EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS

Extemporaneous Dosage
Forms:
Oral Liquids
Tammy Nguyen B. Pharm, MPS, Compounding Pharmacist, Medisca Australia

AFTER COMPLETING THIS ‘‘Oral liquids provide flexibility in dosing and are
ACTIVITY, PHARMACISTS beneficial when a patient requires dose titration,1
SHOULD BE ABLE TO:
1. List populations for which however, many pharmaceutical drug products are
the compounding of an oral not available as oral liquids2’’
liquid may be necessary Oral liquid preparations are a • patients with enteral feeding
2. Outline necessary versatile option for clinicians tubes
considerations that should looking for an alternative to the • patients with dysphagia or
be made by the pharmacist more common oral solid dosage aspiration
to ensure product stability form. Compounding pharmacists • veterinary patients
3. Describe methods used in may be required to prepare oral
the compounding of liquid liquids if an oral solid dosage form Oral liquids are separated into
preparations is unsuitable for a specific patient two main categories; solutions
or if the dosage required by the and suspensions3. Solutions are
patient cannot be practically one of the oldest pharmaceutical
The 2016 Standards addressed administered. This article dosage forms3. Solutions refer to
by this activity include: 1.3, 1.5, discusses the various types of oral liquids where all solid ingredients,
3.1, 3.2, 3.4, 3.6 liquids and specific suitability and including the active are fully
stability considerations related solubilised in a solvent(s)4. The
to them, including microbial and solvent may be aqueous or
First published in the Australian chemical. The compounding organic or a combination of both.
Journal of Pharmacy online pharmacist may have additional Examples of oral solutions include
version. 1st May 2019. considerations when dispensing syrups, elixirs, linctuses and
Reproduced and distributed oral liquids such as techniques aromatic waters.
by the Medisca Group of used for extemporaneous
companies with the permission preparations or when preparing Oral suspensions have insoluble
of the publisher. medications for animals. components that are suspended
in a dispersion medium with
Liquid preparations are an ideal suspending agents5. Suspending
choice for a wide range of clinical agents are used to aid in the
settings, including, but not limited dispersion of powders evenly
to: throughout the preparation
• infants and children to prevent the flocculation of
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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS

Table 1: Types of Solution3

Type of Solution Definition
Syrup Aqueous preparation containing a high proportion
of sucrose or another sweetener
Elixir A hydroalcoholic liquid containing syrup
Linctus A viscous liquid containing sucrose with a small
intended volume of administration
Aromatic Waters Saturated solutions of volatile liquids

particles in the preparations5,6. worldwide expectation that the for paediatric populations has led
Flocculated particles clump elderly will make up a greater to off-label or unlicensed use of
together and if the particles are proportion of the population4, adult medications. This practice
large enough, gravitational forces thereby potentially increasing the itself poses a risk to paediatric
pull the particles down resulting prevalence of dysphagia. patients as they are a distinct and
in sedimentation4. Alternatively, heterogeneous population which
if the particles clumped together Available Dosage Forms exhibit different pharmacokinetic
are relatively small, they can float The WHO List of Essential and pharmacodynamics when
to the top of the suspension and Medicines for Children9 and compared to adults13. All of these
result in creaming4. Suspensions, WHO List of Essential Medicines factors combined, indicate a
if poorly prepared can result for Adults10 lists 76 and 84 continuous need for liquid oral
in the inaccurate dosing to the medications, respectively, preparations in the health care
patient. available in an oral liquid or setting into the future.
powder for oral liquid out of
Dysphagia possible 433-listed medications. TGA-registered (when treating
Solid oral dosage forms are Tablet formulations tend to humans) and APVMA-registered
frequently unsuitable for children be more cost-effective for products (when treating
under the age of six7. Additionally, pharmaceutical companies animals) are the first choice of
between 25-45% of children in to develop11, and have the pharmacotherapy for clinicians,
general, suffer from dysphagia added benefits of being more as they have undergone
(difficulty swallowing)8. Dysphagia economical to transport and extensive scrutiny for safety,
is a condition also seen in elderly store compared to their liquid stability and efficacy prior to
populations due to the incidence counterparts11. being becoming available on
of age-related changes in salivary the Australian market. Part of
gland function8. The prevalence Pharmaceutical companies the documentation submitted
of dysphagia also increases may be challenged with greater to regulatory authorities are the
in patients with cognitive regulatory requirements when results of pharmacopeia tests,
dysfunction or neurodegenerative conducting studies for children, some of which will be discussed.
diseases, and in patients who resulting in the higher outlay Although extemporaneous
have had a stroke8. in investment for a smaller preparations are not required to
Global trends indicate a return given the smaller market undergo such tests, pharmacists
continuous increase in life potential11. The lack of availability can utilise pharmacopeia tests
expectancy, and thus there is a of manufactured formulations in order to manage the risks to

