Paracetamol or also known as Acetaminophen has been very well known as analgesic and antipyretic drug. Actually, this tablets were sold as OTC drug or even prescribed by doctors with high value of prize. Don’t you know, it’s easy to make and all ingredients were easy and cheap to purchased.
It is well known that paracetamol exhibits poor compressibility during compaction, often resulting in weak and unacceptable tablets with a high tendency to cracking and sticking.
The active ingredients, paracetamol, is easy to purchased, so does the other ingredients. The ingredients used to produced paracetamol tablets are:
- Paracetamol/Acetaminophen ( Active ingredients)
- Maize Starch (Binder)
- Croscarmellose (Desintegrant)
- Nipagin/Methyl Paraben (Preservative)
- Nipasol/Propyl Paraben (Preservative)
- Purified Water
- Talc (antisticking)
- Silicon Dioxide Colloidal (antiadherent)
- Magnesium Stearate (Lubricants)
- Paracetamol/Acetaminophen ( Active ingredients) 500 mg
- Maize Starch (Binder) 5% w/w 42.5 mg
- Croscarmellose (Desintegrant) 3% w/w 25.5 mg
- Nipagin/Methyl Paraben (Preservative) 0.03% w/w 0.255 mg
- Nipasol/Propyl Paraben (Preservative) 0.07% w/w 0.595
- Microcrystalline Cellulose (Filler) 10% w/w 170 mg
- Purified Water
- Microcrystalline Cellulose 102 (Filler)qs ad 94.15 mg
- Talc (antisticking) 0.5% w/w 4.25 mg
- Silicon Dioxide Colloidal (antiadherent) 1% w/w 8.5 mg
- Magnesium Stearate (Lubricants) 0.5% w/w 4.25 mg
• Weight per tablet : 850 mg
• Diameter tablet : 10 mm
• Hardness tablet : 8-10 kg/cm2
Preparations of Paracetamol tablet using wet granulation:
- Prepare and weight all ingredients, then sieve it with mesh 20 except magnesium stearate sieve it with mesh 30.
- Make Maize paste: Prepare ± 42.5 ml (aa with the maize starch). Pour it into the maize starch and stir it well. Prepare hot water ± 127.5 ml (3 x the amount of maize starch). The dissolve nipagin and nipasol using this hot water, until completely homogenous. Then, pour it together to the maize starch, stir it well until formed paste.
- Wet granulation: Mix sieved paracetamol, microcrystalline cellulose 102, and croscarmellose until homogenous. Then, granulate it with maize paste. You can add purified water qs to make a well mass. Sieve it using mesh 4.
- Drying Process: Dry the mass using oven or Fluid Bed Dryer, until moisture content ± 1-2.5%. After the granule dry, sieve it again through mesh 12 and sieve it again through mesh 20.
- Outher Phase : Add Microcrystalline Cellulose, Talc, and Silicon Dioxide Colloidal, mix it about 10 minutes
- Lubricants : Add magnesium stearate and mix it again about 3 minutes
- Tablet compression: Compress the mass using rotary tablet machine, appropriate with the tablet specification.
- Manufacturing and Formulation of Paracetamol Syrup (Free Alcohol) for Children
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