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• Misoprostol, is a life saving medication used to prevent and treat stomach ulcers, start labor, cause an abortion, and treat postpartum bleeding due to poor contraction of the uterus
• For abortions it is used by with mifepristone or methotrexate
• Misoprostol is taken by mouth when used to prevent gastric ulcers in persons taking NSAIDs.
• For labor induction or abortion, it is taken by mouth, dissolved in the mouth, or placed in the vagina and for postpartum bleeding it may also be used rectally.
• Misoprostol 1% HPMC Dispersion is a freely flowing white to off-white powder. Resulting from the stability that HPMC renders Misoprostol, the product in its dispersion form (Misoprostol 1% HPMC Dispersion) is comparatively stable. It is recommended to store in a cool place (less than 5°C) and protect from humidity and light for long-terms storage.
• Misoprostol, is a life saving medication used to prevent and treat stomach ulcers, start labor, cause an abortion, and treat postpartum bleeding due to poor contraction of the uterus
• Being unstable oil in nature and the formulations available in form of solid dosage forms, it is commercially being made available in form of bulk dispersion in HPMC (Confirming to USP) standards with 1% w/w of Misoprostol. The dispersed product shows better stability and efficiency in form of tablet processing.
• The Misoprostol oil synthesized by us before dispersion is analysed and passed as per USP specification.
• Misoprostol is available in form of its 1% dispersion in Hypermellose specially designed for easy tablet formulation of 200 mcg and 400 mcg.
• The product is available as per USP grade and provides excellent bioavailability and dissolution in the tablet form.
• Pellcaps is one of the prime manufacturers of this product in India and supplies to reputed Indian pharmaceutical companies and exports globally.
• Misoprostol is a difficult molecule to handle owing to its gummy liquid nature, stability issues pertaining to epimerization and temperature control.
• Pellcaps has a dedicated plant for manufacturing misoprostol which is designed to handle its high potent nature.
• The process is conducted under strict control conditions to ensure product stability and preventing cross contamination as well as exposure to the workers.
• The process involves using high quality excipients (HPMC) which is specifically designed to ensure uniformity and proper flow to enhance tablet manufacturing process.
• The Quality is controlled with dedicated process control systems and a stand alone testing facility.
• The packing is under nitrogen to ensure that oxidation and moisture levels are strictly controlled.
• The material is delivered under temperature controlled systems as per the USP guidelines.
• Product available in the market comes with varied assays creating difficulties in tableting as the dosage form is 200 mcg.
• Pellcaps provides perfect composition on w/w basis so as the strength in the formulation can be strictly controlled.
• Our product has been demonstrated to be stable in acute conditions at the RM level itself and in the finished dosage form the stability does not reduce. Product stability has been a constantly bothering issue for manufacuters of Misoprostol tablets.
• Pellcaps provides consultancy for manufacturing misoprostol dosage forms and helps its customers to develop stable formulation.
• Dedicated HPAPI handling facility.
• Dedicated utilities.
• State of the art testing facilities with
-HPLCs
-UV
-IR spectrophotometers
-Karl fisher titrators.
Pellcaps India
Location: 1 Km Suketi Road, KalaAmb Tal Nahan, Dist. Sirmour, Himachal Pradesh 173030
Webiste: www.pellcapsindia.in
Email: [email protected]
Commercial Manufacturing August 2019
Validation batches since: Oct 2018
• Complete Technical dossier available.
• cGMP.
Pack Sizes
-1 Kg
-2 Kg
-5 Kg
-8 Kg
To become the most preferred Pharmaceutical company in manufacturing and supply of customized pellets servicing Global markets with quality products.
H.O. A407, Anjani Complex, Opp. Guru Nanak Petrol Pump, Andheri East, Mumbai-400099, Maharashtra, India
Mobile: +91-9820013108, 9322228530
Email:[email protected], [email protected]
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