been provided with thesole intention that it be readily accessible for pharmacist’s information and asa guide for preparing extemporaneous preparations that may be prescribed.OBJECTIVETo standardise formulations of extemporaneous preparations and practice inhealthcare facilities.1
POLICY1. Always consider the use of commercially available products as far aspossible.2. If no suitable commercial product exists, consider a therapeuticalternative that is available in a suitable dosage form. This must bediscussed with the physician.3. Extemporaneous preparations should be done based on evidence-basedreferences.4. Always check for the suitability of the product/brand for extemporaneouspreparations.5. Preparations listed in this manual should be done according to what isstated as far as possible unless stated otherwise in the product leaflet.6. When no information is available, compound an oral medication bydispensing a tablet and/or capsule and directing the caregiver to mix justprior to administration.7. Stability stated in this manual is applicable for shelf storage in the pharmacywithout opening. Once opened, the stability of the preparation shouldbe no longer than 30 days. Maximum quantity of the extemporaneouspreparations to be dispensed should not exceed one month.8. Refrain assumptions on the therapeutic equivalence in the case ofsuggesting alternative agents as the possibilities and supporting datamay be limited.9. Techniques in compounding preparations and manipulations shouldalways be in line with the standard Good Preparation Practice as deliveringan accurate dose is paramount.10. Staff and facilities are challenged to undertake intermittent competencyassessments in order to achieve the standards requirement.11. Documentation after each preparation should include details on thematerials used, processes involved and the responsible personnel incharge.2
CONSIDERATIONS FOR PREPARING EXTEMPORANEOUS COMPOUNDS1. Pharmacy personnel are reminded not to empirically change flavouringsor suspending agents because they can affect the pH and stability of theproduct and result in an unstable product.2. Please consider ingredients in the formulations that require specialprecautions in neonates.3. Mixing of a compounded formulation should always be in line with thefollowing principles:a. Ensure that all ingredients used are within the expiry date.b. Ensure that all utensils are clean; including mortar and pestle,graduates, pill cutters and stirring rods.c. Product should be labelled clearly and stored as recommendedwithin the formula.d. For solution or suspension products, emphasise on the importanceof thorough shaking before administration.4.5.6.If compounding a preparation using contents from an ampoule,remember to withdraw the solution (medication) from the ampouleusing a filter needle to ensure no glass particles are incorporated intothe compound.Place tablet(s) within mortar and pestle to grind tablets to a fine powder.For film-coated tablets, it may be necessary to add a small amount ofdiluents such as water, to soften the coating prior to grinding the tablets.This will ensure that the compound will not have an eggshell appearancefrom the film coating floating throughout the suspension. If you are usingcapsules, open the capsule and empty the powder into the mortar anddiscard the capsule shell.Solutions will have a clearer appearance versus a compoundedsuspension.3
7.8.9.4Manipulations of the available dosage forms in order to fulfil theunusual practitioner’s request may impose risks such as preparationand administration errors as well as unpredictable bioavailability,compatibility and stability profile.Understand the roles of excipients in certain formulations and considertheir risks over benefits limitation.If distilled water is not available, water for injection can be used as asubstitution, and vice versa.
