Overview
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ABSTRACT
The suppository allows for the administration of active substances rectally in order to obtain a local or systemic effect. It consists of hydrophilic excipients, such as glycerol and polyethylene-glycols, which dissolve in water, or lipophilic excipients, such as mixtures of glycerides which melt at the rectal temperature. Although the acceptability of the suppository varies according to the sociocultural barriers of prescribers and patients, it is however extremely useful in pediatrics, geriatrics and in the case of certain digestive disorders. This article deals with the materials and methods used to formulate, produce and characterize suppositories, as well as with certain aspects of the rectal route of the biopharmaceutical area.
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Read the articleAUTHORS
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Vincent JANNIN: Pharmacy Project Manager - Gattefossé SAS
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Jean-David RODIER: Lipochemical research manager - Gattefossé SAS
INTRODUCTION
The modern pharmaceutical industry offers a wide range of routes of administration and pharmaceutical forms for delivering active ingredients to the site of action. Among these routes, the oral route is the most widely used, with tablets and capsules in particular. Alongside these are the topical, parenteral and rectal routes. The latter is one of the oldest routes of administration, with enemas and suppositories as the main pharmaceutical forms.
The European Pharmacopoeia (EP) defines a suppository as a solid unit preparation whose shape, volume and consistency are suitable for rectal administration.
Suppositories may contain one or more active substances dispersed or dissolved in the suppository mass. These masses are either hydrophilic, dissolving or dispersing on contact with the water in the rectal ampoule, or lipophilic, melting at rectal temperature. The suppository masses referenced in the EP are macrogols and gelatinous mixtures, for hydrophilic masses, and hemisynthetic glycerides and cocoa butter, for lipophilic masses. The US Pharmacopoeia (USP) and the Japanese Pharmacopoeia (JP) also define a suppository as a pharmaceutical form suitable for administration in the rectum or vaginal cavity. Suppository masses are identical to those described in the EP, with the addition of hydrogenated vegetable oils, fatty acid esters and polyethylene glycols (PEGs).
Suppositories are typically produced by molding, either in metal molds on a laboratory scale, or directly in plastic or aluminum blisters on an industrial scale. The EP also describes numerous pharmacotechnical tests to verify the quality and functionality of these formulations.
Although suppositories are not the preferred dosage form for patients, they are nonetheless essential when the patient is unable to swallow a tablet (infants, elderly people with swallowing problems, adults with vomiting problems, etc.). The pediatric and geriatric populations are particularly targeted by this dosage form.
The main active ingredients sold in suppository form for a local effect are glycerine or bisacodyl for constipation, or mesalazine for irritable bowel syndrome. For a systemic effect, the main ingredients are paracetamol, ibuprofen, diclofenac and oxycodone for pain and fever .
However, the suppository market remains a niche market with low growth rates. The annual growth rate for suppository bases is estimated at 2.7% worldwide and 3.2% in Europe (source:
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KEYWORDS
| rectal route | excipient | formulation | pharmaceutics
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Suppository formulation and manufacture
Bibliography
Websites
GATTEFOSSE, Hemisynthetic glycerides for suppositories and ovules with solid or liquid active ingredients, Internet http://www.gattefosse.com/fr/applications/?voie-d-administration,rectale-et-vaginale (page consultée le 11/06/2013)
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Norms and standards
- Classification biophamarceutique BCS - Pharmacopée Européenne 7.0 - . 2012
Patents
STEVENSON (W.G) and MACKINNON (W.E.) (5-2-1952) US Patent US 2,584,166, Deposited it 25-5-1948, Suppository.
SCHLUETER (K.W.) and SCHULTZ-KAISER (E.) (24-4-1979) US Patent US 4,151,274, Deposited it 15-11-1976, Process and composition for the production of suppositories.
GOYAN (J.E.) and WRABLE (M.) (14-3-1961) US Patent US 2,975,099, Deposited it 25-6-1958, Polyethylene glycol...
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
Dow for polyethylene glycols http://www.dow.com/polyglycols/polyethylene/products/carbowaxp.htm
Gattefossé for suppositories http://www.gattefosse.com/fr/applications/?voie-d-administration, rectal and vaginal masses
Cremer oleo for suppository masses http://www.cremeroleo.de/en/produktbereiche/cremer-health/index.php...
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