Overview
Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established; the promotion of urinary excretion of toxic substances; as an Antiglaucoma agent; and as a renal function diagnostic aid. On October 30, 2020, mannitol was approved by the FDA as add-on maintenance therapy for the control of pulmonary symptoms associated with cystic fibrosis in adult patients and is currently marketed for this indication under the name BRONCHITOL® by Chiesi USA Inc.
Indication
Used for the promotion of diuresis before irreversible renal failure becomes established, the reduction of intracranial pressure, the treatment of cerebral edema, and the promotion of urinary excretion of toxic substances. Mannitol is also indicated as add-on maintenance therapy for improving pulmonary function in cystic fibrosis patients aged 18 and over who have passed the BRONCHITOL tolerance test (BTT). It is recommended that patients take an orally inhaled short-acting bronchodilator 5-15 minutes prior to every inhaled mannitol dose.
Associated Conditions
- Acute Renal Failure (ARF)
- Cystic Fibrosis (CF)
- Edema of the cerebrum
- Increased Intra Ocular Pressure (IOP)
Research Report
An Expert Monograph on Mannitol: Chemistry, Pharmacology, and Clinical Applications
1. Drug Identification and Overview
1.1. Introduction to Mannitol
Mannitol is a small molecule drug, classified chemically as a six-carbon sugar alcohol, or polyol.[1] It is a versatile and critically important agent in modern medicine, primarily functioning as a potent osmotic diuretic.[3] Chemically, it is a hexahydric alcohol related to the sugar mannose and is a stereoisomer of sorbitol.[2] Its multifaceted utility spans a wide range of clinical scenarios. Therapeutically, it holds a vital role in emergency and critical care settings for the reduction of acutely elevated intracranial pressure (ICP) associated with cerebral edema and for lowering high intraocular pressure (IOP) in conditions like glaucoma.[1] It is also employed to promote diuresis in certain renal conditions, to facilitate the elimination of toxins, and as a diagnostic agent to measure kidney function.[1] In a distinct application, an inhaled formulation of Mannitol serves as an adjunctive therapy for managing the pulmonary symptoms of cystic fibrosis.[1]
Beyond its direct therapeutic roles, Mannitol is extensively utilized in the pharmaceutical and food industries. Its unique physicochemical properties, including chemical stability, non-hygroscopicity, and safety profile, make it a valuable pharmaceutical excipient in various dosage forms.[6] In the food sector, it functions as a low-calorie sweetener and texturizing agent.[4] The compound is identified by the DrugBank Accession Number DB00742 and the Chemical Abstracts Service (CAS) Registry Number 69-65-8.[1]
1.2. Chemical and Physical Profile
A thorough understanding of Mannitol's clinical and industrial applications begins with its fundamental chemical and physical characteristics.
Chemical Identity
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/07/28 | Phase 3 | Completed | |||
2020/06/11 | Phase 2 | Recruiting | |||
2020/05/19 | Phase 2 | Completed | Raphael Heinzer | ||
2020/05/12 | Phase 2 | Withdrawn | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | ||
2020/02/05 | Phase 2 | Completed | Phramongkutklao College of Medicine and Hospital | ||
2020/01/03 | Phase 3 | Recruiting | dr. M.J.N.L. Benders | ||
2019/12/05 | N/A | Completed | Tribhuvan University Teaching Hospital, Institute Of Medicine. | ||
2019/10/22 | Phase 1 | Active, not recruiting | Beijing Tiantan Hospital | ||
2018/06/29 | Phase 4 | Completed | |||
2018/04/23 | Phase 3 | Completed |
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