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Dosage form

From Wikipedia, the free encyclopedia
Any specific format for medications, specific to a dose and route
Tablets in ablister pack

Dosage forms (also calledunit doses) arepharmaceutical drug products presented in a specific form for use. They contain a mixture ofactive ingredients and inactive components (excipients), configured in a particular way (such as acapsule shell) and apportioned into a specificdose. For example, two products may both beamoxicillin, but one may come in 500 mg capsules, while another may be in 250 mg chewable tablets.

The termunit dose can also refer to non-reusable packaging, particularly when each drug product is individually packaged.[1] However, the FDA differentiates this by referring to it asunit-dose "packaging" or "dispensing".[2] Depending on the context,multi(ple) unit dose may refer to multiple distinct drug productspackaged together or asingle product containing multiple drugs and/or doses.

Formulations

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The termdosage form may also sometimes refer only to thepharmaceutical formulation of a drug product's constituent substances, without considering its final configuration as a consumable product (e.g., capsule, patch, etc.). Due to the somewhat ambiguous nature and overlap of these terms within the pharmaceutical industry, caution is advisable when discussing them with others who may interpret the terminology differently.

Types

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Dosage forms vary depending on the method/route of administration, which can include many types of liquid, solid, and semisolid forms. Common dosage forms includetablets, capsules,drinks,solutions,[3]suspensions,[4] andsyrups, among others.

Acombination drug (or fixed-dose combination; FDC) is a product that contains more than oneactive ingredient (e.g., one tablet, one capsule, or one syrup with multiple drugs).

Innaturopathy, dosages can take the form ofdecoctions andherbal teas, in addition to the more conventional methods mentioned above.

Route of administration

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Theroute of administration (ROA) fordrug delivery depends on the dosage form of thesubstance. Different dosage forms may be available for a particular drug, especially if certain conditions restrict the ROA. For example, if a patient is unconscious or experiencing persistentnausea andvomiting, oral administration may not be feasible, necessitating the use of alternative routes, such asinhalational,buccal,sublingual,nasal,suppository, orparenteral.

A specific dosage form may also be required due to issues such aschemical stability orpharmacokinetic properties. For instance,insulin cannot be given orally because it is extensivelymetabolized in thegastrointestinal tract (GIT) before it reaches thebloodstream, preventing it from reaching therapeutic target destinations. Similarly, the oral and intravenous doses of a drug likeparacetamol differ for the same reason.[5]

Oral

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Single unitpackets with full identification (text and bar codes)

Ophthalmic

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Vials of eye drops for single use

Inhalation

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Unintended ingredients

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Talc is anexcipient often used in pharmaceutical tablets that may end up being crushed to a powder against medical advice or for recreational use. Also,illicit drugs that occur as white powder in their pure form are oftencut with cheaptalc. Natural talc is cheap but containsasbestos while asbestos-free talc is more expensive. Inhaled talc that has asbestos is generally accepted as being able to cause lung cancer if it is inhaled. The evidence about asbestos-free talc is less clear, according to theAmerican Cancer Society.[6]

Injection

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Anampoule containing atropine injection 1mL/0.5mg

Parenteral

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These are usually solutions and suspensions.

Unintended ingredients

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Safe

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Eye drops (normal saline in disposable packages) are distributed to syringe users byneedle exchange programs.[citation needed]

Unsafe

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The injection of talc from crushed pills has been associated withpulmonary talcosis in intravenous drug users.[7]

Topical

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Unintended use

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  • It is not safe to calculate divided doses by cutting and weighing medical skin patches, because there's no guarantee that the substance is evenly distributed on the patch surface.[8] For example,fentanyl transdermal patches are designed to slowly release the substance over 3 days. It is well known that cut fentanyl transdermal consumed orally have cause overdoses and deaths.
  • Singleblotting papers for illicit drugs injected from solvents in syringes may also cause uneven distribution across the surface.

Other

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See also

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References

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  1. ^"unit dose".thefreedictionary.com.
  2. ^Affairs, Office of Regulatory."Compliance Policy Guides - CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms".www.fda.gov. Archived fromthe original on July 10, 2009.
  3. ^Brunaugh, Ashlee D.; Moraga-Espinoza, Daniel; Bahamondez-Canas, Tania; Smyth, Hugh D. C.; Williams, Robert O. (2024)."Solution-Based Dosage Forms and Sterile Products".Essential Pharmaceutics. Vol. 12. Cham: Springer International Publishing. pp. 91–107.doi:10.1007/978-3-031-52520-9_6.ISBN 978-3-031-52519-3. Retrieved2025-06-20.
  4. ^Kulshreshtha, Alok K.; Singh, Onkar N.; Wall, G. Michael, eds. (2010).Pharmaceutical Suspensions: From Formulation Development to Manufacturing. New York, NY: Springer New York.doi:10.1007/978-1-4419-1087-5.ISBN 978-1-4419-1086-8. Retrieved2025-06-20.
  5. ^"Doctors 'missed' fatal overdoses".BBC News. 4 February 2011.
  6. ^"Talcum Powder and Cancer".www.cancer.org.
  7. ^Davis, LL. (Dec 1983)."Pulmonary "mainline" granulomatosis: talcosis secondary to intravenous heroin abuse with characteristic x-ray findings of asbestosis".J Natl Med Assoc.75 (12):1225–8.PMC 2561715.PMID 6655726.
  8. ^Cohen, Michael R. (1 March 2013)."The danger with cutting medication patches: Institute for Safe Medication Practices".Pharmacy Today.19 (3): 88.doi:10.1016/S1042-0991(15)31507-3.ISSN 1042-0991. Retrieved17 May 2022.

External links

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Oral
Digestive tract (enteral)
Solids

Liquids
Oral mucosa (buccal,sublabial,sublingual,supralingual)
Solids
Liquids
Respiratory tract (inhalation)
Solids


Liquids
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Ophthalmic,
otic,nasal
Urogenital
Rectal (enteral)
Dermal (topical)
Parenterals,injections,
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(into tissue/blood)
Skin (transdermal)
Organs
Central nervous system
Circulatory,
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General
topics
Product
packages
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Materials
and
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Processes
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Environment,
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