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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Table 3: Proposed regulatory framework for hand sanitizers
Listing or
certification
Claims and
advertisements
Labelling
Sale and supply • Should not be sold in bulk packs
• Manufacturers must submit application, detailing test
methods and results, GMP compliance status, and intended
packaging and labels
• A listing or certification number is given after approval
by RAs
• Exemption or expedited review is allowed for those formulations and concentrations recommended by WHO, USP
and CDC. Only packaging, labels and advertising claims
need to be submitted
• Prohibit claims on therapeutic indications
• Prohibit claims that are false or misleading regarding the
formulation, eectiveness and safety of the product
• Advertisements do not require an advertiser’s license, however, should only be limited to their own company websites
so that consumers self-initiate the search themselves
• Main label must contain the active ingredient(s), concentration and units, expiry date
• Must include cautionary labels relating to flammability of
ABHS and methanol toxicity
• Can only claim eectiveness against test organisms that
have been studied
• Prohibit labelling claims of 99.9% kill
• Prohibit peel-back labels which are labels that have addi-
tional information below the exposed label
• Texts should not be too small, crowded and cluttered
• Should not be enclosed in bottles or containers resembling
food packages
placed in the market. Product licensing or registration is not always
feasible as it can severely increase regulatory costs. Therefore, the
proposed idea balances the current lack of regulatory oversight versus over-regulation and increasing compliance costs. Moreover, to
Hand Sanitizers
safeguard consumers, sale in bulk volumes/packs should be prohibited, hand sanitizers should not be enclosed in bottles resembling
food packaging and cautionary labels should be mandatory. Regulations should also include the need to perform the ecacy tests
(Section 4) and to seek approval by RAs to ensure eectiveness of
hand sanitizers. Additionally, it is important to prevent consumer
misinformation by restricting advertisements to company websites,
prohibiting unfounded claims and labelling of a blanket claim on
killing 99.9% of microorganisms.
The proposed framework may encounter diculty for international
harmonization. Similar to other health products, such as therapeutics, quasi-medicinal products and medical devices, dierences in
regulations exist across RAs. Furthermore, a tighter framework
adds regulatory burden and redirects resources away from more
important domains, such as other higher-risk medicinal products.
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Training pharmacists on hand sanitizer vigilance
Hand sanitizers may be sold in pharmacies or other retail outlets.
In comparison to supermarkets and other general retail outlets,
pharmacies are managed under the personal supervision of licensed
pharmacists. Hence, pharmacies have been perceived to be ethical
retail outlets which oer for sale and supply health products, including hand sanitizers, that are reliable. Pharmacies should restrict
themselves only to the sale of reliable and accurately labelled hand
sanitizers to safeguard consumer health. Pharmacists can be trained
to possess adequate knowledge on the regulations of antiseptics.
This could be performed through the provision of regulatory and
international guidelines. The knowledge could be used to identify
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
inappropriately sold hand sanitizers and pharmacists should be
given the autonomy to request for removal of the product from the
store. In fact, pharmacists should better educate and address consumers’ queries on hand sanitizer eectiveness.
Public Education
Apart from regulation, conscious eorts should be placed on educating the public. Consumers hold misconceptions about hand sanitizers and safety issues have occurred due to the lack of knowledge
in this field. Therefore, public education is necessary in collaboration with relevant stakeholders [99, 100]. Public education can focus
on general hand hygiene, including the myths and benefits of hand
sanitizers and the harms of using disinfectant-grade antimicrobial
agents interchangeably with antiseptic-grade skin formulations.
Additionally, collaborations with pharmacies can be explored. For
example, the placement of posters next to sales counters of hand
sanitizers can provide a second line of defense to combat consumers’ misinformation. Some content could include sharing on the
WHO 6 Steps of ‘How to hand- rub’ technique to promote eective
use and storage advice to reiterate safety precautions. Collaboration
with stakeholders facilitates the education of a wider target group
due to the extensivity of outreach. Collaborative education also
reduces the burden on regulators.
Conclusion
The multifaceted challenges of safety, eectiveness will grow
and hence, regulatory control will continue to evolve with the
Hand Sanitizers
progression of COVID-19 pandemic. This paper has shown that hand
sanitizers are assets to hand hygiene, especially during the COVID19 pandemic, provided they are used properly. Therefore, educating the public on hand sanitizers, including misleading claims and
proper use, is crucial. ABHS remain the mainstay as recommended
by WHO and other international organizations and should be more
tightly regulated due to safety concerns. Future developments can
consider the feasibility of international harmonization of regulations and explore other standards for testing ecacy that may be
more representative of all microorganisms. A tripartite relationship
among consumers, regulators and manufacturers should be established for the ultimate benefit of everyone.
Competing interests: None.
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Provenance and peer review: Not commissioned; externally peer
reviewed.
Authors
Adjunct Associate Professor Sia Chong Hock, BSc Pharm, MSc Tan
Ying Ting, BSc Pharm (Hons)
Associate Professor Chan Lai Wah, BSc Pharm (Hons), PhD
Department of Pharmacy
National University of Singapore
18 Science Drive 4
Singapore 117543
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
References
This article has 114 references which can be found at https://gabijournal.net/microbiological-scientific-and-regulatory-perspectivesof-hand-sanitizers.html.
