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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5577_Библиотеки_им_академика_М_И_Перельмана.pdf
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
are the most popular pharmaceutical dosage form manufactured
and prescribed because they are portable, convenient and easy
to use.
About two-thirds of all prescriptions are dispensed as solid dosage
forms, and half of these are tablets. They are usually taken orally,
but can be administered sublingually, buccally, rectally or intravaginally. Tablets are made into many shapes and colors to help distinguish dierent types and brands of medicines. They are often
stamped with symbols or logos, and a combination of letters and
numbers, which enable them and the batches to which they belong
to be identified. The sizes and diameters of tablets to be swallowed
can range from a few millimeters to about a centimeter. Historically, a pill was defined as a small, round and solid pharmaceutical
dosage form compounded by an apothecary or pharmacist in his
pharmacy or drug store. The pharmacist strived to make round pills
as a demonstration of his compounding skill, and as a yardstick of
product quality. Today, the term “pills” has been used colloquially
to include tablets, capsules, and caplets (i.e., tablets that are shaped
like capsules).
14.4.1.2. Oral Dosage Forms — Liquids
Examples of oral dosage forms which are liquids include solutions,
suspensions and emulsions containing one or more drug substances
in a suitable vehicle. The choice of vehicle or carrier takes into
consideration the nature of the drug substances and also the need
to enhance organoleptic characteristics such as taste, smell, color
and overall appearance. Liquid preparations for oral use are often
supplied as multidose preparations. Each dose from a multidose
container is usually administered by means of a spoon or a cup of
Pharmaceutical Dosage Forms
volume 5 millitres, or multiples thereof. Oral liquid preparations
are often the dosage form of choice for pediatric use, where they
may be administered by an oral syringe or a suitable dropper.
Oral liquid dosage form
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14.4.1.3. Topical Dosage Forms
Topical dosage forms include pharmaceutical products where
the drug substance is usually dispersed in a semi-solid base, e.g.,
creams, ointments, gels and pastes. Topical dosage forms are
applied to the skin or other body cavities and surfaces, such as the
eye, ear and nose, mainly for local action. Creams are a common
topical dosage form applied mostly to the skin, but may also be
formulated for application to the mucous membranes of the rectum or vagina, or the eye, ear and nose for local treatment of various conditions aecting these organs. Many creams have also been
developed and manufactured for use as cosmetic products in the
highly lucrative cosmetic, spa, massage and aesthetic industries.
Ointments are used topically on a variety of body surfaces, including the skin and mucous membranes of the eye, chest, vulva, anus,
and nose. Ointments are generally greasy and good for dry skin.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
An ointment may or may not be medicated. As a dosage form,
ointments may be disliked by patients and other users due to their
inherent greasiness.
Topical dosage forms
14.4.1.4. Parenteral Dosage Forms (Injections)
These are usually solutions or suspensions consisting of drugs in
water or other suitable solvents which are sterile (free from microorganisms), particle-free and non-pyrogenic (free from endotoxins).
They are injected into the body using syringe and needle or by way
of an infusion set. Parenteral dosage forms include injections which
are administered to the patient through the intravenous route,
i.e., the blood vein; the intramuscular route, i.e., via the muscles
of the upper arm, leg or buttock; the subcutaneous route, i.e., into
and under the skin; the intraperitoneal route, i.e., into the peritoneum; or even through the intrathecal route, i.e., via the spinal
cord. Intrathecal injections are particularly useful for drugs that are
intended to reach the cerebrospinal fluid for anesthesia or severe
pain management.
Pharmaceutical Dosage Forms
435
Parenteral dosage form (injection)
The intravenous route is the fastest way to deliver medications
and fluid replacement because they are introduced directly into
the blood circulation. This route may be used to correct electrolyte imbalances, deliver drug molecules and for blood transfusions.
The intramuscular route is a common parenteral mode of administration because muscles have relatively large and numerous blood
vessels, and therefore a relatively higher rate of absorption than subcutaneous or intradermal injections. Examples of medications that
can be administered intramuscularly include atropine, morphine,
metoclopramide, streptomycin, penicillin, diazepam, prednisone
and sex hormones like testosterone, estradiol and medroxyprogesterone acetate. Platelet-rich plasma and vaccines, including those
for immunization against COVID-19, tuberculosis, rabies, hepatitis
and influenza infections are often administered as intramuscular
injections.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
A vial of COVID-19 vaccine for intramuscular injection
14.4.1.5. Inhaled Dosage Forms
Inhaled dosage forms are preferred when the drug is required to
be delivered in gaseous form or as an aerosol mist, or as ultrafine
solid particles into the lungs. This allows medicines to be delivered
to and absorbed into the lungs, enabling a more targeted medical
treatment of this specific region of the body, thus reducing the side
eects of oral medications. This dosage form is mainly for direct
treatment and management of respiratory diseases and other lung
conditions, especially asthma and chronic obstructive pulmonary
disease. Examples of inhaled dosage forms include powder aerosol
inhalers, nebulizers and pressurized metered-dose aerosols containing salbutamol, salmeterol, albuterol and other broncho-dilators, as
well as steroids such as beclomethasone, fluticasone and budesonide.
