In the pharmaceutical industry, Dicyclomine Hydrochloride 20 mg is a synthetic antispasmodic and anticholinergic agent. As a pharmacist, I characterize this as a “smooth muscle relaxant” that specifically targets the gastrointestinal tract to alleviate cramp-like pain.
Primary Clinical Uses
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Irritable Bowel Syndrome (IBS): Used to treat the functional symptoms of IBS, such as abdominal pain, bloating, and irregular bowel movements.
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Gastrointestinal Spasms: Relieves acute spasms of the GI tract caused by various functional disorders.
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Colic: In specific cases (and often in lower doses or different formulations for pediatrics), it is used to manage infant colic, though its use in infants is highly restricted due to safety profiles.
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Adjunctive Therapy: Often used alongside other treatments for peptic ulcers or enterocolitis to reduce the pain associated with hypermotility.
Mechanism of Action
Dicyclomine works through a dual-action pathway to relax the gut:
Antimuscarinic Action: It competitively blocks acetylcholine at the muscarinic receptors ($M_3$ subtype) located on the smooth muscle of the gastrointestinal tract. By blocking these signals, it stops the involuntary muscle contractions (spasms).
Direct Spasmolytic Effect: It also has a direct effect on the smooth muscle itself, independent of the nervous system, which helps ensure the muscle remains in a relaxed state.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Dicyclomine 20 mg is a high-demand “GIT specialty” product:
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Fixed-Dose Combinations (FDCs): As a WHO-GMP manufacturer, we often formulate Dicyclomine with Paracetamol or Mefenamic Acid (e.g., for menstrual or spasmodic pain). The technical challenge is maintaining the stability of Dicyclomine in these multi-API matrices.
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Bioavailability & Assay: We adhere to strict BP/USP/IP monographs, ensuring that the 20 mg dose is released uniformly. We utilize validated dissolution testing to guarantee that the drug acts quickly once ingested.
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Packaging for Export: Dicyclomine is sensitive to environmental degradation. We utilize PVC/PVDC or Alu-Alu blister packaging to ensure a stable 36-month shelf life, particularly for export to Zone IVb regions like Africa and Southeast Asia.
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Regulatory Compliance: Our Mumbai-based facility provides comprehensive CTD/eCTD Dossiers to support international B2B registration and hospital tenders.