Chapter 14
Pharmaceutical Dosage Forms
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14.1. Introduction
his chapter on pharmaceutical dosage forms is largely
derived from the lectures on Dosage Form Design
delivered by the co-author (Professor Chan Lai Wah) to
T
Professor Chan Lai Wah delivering a lecture and receiving Honor Roll (Award)
from NUS president
pharmacy undergraduates at the National University of
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Singapore (NUS). Over the years, Professor Chan has shared her
knowledge and experience with multiple cohorts of students and
won numerous awards for her excellence in teaching.
14.2. What Are Pharmaceutical Dosage Forms?
As a patient, consumer or lay person, you may have come across
the term “pharmaceutical dosage forms” in some technical magazines or newsletters which you have read. Or perhaps, you may
have seen these words appearing on the labels or package inserts of
the medicinal products which you have been prescribed, or bought
over-the-counter (OTC) from pharmacies and drug stores. What
do you understand by pharmaceutical dosage forms? Put simply,
pharmaceutical dosage forms refer to the dierent presentations
of medicinal products. These dierent presentations contain the
active pharmaceutical ingredients and excipients which are mixed
Dierent pharmaceutical dosage forms
Pharmaceutical Dosage Forms
together and formulated or “configured”, to facilitate easy administration and accurate delivery of the active pharmaceutical ingredient(s) to the target receptor sites in the human body.
14.3. Why Are Dierent Pharmaceutical Dosage
Forms Needed?
Within the hospital wards, accident and emergency departments,
operating theatres as well as medical clinics, pharmacies and drug
stores in the community, a whole range of medicinal products in
various pharmaceutical dosage forms are stocked for urgent or routine dispensing and supply. These dierent pharmaceutical dosage
forms, or simply dosage forms, are needed for a number of reasons
such as convenience in consumption by patients, dosing accuracy,
portability, as well as solubility and stability of the drug substances.
Depending on the age of patients and their ability to administer medicines by themselves, some dosage forms are preferred to
others. Moreover, dierent diseases and medical conditions may
warrant dierent routes of administration of the medicinal products to the patient. Dosage forms such as tablets, capsules and liquid
mixtures are usually taken orally. However, there may be certain
medical conditions that make oral consumption highly challenging. For example, persistent nausea, especially with vomiting, may
make it unsuitable to use an oral dosage form. In such a case, it
is necessary for a doctor or pharmacist to recommend a dosage
form which can be administered via an alternative route, such as a
suppository which is administered via the anal-rectal route, or an
injection which is administered via the parenteral route. Furtheremore, a specific pharmaceutical dosage form may be needed due to
other factors such as the chemical stability or pharmacokinetics of
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
the drug substance. A case in point is insulin which cannot be given
orally because this hormonal medicine for treating diabetes will be
extensively broken down in the gastrointestinal tract (GIT) before
reaching the blood stream of the patient, rendering it incapable of
reaching its target sites in sucient dose. Furthermore, some drugs
when given orally will undergo first-pass metabolism in the liver,
rendering them ineective.
In summary, pharmaceutical dosage forms are needed for various
purposes, such as, but not limited to, the following examples:
• to mask undesirable taste or oensive odor of a drug substance,
e.g., capsules, sugar-coated tablets and taste-masked suspensions.
• to protect the drug substance from the destructive influence of
gastric juice following oral administration of the dosage form,
e.g., enteric-coated tablets and film-coated tablets.
• to provide drug products that bypass the first-pass metabolism,
e.g., injections, topical creams and ointments.
• to achieve rapid onset of action following drug delivery, e.g.,
injections and inhalers.
• to provide a suitable dosage form for administering poorly
water-soluble or insoluble drugs in an appropriate vehicle, e.g.,
suspensions.
• to provide sterile, clear and particulate-free liquid dosage forms
of drug substances, e.g., injections and eye drops.
• to provide drug products with a predetermined release rate and
therapeutic eect over an extended period of time, e.g., modified-release tablets, capsules and suspensions.
• to prevent a drug from being extensively metabolized in the
GIT before reaching the blood stream, rendering it incapable of
reaching its target destination in sucient dose, e.g., injections.
Pharmaceutical Dosage Forms
• to achieve improved bioavailability and drug targeting e.g., solutions and nano-formulations.
14.4. How Are Pharmaceutical Dosage Forms
Classified?
Pharmaceutical dosage forms may be classified based on the routes
of administration or their physical forms.
14.4.1. Routes of Administration
14.4.1.1. Oral Dosage Forms — Solids
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Oral dosage forms comprise medicinal products taken via the
mouth, following which the drug molecules are absorbed through
the epithelia and mucosa of the GIT at varying rates. Oral dosage
forms may be in solid or liquid state. Examples of oral solid dosage
forms include tablets, capsules, pills, granules and powders. Tablets
Oral solid dosage form