WORK FLOW CHART 1:SOURCING THE COMPOUNDING FORMULARY LIST OFEXTEMPORANEOUS PREPARATION MEDICINESIdentify list of extemporaneousmedicines currently being usedDo not proceedNOCheck appropriatenessof medicineYESGet company/manufacturer toregister/produceNOCheck registrationstatusYESApply to get in into theFUKKM list if usedextensivelyNODetermine FUKKMstatusYESPrepare and dispenseextemporaneousmedicineNOCheck commercialavailabilityYESPrepare and dispenseextemporaneousmedicineCheck cost of commercialproduct versus cost ofpreparing medicineNOYESPropose hospitalto purchase5
CHECKLIST 1:SOURCING THE COMPOUNDING FORMULARY LIST OFEXTEMPORANEOUS PREPARATION MEDICINESNO6ACTION1.Identify list of extemporaneousmedicines currently being used2.Check appropriateness of medicine3.Check registration status4.Determine FUKKM status5.Check commercial availability6.Check cost of commercial productversus cost of preparing medicine7.Propose hospital to purchaseTICK ( )NOTE
WORK FLOW CHART 2:HANDLING OF PRESCRIPTIONS WITH EXTEMPORANEOUSPREPARATION MEDICINES IN THE PHARMACYReceiveprescriptionDispenseYESCheck availability of medicinein pharmacyNODispensealternativemedicineYESDiscuss with medicalpractitioner on alternativemedicineNOObtain anddispense within24 hoursYESCheck commercially availablestatus at pharmacy retail outletNOPrepare and dispenseextemporaneousmedicineSearch for evidence-basedreference / product leaflet toprepare extemporaneousmedicineYESNOInstruct patient on how to prepareprior to administration, if need toprepare stat each timeDispense tablet / capsule andcounsel patient accordingly7
STANDARD LABEL DESIGN &WORKSHEET REQUIREMENTS FOR EXTEMPORANEOUSPREPARATIONSThe proposed label for extemporaneous preparations must have theinformation as shown below:Details ofHospital/KlinikKesihatanHOSPITAL/KLINIK KESIHATANJalan Alamat 1, Poskod 12345 Daerah, NegeriTel: 03-9876 5432Nama:Minum:PagiExpiryDateR/N:Tarikh:Details ofPatientmL setiap hariTengahariPetangSebelum makanBersama/selepas makanMalamApabila perluSetiap jamAdministrationInstructionsARAHAN: Goncang botol sebelum gunaSimpan di peti sejuk (2-8ºC)Simpan pada suhu bilikGUNA SEBELUM:NAMA UBAT:Drug’sName withStrengthUBAT TERKAWALJAUHI DARIPADA KANAK-KANAKThe worksheet of the product should contain the following details: Patient’s name ID number Prescription number Date of preparation Name of drug Dose Volume of diluent/vehicle Batch number of preparations & starting materials Name and signature of preparing personnel Name and signature of checking personnel8
CHECKLIST 2:HANDLING OF PRESCRIPTIONS WITH EXTEMPORANEOUSPREPARATION MEDICINES IN THE PHARMACYNOACTION1.Receive prescription2.Check availability of medicine3.Discuss with medical practitioneron alternative medicine4.Check commercially availablestatus at retail pharmacy outlet5.Search for evidence-based referenceto prepare extemporaneousmedicine6.Instruct patient/caregiver on howto prepare prior to administrationof medicine, if needed to preparestat each time7.Dispense medicine and counselpatient/caregiver accordinglyTICK ( )NOTE9