Table 2 Advantages and Disadvantages of Solutions4

Advantages Disadvantages
Drug may be immediately absorbed Drug stability may be reduced, due to events such as
hydrolysis
Homogeneous, no need to shake the Unpalatable tastes are difficult to mask
container
Some drugs are poorly soluble

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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS

Table 3 Advantages and Disadvantages of Suspensions4

Advantages Disadvantages
Drug may be more palatable when insoluble Container requires shaking prior to administration
Drug may be more stable when insoluble Reduced dose accuracy compared to solutions
Enable bulk administration of insoluble powders Risk of flocculation resulting in creaming or caking
patients using extemporaneous formulation, it is important that Safety Data Sheets (SDS) provided
preparations. pharmacists identify whether by chemical suppliers, detail the
the formulation is intended hazard status of the chemical15,
Modification of Manufactured to be immediate release or and can be useful when
Products in the Compounding modified release13. Crushing determining if a product is safe to
of Extemporaneous the commercial solid dosage crush and compound into a liquid
Preparations form products in a mortar and preparation.
Pharmacists and clinicians are pestle will alter the intended
faced with two options when it pharmacokinetics of the drug14. Suitability and Stability
comes to compounding a liquid The compounding pharmacist Pharmacists must perform a
preparation: may also have to overcome the risk assessment before the
1. To crush a commercially barrier of enteric or film coats in compounding of any preparation.
available product and order to pulverise the product This risk assessment should
incorporate it into a liquid adequately. The Do Not Rush encompass both the risk to the
preparation (and consider to Crush Handbook published compounding personnel and to
whether or not this is an by the Society of Hospital the patient15. The PPS provides
appropriate option) or Pharmacists of Australia, is the the patient-centred care model in
2. To use the raw Active primary resource for pharmacists Standard 5 and a risk assessment
Pharmaceutical Ingredients in Australia in determining tool in Appendix 7 to assist
(APIs) to prepare whether a commercial product pharmacists with this process15.
compounded preparations13. can be modified for direct Formulation considerations
oral administration or for the include but are not limited to
The Australian Pharmaceutical administration of medication solubility, stability, palatability
Formulary 24 (APF 24) and into enteral feeding tubes16. The and suitability. The United States
Professional Practice Standards resource also provides some Pharmacopeia (USP)/National
(PPS) recommend pharmacists guidance on the occupational Formulary (NF) defines stability
exercise caution when modifying risk to administrators posed due as the extent to which products
commercially available products to cytotoxicity, teratogenicity retain the same properties
to use in extemporaneous or hazardousness16. The drug and characters possessed at
preparations14,15. Modification hazard classification is used the time of its preparation17
of the commercial product can to make recommendations on and categorises stability into
pose a risk to the patient, as when products should not be five types: chemical, physical,
the excipients included in the crushed16. Chemicals that fall microbiological, therapeutic
commercial product may be within this category require Work and toxicological17. Suitability of
incompatible with the liquid Health Safety considerations for the formulation is particularly
formulation14,15 and are often of compounding15. The facility needs important for paediatric patients,
undisclosed concentrations. If to be appropriately equiped as excipients widely used for
the compounding pharmacist with powder containment hoods adults, may not be suitable for
is required to use several units and Heating Ventilation Air infants or children18.
of the commercial product, the Conditioning (HVAC) systems,
increased amount of excipient in order to protect both the Additional formulation
may cause instability and operator and the external considerations will include
sedimentation. environment. The compounding whether the pharmacist
personnel are also required chooses to compound the
Prior to using a commercial to have appropriate Personal extemporaneous liquid using
product in an extemporaneous Protective Equipment (PPE)15. a proprietary oral liquid base
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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS
or prepare a base from raw Syrspend®. These proprietary that over time the microbial
