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  • Children's Hospital of Eastern Ontario Master Formula Sheet - Non-Sterile Manufacturing PRODUCT: Baclofen 5 MG/ML Oral Suspension

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    David Hosam
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    This document provides instructions for creating a 5 mg/ml oral suspension of the drug baclofen using commercially available 10 mg tablets as the drug source. It lists the ingredients, their manufacturers and lot numbers, quantities used, equipment needed, and manufacturing directions. The final product is stable for 35 days when refrigerated in an amber glass container. References and revision history are also provided.

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    This document provides instructions for creating a 5 mg/ml oral suspension of the drug baclofen using commercially available 10 mg tablets as the drug source. It lists the ingredients, their manufacturers and lot numbers, quantities used, equipment needed, and manufacturing directions. The final product is stable for 35 days when refrigerated in an amber glass container. References and revision history are also provided.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
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    7 views1 page

    Children's Hospital of Eastern Ontario Master Formula Sheet - Non-Sterile Manufacturing PRODUCT: Baclofen 5 MG/ML Oral Suspension

    Uploaded by

    David Hosam
    This document provides instructions for creating a 5 mg/ml oral suspension of the drug baclofen using commercially available 10 mg tablets as the drug source. It lists the ingredients, their manufacturers and lot numbers, quantities used, equipment needed, and manufacturing directions. The final product is stable for 35 days when refrigerated in an amber glass container. References and revision history are also provided.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
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    Children's Hospital Of Eastern Ontario MASTER FORMULA SHEET NON-STERILE MANUFACTURING PRODUCT:

    Date Prepared: EXPIRY DATE: INGREDIENT MANUFACTURER LOT # MAN. EXPIRY DATE FORMULA QUANTITY 30 QUANTITY USED MFG BY CHK BY

    Baclofen 5 mg/ml Oral Suspension


    FINAL PRODUCT CHECKED BY: _____________________

    Baclofen 10 mg tablets

    APOTEX

    Glycerin Liquid Simple Syrup Paddock STABILITY

    3 ml Qs to 60 ml

    EQUIPMENT - mortar and pestle - graduated cylinder - oral syringe to measure glycerin MANUFACTURING DIRECTIONS - Place tablets into mortar and grind into a fine powder with pestle - Add enough glycerin to make a fine paste - Gradually add about 45 ml (2/3 of the total volume needed) of simple syrup in 3 equal additions, mixing well each time - Transfer suspension to the cylinder and QS to the final volume

    Refrigerated, 35 days Amber glass container

    REFERENCE(S) Am J Health-sys Pharm. 1993; 50:2353-55 Alberta Health Services Formula, accessed Nov 2011 Hospital for Sick Children formula , accessed Nov 2011 Re-formulated Nov 2011 as the 10 mg/ml was very thick and unpleasant

    Revision Dates: Nov 2011_ Final Approval By: ab_/cm Signatures: ab_/cm
    C:\Documents and Settings\mpaladeau\Local Settings\Temporary Internet Files\OLK33\baclofen 5 mg per ml suspension.doc

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