1. ACETAZOLAMIDE SUSPENSION 25MG/MLGeneric NameIndicationDosage deVehicle: Acetazolamide: Reduction of intra-ocular pressure in open-angle glaucoma,secondary glaucoma and peri-operatively in angle-closureglaucoma: Suspension: 25mg/mL: 60 days: Refrigerate (preferable) or at room temperatureSTRENGTHQUANTITY250mg12 tabletsqs120mLVEHICLE OF CHOICE: Ora-Sweet : Ora-Plus (1:1) or Ora-Sweet SF : Ora-Plus (1:1) or Ora-Blend SF or Cherry syrup or Equivalent vehicle to Ora-Sweet : Ora-Plus (1:1)PROCEDURE:1. Crush tablets in a mortar to fine powder.2. Levigate the powder with small amount of vehicle until smooth paste is formed.3. Add more vehicle to the paste until liquid is formed and transfer the liquid into acontainer.4. Use additional vehicle to rinse the remaining drug from the mortar and pour intothe container.5. Make up to final volume with vehicle.6. Shake well and label.NOTES:REFERENCES:1. Allen LV, Erickson MA.(1996) Stability of acetazolamide allopurinol, azathioprine,clonazepam, and flucytosine in extemporaneously compounded oral liquids. Am J HealthSys Pharm. 53:1944.10
2. ALLOPURINOL SUSPENSION 20MG/MLGeneric NameIndicationDosage Vehicle::::::AllopurinolGout or uric acid and calcium oxalate renal stonesSuspension20mg/mL60 daysRefrigerate (preferable) or at room temperatureSTRENGTHQUANTITY300mg8 tabletsqs120mLVEHICLE OF CHOICE: Ora-Sweet : Ora-Plus (1:1) or Ora-Sweet SF : Ora-Plus (1:1) or Ora-Blend or Ora-Blend SF or Cherry syrup or Equivalent vehicle to Ora-Sweet : Ora-Plus (1:1) Methylcellulose 1% : Simple Syrup (1:1)PROCEDURE:1. Crush tablets in a mortar to fine powder.2. Levigate the powder with small amount of vehicle until smooth paste is formed.3. Add more vehicle to the paste until liquid is formed and transfer the liquid into acontainer.4. Use additional vehicle to rinse the remaining drug from the mortar and pour intothe container.5. Make up to final volume with vehicle.6. Shake well and label.NOTES:REFERENCES:1. Allen LV and Erickson MA. Stability of Acetazolamide, Allopurinol, Azathioprine,Clonazepam, and Flucytosine in Extemporaneously Compounded Oral Liquids. Am JHealth Sys Pharm 1996;53:1944-9.2. Dressman JB and Poust RI. Stability of Allopurinol and five antineoplastics in suspension.Am J Hosp Pharm 1983; 40 (4): 616-8.11
3. ALPRAZOLAM SUSPENSION 1MG/MLGeneric NameIndicationDosage zolamAnxiety disordersSuspension1mg/mL60 daysRoom temperature and protect from lightSTRENGTHQUANTITY1mg60 tabletsqs60mLAlprazolamVehicleVEHICLE OF CHOICE: X-Temp Oral Suspension SystemPROCEDURE:1. Crush tablets in a mortar to fine powder.2. Levigate the powder with small amount of vehicle until smooth paste is formed.3. Add more vehicle to the paste until liquid is formed and transfer the liquid into acontainer.4. Use additional vehicle to rinse the remaining drug from the mortar and pour intothe container.5. Make up to final volume with vehicle.6. Shake well and label.NOTES:REFERENCES:1. X-Temp Oral Suspension System. Master Formulation Sheets 2013.2. Pharmacy Compounding Manual 2008, Calgary Health Region Pharmacy.12
4. AMIODARONE SUSPENSION 40MG/MLGeneric NameIndicationDosage aroneAmiodaroneArrhythmiasSuspension40mg/mL28 daysRoom temperature and protect from lightSTRENGTHQUANTITY200mg20 tablets- 10mLqs100mLSodium BicarbonateVehicleVEHICLE OF CHOICE: X-Temp Oral Suspension SystemPROCEDURE:1. Measure out the vehicle and adjust the pH to pH 6-7 using Sodium Bicarbonate5% solution.2. Grind the tablets to fine powder in a mortar and levigate the powder using asmall amount of vehicle (pH adjusted) to form smooth paste.3. Gradually add the vehicle (pH adjusted) in small amounts to the paste, mix welluntil liquid is formed and transfer into a container.4. Use additional vehicle to rinse the remaining drug from the mortar and add tothe container.5. Make up the final volume using more vehicle (pH adjusted) and stir well.6. Shake well and label.NOTES:1. Shake the bottle before consume.REFERENCES:1. X-Temp Oral Suspension System. Master Formulation Sheets 2013.13