ingredients. Formulations vehicles eliminate the need load of the preparation has not
based on published literature for compounding personnel to increased significantly beyond
may include both types of prepare an oral vehicle on each stated allowable limits. An AET
preparations. Manufactured occasion. As these bases are or PET can only be performed if a
proprietary bases will often take manufactured under Code of preservative has been included in
into consideration unsuitable Good Manufacturing Practice the formulation. Products labelled
excipients for paediatric patients, conditions, they have a longer as “preservative free” may
as they have been designed for shelf life than vehicles prepared undergo other microbial studies
use in both adults and children. in the compounding pharmacy. such as USP <61> and USP <62>24,
25
It is important for pharmacists . These tests are used to identify
The USP/NF lists standard to ensure the vehicle chosen and quantify microbes found
formulas for vehicles for oral is suitable for the API being in the product.24, 25 A successful
solutions and vehicles for prepared. The specification for pass means that product still falls
suspensions under the following USP/NF oral vehicles requires within an accepltable microbial
listing Vehicle for Oral Solution these vehicles to be slightly load limit despite not containing
NF, Vehicle for Oral Solution acidic (pH 4.0-5.0) in nature19-21. a preservative24,25 and is a method
Sugar-Free and NF Vehicle for Oral Compounding pharmacists need of assuring microbial stability.
Suspension NF19-21. These vehicles to assess using literature, the
are prepared before the addition optimal pH for the stability of the Proprietary oral vehicles may
of the appropriate APIs, required API. undergo stability-indicating
for the formulation. As per the studies for specific concentrations
USP guidelines for beyond use Acid-labile APIs require additional or bracketed concentrations
dates, in the absence of further ingredients to adjust or buffer of particular APIs in identified
stability data, these vehicles the pH of the formulation. compounded formulations.
can be kept for six months after Proton pump inhibitors such Stability-indicating studies is a
the date of preparation 19-21. In as omeprazole, esomeprazole, method of assurance of chemical
Australia, the APF 24 makes no lansoprazole, pantoprazole and stability. Depending on the
such recommendations for the rabeprazole are acid-labile. study results, these formulations
preparations of oral vehicles. In Bulk-manufactured proprietary may permit pharmacists to
the absence of stability studies, alkaline oral vehicles are designed assign a longer expiry date
the APF 24 allows a maximum to facilitate the preparation of to the oral liquid, beyond the
expiry date of 28 days for all acid-labile APIs. 28 days stipulated by the APF
compound liquid preparations14. 2414. Stability indicating studies
This can pose a practical challenge Some proprietary vehicles have should include information on
to pharmacists in Australia, as additional pharmacopeia testing the specific closure container
compounded oral vehicles must such as the antimicrobial efficacy system as well as the storage
be prepared immediately prior to test (AET) or preservative efficacy conditions for the shelf life of
the addition of active ingredients test (PET), to provide pharmacists the compound26. To assign
for an expiry date of 28 days to be an additional level of quality the extended expiry date,
assigned. Consequently, both the assurance. Microbial load in oral compounding pharmacists must
time required to compound and liquid preparations, is a relevent not deviate from the formulation
the cost of the preparation, are consideration when dispensing that was studied.
increased. medications to children, the
elderly and immunocompromised Stability-indicating studies
Alternatively, there are several patients. Microbial studies can be must use a validated method.
proprietary oral suspending performed on both the starting Validation is achieved by force
vehicles available on the oral vehicle or the finished degrading the active ingredient by
Australian market. Examples preparation. Both the USP and exposing it to known degraders,
include Medisca’s Oral MixTM, the British Pharmacopeia (BP) such as high heat, high humidity,
Professional Compounding outline validated methods for UV radiation, acid, base and
Chemists of Australia’s (PCCA) testing antimicrobial efficacy23,24. peroxide27. Stability-indicating
Suspendit® and Fagron’s Successful passing, confirms studies cost significant more
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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS

Figure 1: Decision tree for compounding liquids for children and adults

Table 4 Excipients, which pose toxicity and safety, risk to newborns

and infants < 6 months18
Excipient Common Functions
Benzyl alcohol Solvent, preservative
Ethanol Solvent, preservative
Propylene glycol Levigating agent, solvent, preservative
Polysorbate 20 Surfactant, emulsifier
Polysorbate 80 Surfactant, emulsifier

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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS
than potency assays, are often completely inert, toxic or harmful begins to rapidly decompose at
published in journals or white to the patient, or exhibit an pH 7.830. Omeprazole is known
papers. Pharmacists should be increased therapeutic activity to to be sensitive to heat, humidity,
aware that the pharmacopeia the original chemical. light and organic solvents.32 The
requirements for stability- degradation of omeprazole can
indicating studies have changed Databases, which list the be significantly slowed when the
over time. The method used compatibilities of specific active is protected from light32.
should be thoroughly scrutinised, bases, are not the same as
as current requirements are stability-indicating study results. Dosage for omeprazole in children
more stringent. The updated Compatibility results only is dependent on weight, which
version of USP<795>, due to be consider whether the APIs and makes an oral liquid an ideal
implemented in the USA from the base are physically stable rather choice of dosage form given
1st of December 2019, requires than examining chemical stability. the ease of dose adjustment.14
stability indicating studies to Commercially-available capsule
perform and pass additionally: We will now look at a common products and delayed release
1. an antimicrobial efficacy condition, which may present in or enteric coated tablets are
test on certain aqueous the pharmacy and compare two all designed to offer protection
preparations methods of preparing an oral of the API from stomach acid.
2. the container-closure needs liquid to facilitate appropriate However these dosage forms
to be studied28. treatment for a child. are usually unsuitable when
dispensing for children.
A stability-indicating study is Case Study – Omeprazole
not necessarily the same as Suspension The APF 24 provides a
a strength or potency assay. Omeprazole is a proton pump formulation where the
Stability-indicating studies inhibitor indicated for children omeprazole is suspended
may indicate potency, but for the treatment of gastro- in a buffered 8.4% sodium
not necessarily vice versa27. A oesophageal reflux disease bicarbonate solution14. The
potency assay performed at (GORD).14 Omeprazole suppresses APF24 formulation allows the
different times, only determines the secretion of gastric acid by pharmacist to prepare the liquid
the amount of the drug present inhibiting the (H+/K+ ATPase) with either the raw API or the
over time27. Some potency tests enzyme system, also referred commercially available capsules.
do not distinguish how much to as the ‘proton pump’ of the Compounding suppliers have also
of the drug is a degraded over gastric parietal cell29. Other formulated bases buffered in an
time, as degradants may still indications for omeprazole alkaline environment to reduce
appear on the potency assay include management of the degradation of omeprazole31.
due to a similarity in chemical peptic ulcer disease, H. Pylori The formulation prepared with a
structure27; whereas a stability- eradication and Zollinger-Ellison proprietary base has a supporting
indicating assay always identifies syndrome. stability indicating study to
the API concentration from justify an extended expiry date.
its degradants. Degradants of Omeprazole is white to off- However, the formulation must
analytes do not necessarily have white powder slightly soluble be prepared with the raw API to
the same therapeutic action as in water and sparingly soluble assign this longer expiry date. Due
the original active ingredient. in alcohol29. Omeprazole is to the degradation of omeprazole
A degradant may be either optimally stable at pH 11 and by light, an amber closure system
is the final dispensing container of
choice in both formulations14,31.

