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Factorial Design For Tramadol Extended Release Capsules Containing Microspheres
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UPLOADED BY-ADMIN, JAIKISHAN KHATRI, MUGDHA KARDE, SAVITA YADAV, DR. S.S. BHALERAO
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| Abstract:
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Tramadol Hydrochloride is a centrally acting analgesic and belongs to Class I Drugs as per the BCS classification. The halflife
of the drug is about 5.5 hours and the usual oral dosage regimen is 50 to 100 mg every 4 to 6 hours. Thus, it is necessary
to have an extended release preparation of Tramadol Hydrochloride. Currently, Tramadol HCl is available in the form of
both immediate and extended release tablets. Immediate release capsules are also available. However, extended release
capsules are not available. The objective of the present study is to formulate capsules containing microspheres in size zero
capsules. The polymer used in the current study is ethyl cellulose N 50. A 32 full factorial design has been carried out using
Design Expert 8.0 software. The Drug: Polymer ratio and Speed (rpm) of the stirrer represent the independent factors and the
particle size, entrapment efficiency and similarity factor represents the dependent factors. Microspheres were prepared using
emulsion solvent evaporation method. The resultant microspheres were evaluated for particle size, entrapment efficiency and
in-vitro dissolution. The entrapment efficiency was found to be between 80 to 87 %. The results of the factorial design
indicated that the concentration of ethyl cellulose and stirring speed affected the particle size, entrapment efficiency and
similarity factor. One of the formulations of the design (F4) showed a closest profile to the Tramadol Hydrochloride Tablets
marketed preparation with a similarity factor of 64. The model fitting of the in-vitro data revealed that the formulation
followed zero order release kinetics.
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| Keyword:
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Ethyl cellulose, Extended Release, Factorial Design, Microspheres, Tramadol Hydrochloride.
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