5. AMLODIPINE SUSPENSION 1MG/MLGeneric NameIndicationDosage ensionSuspension1mg/mL30 daysRefrigerateINGREDIENTSAmlodipineDistilled waterVehicleSTRENGTHQUANTITY10mg6 tablets-3-4mLqs60mLVEHICLE OF CHOICE: X-Temp Oral Suspension SystemPROCEDURE:1. Crush tablets in a mortar to fine powder.2. Add 3-4mL of distilled water to disintegrate the tablets.3. Levigate the powder with small amount of vehicle until smooth paste is formed.4. Add more vehicle to the paste until liquid is formed and transfer the liquid into acontainer.5. Use additional vehicle to rinse the remaining drug from the mortar and pour intothe container.6. Make up to final volume with vehicle.7. Shake well and label.NOTES:REFERENCES:1. X-Temp Oral Suspension System. Master Formulation Sheets 2013.2. Pharmacy Compounding Manual 2008, Calgary Health Region Pharmacy.14
6. ATENOLOL SUSPENSION 2MG/MLGeneric NameIndicationDosage FormStrengthStabilityStorageINGREDIENTS: Atenolol: Hypertension, angina pectoris, myocardial infarction andarrhythmias: Suspension: 2mg/mL: 14 days or 90 days: RefrigerateSTRENGTHQUANTITYAtenolol100mg1 tabletGlycerin-2mLVehicleqs50mLVEHICLE OF CHOICE: Simple Syrup (stability 14 days) or Ora-Sweet (stability 14 days) or Ora-Sweet SF (stability 90 days)PROCEDURE:1. Crush tablets in a mortar to fine powder.2. Levigate the powder with glycerin until smooth paste is formed.3. Add vehicle to the paste until liquid is formed and transfer the liquid into acontainer.4. Use additional vehicle to rinse the remaining drug from the mortar and pour intothe container.5. Make up to final volume with vehicle.6. Shake well and label.NOTES:1. Ora-Sweet SF should not be used in neonates 28 days corrected age.REFERENCES:1. Patel D, Doshi DH, Desia A. Short term stability of Atenolol in oral liquid formulations.International Journal of Pharmaceutical Compounding 1997; 437-439.2. Pharmacy Compounding Manual 2008, Calgary Health Region Pharmacy.15
7. BACLOFEN SUSPENSION 5MG/MLGeneric NameIndicationDosage ty of the skeletal muscleSuspension5mg/mL35 daysRefrigerate and protect from lightINGREDIENTSSTRENGTHQUANTITYBaclofen10mg30 tabletsGlycerine-3mLqs60mLSimple SyrupPROCEDURE:1. Grind tablets in a mortar to fine powder.2. Add glycerin to make fine paste.3. Add about 15ml of simple syrup to the paste, triturate well and transfer thecontents into a graduated cylinder.4. Rinse the mortar with about 15ml of simple syrup and transfer the contents intothe graduated cylinder.5. Repeat the last step as necessary to bring the final volume to 60ml.NOTES:1. Keep in an amber glass bottle.REFERENCES:1. Johnson CE and Hart SM. Stability of an Extemporaneously Compounded Baclofen OralLiquid. Am J Hosp Pharm 1993;50(11):2353-5.2. Pharmacy Compounding Manual 2008, Calgary Health Region Pharmacy.16
8. BACLOFEN SUSPENSION 10MG/MLGeneric NameIndicationDosage icle::::::BaclofenSpasticity of the skeletal muscleSuspension10mg/mL60 daysRefrigerate (preferable) or at room temperature and protectfrom lightSTRENGTHQUANTITY10mg120 tabletsqs120mLVEHICLE OF CHOICE: Ora-Sweet : Ora-Plus (1:1) or Equivalent vehicle to Ora-Sweet : Ora-Plus (1:1) X-Temp Oral Suspension SystemPROCEDURE:1. Crush tablets in a mortar to fine powder.2. Levigate the powder with vehicle until smooth paste is formed.3. Add more vehicle to the paste until liquid is formed and transfer the liquid into acontainer.4. Use additional vehicle to rinse the remaining drug from the mortar and pour intothe container.5. Make up to final volume with vehicle.6. Shake well and label.NOTES:REFERENCES:1. Allen LV and Erickson MA. Stability of Acetazolamide, Allopurinol, Azathioprine,Clonazepam, and Flucytosine in Extemporaneously Compounded Oral Liquids. Am JHealth Sys Pharm 1996;53:1944-9.2. X-Temp Oral Suspension System. Master Formulation Sheets 2013.17