Each inhaled dosage form has its advantages and disadvantages;
they are selected based on assessment of specific patient needs, age,
ability to activate inhalers with coordinated breathing, and lung
functions. Proper education on inhaler use is of critical importance
Pharmaceutical Dosage Forms
especially for very young and elderly patients, to ensure that the
inhaled medicines exert their intended eects in the lungs.
Inhaled dosage form
437
14.4.1.6. Ophthalmic Dosage Forms
Ophthalmic dosage forms are usually sterile solutions, ointments
or suspensions, essentially free from particles that may irritate the
eyes. They are meant to be gently placed in the pocket between the
Ophthalmic dosage form (eye drops)
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
lower eyelid and the eyeball or applied to the lower eyelid. Eye drops
are the most common ophthalmic dosage forms.
Many eye drops are used to treat eye infection and inflammation,
and disorders such as glaucoma. Depending on the eye condition
being treated, eye drops may contain antibiotics such as chloramphenicol, neomycin and polymyxin, steroids such as dexamethasone, cholinergic drugs such as pilocarpine, as well as beta-blockers
such as timolol. Eye drops containing mainly normal saline and no
other medications in them are used largely as lubricants and tearreplacement solutions. Prior to the advent of single-use eye drops
equipped with sterile plastic applicators, eye drops were administered using an eye dropper which is a glass pipette with a rubber
bulb. Although most vials of eye drops contain anti-microbial preservatives to inhibit in-use contamination, it is recommended to
dispose the contents in the bottle no later than four weeks after
opening. Eye drops that contain no anti-microbial preservatives are
usually packaged for single use only.
Single-use eye drops
Pharmaceutical Dosage Forms
14.4.1.7. Nasal Dosage Forms
Nasal dosage forms comprise essentially formulations that are
non-sterile and aqueous-based, which are instilled within the nasal
cavity from a dropper or sprayed into the nasal cavity from a plastic
squeeze bottle. They are predominantly employed for the treatment of
local disorders such as nose infections, common cold, congestion, and
allergic rhinitis. Examples are nose drops containing phenylephrine.
Some nasal preparations are administered to achieve a systemic eect
via absorption of the drug molecules through the nasal mucosa.
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Nasal dosage form
14.4.1.8. Otic Dosage Forms
Otic dosage forms comprise non-sterile solutions prepared by dissolving the drug in water, glycerin or other suitable solvents, for
instillation into the ear canal for local treatment of certain ear
disorders. Ear drops containing a combination of an antibiotic
(ciprofloxacin) and a steroid (dexamethasone) are used to treat ear
infections such as acute otitis media and acute otitis externa (also
known as swimmer’s ear). Acute otitis externa is an infection of the
outer ear canal caused by bacteria.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Otic dosage form
14.4.1.9. Rectal Dosage Forms
Rectal dosage forms include suppositories, solutions or emulsions
which are administered into the rectum for local more than for systemic eects. These dosage forms can also be used to deliver drugs
that are inactivated by gastrointestinal fluids when administered
orally or when the oral route of administration is not possible, medically or otherwise.
Rectal dosage form (suppository)
Pharmaceutical Dosage Forms
14.4.1.10. Vaginal Dosage Forms
Vaginal dosage forms are intended to be used within the vaginal
cavity for either contraception, labor induction, treatment of vaginal infections (caused by bacteria and fungi) and local menopausal
symptoms. Commonly used vaginal dosage forms include creams,
gels and pessaries, foams and tampons.
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Vaginal dosage form (pessary)
14.4.1.11. Transdermal Patch
A transdermal patch is a medicated adhesive patch that is placed on
the skin to deliver a specific dose of medication through the skin
and into the bloodstream. Often, it is used to promote healing to
an injured area of the body. An advantage of a transdermal drug
delivery route over other delivery routes such as oral, topical, intravenous and intramuscular is that the patch provides a controlled
release of the medication into the patient. This is achieved through
either a porous membrane covering a reservoir of medication or
through body heat melting thin layers of medication embedded
in the adhesive. The main disadvantage to transdermal delivery