Nitroglycerin 2.6mg

Empress SR

Technically Empress SR is a Carbomer. This grade of carbomer is Benzene Free grade used in oral preparations, in suspensions, tablets, or sustained release preparation. In tablet formulations,

FormulationClaim per tabFunction
Ingredient
Mixing:
Nitroglycerin26 mgActive Pharmaceutical Ingradient
MCCp 10274.0 mgFiller
Empress SR50 mgSustained release polymer
PVPk3015 mgBinder
Aerosil1 mgGlident
IPAQsVehicle
Talc2 mgLubricant
Magnesium stearate2 mgLubricant
Empress SR15 mgSustained release polymer
Aerosil1 mgGlident
Empress SR5 mgSR material

Physical properties of tablets

Avg. Weight-140mg
Hardness-5-6kg/cm2

Procedure

    • Mixing:
      1. Pass Nitroglycerin and MCCPH102, Empress SR through 60 # in sifter
      2. mix it insuitable blender for 15 mins.
    • Binder Preparation and Binding:
      1. Dissolve PVPK30 in IPA and prepare clear solution
      2. Now bind the Premix using binder prepared in Step 1 and if necessary add additional IPA to get a wet mass ,
      3. Pass the weight mass through #12 sieve to get uniform wet granules and dry it at inlet temp of 40o c
      4. Now size the granules using #30 to get dry granules
    • Lubrication:
      1. Collect the dried granules in blender
      2. Sift the material Talc, EmpressSR, Mg Stearate and Aerosil with #60 sieve.
      3. Mix the lubricants in Dried granules and compress the tablet with following parameter

Dissolution study

Apparatus : Paddle [Apparatus-2]

Medium : pH 6.8 Phosphate Buffer

Quantity : 900 ml

RPM : 50

Temp : 37±1oC

HOURS1st4th8th12th
% Release15%47%76%91%
LimitNMT 20%25-45%50-80%NLT 85%

Note :

  1. This is the tentative formulation and the information is based on laboratory work with small scale equipment and does not indicate the product performance.
  2. Full scale testing and end product performance are the responsibility of the user.
  3. We suggest that you may be increase or decrease the quantity of polymer and types of Excipients according to your final formulation/requirements.