Formula: Omeprazole 2mg/mL

(100 mL)14 - See table 5
Method of Preparation
1. Weigh out omeprazole and
sodium bicarbonate
Figure 2 Structure of Omeprazole33 2. Dissolve sodium bicarbonate
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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS

in purified water. and add additional purified and there is sufficient evidence
3. Add compound water to the required batch of stability for the specific
hydroxybenzoate solution size and shake vigorously. formulation.
4. Add omeprazole to form Expiry Date: 70 days after
white dispersion preparation. Refrigerate at 2-8oC, Pharmacists may prepare an oral
5. pH should be adjusted to USP <61> and USP <62> pass after vehicle in their laboratory or use a
be above 8 using sodium 70 days31. proprietary base. Manufacturers
hydroxide solution 10% Storage: Amber, UV resistant of proprietary bases may have
Expiry Date: 28 days after polypropylene bottle studies or data to support
preparation. Refrigerate at the evidence of chemical and
2-8oC14 Conclusion microbial stability with specific
Storage: Glass Amber Bottle Oral liquids are an important APIs. These considerations
dosage form option when treating may mitigate the risk to the
Formula: Omeprazole 10mg/mL paediatric and geriatric patients. patients using medications
(100mL) Oral Liquid Suspension30 Although oral solid dosage forms extemporaneously prepared and/
-See table 6 are more prevalent, they are or “off label”.
Method of Preparation not appropriate for all patients,
1. Weigh out omeprazole and hence pharmacists may be
Oral Mix Dry Alka. required to prepare an oral liquid
2. Combine and triturate the extemporaneously if there is
powders to form a fine no suitable registered product.
homogeneous powder. Pharmacists must undertake risk
3. Incrementally add the assessments and use professional
purified water (60 mL) to the guidelines when formulating
powder blend and disperse medications into oral liquids,
the powders. to ensure the dosage form is
4. Transfer to dispensing bottle appropriate for the patient

Table 5: Formula: Omeprazole 2mg/mL (100 mL)14

Ingredient/Chemical Quantity Unit

Omeprazole* 0.200 g
Sodium bicarbonate 8.400 g
Compound hydroxybenzoate 1.0 mL
solution
Purified Water, USP q.s. to 100.0 mL
*omeprazole 20mg capsules may be used but may take longer
to form a dispersion due to the enteric coated pellets (up to 2
hours)

Table 6: Formula: Omeprazole 10mg/mL (100mL) Oral

Liquid Suspension30
Ingredient/Chemical Quantity Unit
Omeprazole USP 1.000 g
Oral Mix Dry Alka, SF (Cherry 6.750 g
Flavoured)
Purified Water, USP 60.0 mL