9. CAFFEINE CITRATE SOLUTION 10MG/MLGeneric NameIndicationDosage FormStrengthStabilityStorage::::::Caffeine CitrateApnoea of prematuritySolution10mg/mL30 daysRefrigerate and protect from lightINGREDIENTSSTRENGTHQUANTITYCaffeine Citrate Anhydrous BP-1gCitric acid anhydrous BP-1gqs100mLVehicleVEHICLE OF CHOICE: Distilled water or water for injectionPROCEDURE:1. Weigh the powders and mix with a small amount of vehicle in a measuringcylinder.2. Add more vehicle to the mixture and make up to final volume with the vehicle.3. Make up to final volume with vehicle and transfer into a suitable container.4. Shake well and label.NOTES:1. Chemically stable for at least 90 days but the potential for microbial growth wasnot assessed.2. Refrigeration recommended to reduce potential for micobial growth. Observefor precipitation.3. Equivalent to 5mg per mL anhydrous caffeine base.4. Shake well before consume.REFERENCES:1. Hopkin C, Taylor A, Hanson S.(1990) Stability study of caffeine citrate.Br J PharmPract.4: 133.2. PharmInfoTech: Database of Oral Liquid Formulations-eMixt. [Online] Available tion/mixtures/caffeine citrate.html[Accessed:15th Oct 2015].3. Nahata MC, Pai VB, Hipple TF. (2011) Pediatric Drug Formulation.6th Edition. HarveyWhitney Books.18
10. CAPTOPRIL SYRUP 1MG/MLGeneric NameIndicationDosage FormStrengthStabilityStorage: Captopril: i) Hypertensionii) Congestive heart failureiii) Post-myocardial infarctioniv) Diabetic nephropathy: Syrup: 1mg/mL: 30 days: Refrigerate and protect from lightINGREDIENTSCaptoprilSimple SyrupSTRENGTHQUANTITY25mg4 tabletsqs100mLPROCEDURE:1. Crush tablets in a mortar to fine powder.2. Levigate the powder with simple syrup until smooth paste is formed.3. Add more simple syrup to the paste until liquid is formed and transfer the liquidinto a container.4. Use additional vehicle to rinse the remaining drug from the mortar and pour intothe container.5. Make up to final volume with vehicle.6. Shake well and label.NOTES:1. Keep in an amber glass bottle.REFERENCES:1. Lye MY, Yow KL, Lim LY, et al.(1997) Effects of Ingredients on Stability of Captopril inExtemporaneously Prepared Oral Liquids. Am J Health Syst Pharm .54(21):2483-7.2. Pharmacy Compounding Manual 2008, Calgary Health Region Pharmacy.19
11. CAPTOPRIL SOLUTION 1MG/MLGeneric NameIndicationDosage FormStrengthStabilityStorageINGREDIENTS: Captopril: i) Hypertensioniii) Post-myocardial infarction: Solution: 1mg/mL: 56 days: Refrigerateii) Congestive heart failureiv) Diabetic nephropathySTRENGTHQUANTITYCaptopril25mg4 tabletsAscorbic Acid500mg1 tabletDistilled Waterqs100mLPROCEDURE:1. Allow the captopril tablets to dissolve in 50mL of distilled water in a graduatedcylinder.2. Add 500mg of ascorbic acid tablet to the mixture and make to final volume withdistilled water.3. Shake well and label.NOTES:1. A sulfur like odour is not indicative of captopril degradation.REFERENCES:1. Nahata MC, Morosco RS, and Hipple TF. (1994) Stability of Captopril
Extemporaneous Formulation, MOH 2015 Pharmaceutical Services Division, Ministry of Health Malaysia Lot 36, Jalan Universiti, 46350 Petaling Jaya, Selangor.
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