Purified Water, USP q.s. to 100.0 mL

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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS
28. Open Microphone Session on USP
References Formulary and Handbook. 24th ed.
General Chapter <795> Pharmaceutical
1. Dodou K, Nazar H. Oral formulations Canberra: The Pharmaceutical Society of
Australia; 2018. Compounding – Nonsterile Preparations.
adapted for the old and the young
15. Professional Practice Standards Version Presentation presented at; 2018; http://
and to prevent misuse [Internet].
5, June 2017. Pharmaceutical Society of www.usp.org/sites/default/files/usp/
Pharmaceutical Journal. 2012 [cited
Australia, 2017 document/our-work/compounding/795-
13 December 2018]. Available from:
16. Burridge N, Symons K. Australian open-microphone-presentation.pdf.
https://www.pharmaceutical-journal.
don’t rush to crush handbook. 3rd ed. 29. Sweetman SC, Blake PS. Martindale. The
com/news-and-analysis/news/
Collingwood, Vic.: Society of Hospital Complete Drug Reference, London. 2011
oral-formulations-adapted-for-the-
Pharmacists of Australia; 2017. Dec.
old-and-the-young-and-to-prevent-
17. United States Pharmacopeia 30. Trissel L. Trissel’s stability of
misuse/11102478.article?firstPass=false
Convention. “<1191> Stability compounded formulations. Washington,
2. Cram A, Breitkreutz J, Dessetbrethes
considerations for dispensing>” In DC: APhA; 2012
S, Nunn T, Tuleu V. Challenges of
United States Pharmacopeia 41 - 31. Bracketed Stability of Extemporaneously
developing palatable oral paediatric
National Formulary 36. Rockville, MD, Compounded Omeprazole 2, 5 and 10
formulations. International Journal of
2018 mg/mL in Oral Mix Dry Alka, SF (Cherry
Pharmaceutics. 2009;365(1-2):1-3.
18. Ivanovska V, Rademaker C, van Dijk Flavored) [Internet]. Medisca; 2018
3. Allen L. Art, Science, and Technology of
L, Mantel-Teeuwisse A. Pediatric [cited 28 November 2018]. Available
Pharmaceutical Compounding, (The) 5e.
Drug Formulations: A Review of from: https://www.medisca.com/
Washington, DC: American Pharmacists
Challenges and Progress. PEDIATRICS. Pages/Studies/pdf-files/white-papers/
Association; 2016.
2014;134(2):361-372. Bracketed%20Stability%20of%20
4. Marriott J, Wilson K, Langley C, Belcher
19. United States Pharmacopeia Extemporaneously%20Compounded%20
D. Pharmaceutical compounding and
Convention. “Vehicle for Oral Solution Omeprazole.pdf
dispensing. 2nd ed. Pharmaceutical
(Monograph)” In United States 32. Iuga C, Bojita M. Stability study of
Press; 2010.
Pharmacopeia 41 - National Formulary omeprazole. Farmacia. 2010 Mar
5. Remington: The Science and Practice
36. Rockville, MD, 2018 1;58(2):203-10.
of Pharmacy. London: Pharmaceutical
20. United States Pharmacopeia 33. United States Pharmacopeia
Press; 2012.
Convention. “Vehicle for Oral Solution Convention. “Omeprazole (Monograph)”
6. THE SCIENCE OF PHARMACEUTICAL
SF (Monograph)” In United States In United States Pharmacopeia 41 -
COMPOUNDING: NON-STERILE
Pharmacopeia 41 - National Formulary National Formulary 36. Rockville, MD,
TRAINING. Montreal: LP3 Network Inc.;
36. Rockville, MD, 2018 2018
2018
7. Batchelor H, Marriott J. Formulations 21. United States Pharmacopeia
for children: problems and solutions. Convention. “Vehicle for Oral
British Journal of Clinical Pharmacology. Suspension (Monograph)” In United
2015;79(3):405-418. States Pharmacopeia 41 - National
8. Dijkers E, Nanhekhan V, Thorissen A, Formulary 36. Rockville, MD, 2018
Polonni H. Suspensions as a Valuable 22. United States Pharmacopeia
Alternative to Extemporaneous Convention. “<51> Antimicrobial Efficacy
Compounded Capsules. International Testing” In United States Pharmacopeia
Journal of Pharmaceutical 41 - National Formulary 36. Rockville,
Compounding. 2017;21(2):1171-175. MD, 2018
9. WHO Model List of Essential 23. British Pharmacopoeia – Efficacy of
Medicines [Internet]. 20th ed. World antimicrobial preservation In 2014
Health Organisation; 2017 [cited 29 Appendix XVIC
November 2018]. Available from: 24. United States Pharmacopeia
https://apps.who.int/iris/bitstream/ Convention. “<61> Microbiological
handle/10665/273826/EML-20-eng. Examination of Nonsterile Products:
pdf?ua=1 Microbial Enumeration Tests“ In United
10. WHO Model List of Essential Medicines States Pharmacopeia 41 - National
for Children [Internet]. 20th ed. World Formulary 36. Rockville, MD, 2018
Health Organisation; 2017 [cited 29 25. United States Pharmacopeia
November 2018]. Available from: Convention. “<62> Microbiological
https://apps.who.int/iris/bitstream/ Examination of Nonsterile Products:
handle/10665/273826/EML-20-eng. Tests for Specified Microorganisms.”
pdf?ua=1 In United States Pharmacopeia 41 -
11. Lau E, Steadman K, Cichero J, Nissen L. National Formulary 36. Rockville, MD,
Dosage form modification and oral drug 2018
delivery in older people. Advanced Drug 26. United States Pharmacopeia
Delivery Reviews. 2018;135:75-84. Convention. “<795> Pharmaceutical
12. Ivanovska V, Rademaker C, van Dijk Compounding-Nonsterile Preparations”
L, Mantel-Teeuwisse A. Pediatric In United States Pharmacopeia 41 -
Drug Formulations: A Review of National Formulary 36. Rockville, MD,
Challenges and Progress. PEDIATRICS. 2018
2014;134(2):361-372 27. Allen L, Bassani, G, Elder E, Parr A.
13. Haywood A, Glass B. Liquid Dosage STRENGTH AND STABILITY TESTING
Forms Extemporaneously Prepared FOR COMPOUNDED PREPARATIONS
from Commercially Available Products – [Internet]. USP.org. 2014 [cited 28
Considering New Evidence on Stability. November 2018]. Available from:
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Sciences. 2013;16(3):441. usp/document/FAQs/strength-stability-
14. Sansom L. Ed. Australian Pharmaceutical testing-compounded-preparations.pdf
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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS

CPD MULTIPLE CHOICE QUESTIONS

1. What is the maximum expiry date applied to a compounded liquid in the absence of stability-indicating study as
per Australian Pharmaceutical Formulary 24 (AFP 24)?
A. 14 days
B. 6 months
C. 28 days
D. 90 days

2. A potency assay test over time is enough to indicate stability

A. True
B. False

3. Which of the following can be appropriately crushed for the preparation of oral liquids.
A. Slow release tablets
B. Cytotoxic tablets
C. Immediate-release tablets
D. Enteric coated capsules

4. Populations in which oral liquids may be utilised for increased compliance include
A. paediatrics
B. geriatrics
C. animals
D. all of the above

5. Forced degradation involves exposing the active ingredient to known degraders, such as high heat, high humidity,
UV radiation, acid, base and peroxide. This procedure is used in:
A. an antimicrobial efficacy test
B. a stability-indicating study
C. a preservative efficacy test
D. a microbial examination for non-sterile products

6. Consider the statements below regarding stability-indicating studies and choose the most correct answer:
I. Stability-indicating studies are carried out for at least 6 months, whilst potency studies are carried out for any
selected time period
II. Stability-indicating studies always assay the API under forced degradation, whilst potency studies do not
III. Stability-indicating studies include specific packaging and temperature conditions
IV. Stability-indicating studies always separate the API from it’s degradants, whereas potency studies do not

A. I. is correct
B. Only II and III are correct
C. II, III and IV are correct
D. All are correct

7. The Australian Pharmaceutical Formulary 24 (APF 24) and Professional Practice Standards (PPS) recommend
pharmacists:
A. modify commercially available products to use in extemporaneous preparations where possible.
B. exercise caution when modifying commercially available products to use in extemporaneous preparations
C. never use a commercially available product to compound into a liquid preperation
D. modify commercially available products to use in extemporaneous preparations where possible, ensuring
they disclose concentrations of all excipients.

QUESTIONS CONTINUED ON NEXT PAGE

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 EXTEMPORANEOUS DOSAGE FORMS: ORAL LIQUIDS

CPD MULTIPLE CHOICE QUESTIONS

8. Compounded omeprazole suspensions should be stored in a clear glass bottle.
A. True
B. False

9. Choose the INCORRECT option.

A. Proprietary oral suspending agents have a longer shelf life than vehicles prepared in the compounding phar-
macy
B. Compounding pharmacists do not need to consider the pH of the formulation they are compounding, as oral
proprietary suspending vehicles adjust the pH themselves
C. Some proprietary vehicles have additional pharmacopeia testing, which provides pharmacists with a higher
level of quality assurance
D. All of the above options are incorrect

10