Acetylsalicylic Acid, also known by trade name Aspirin, is an acetyl derivative of salicylic acid that is a white, crystalline, weakly acidic substance, with melting point 137°C. It is useful in the relief of headache and muscle and joint aches. Aspirin is also effective in reducing fever, inflammation, and swelling and thus has been used for treatment of rheumatoid arthritis, rheumatic fever, and mild infection. Large doses cause acid-base imbalance and respiratory disturbances and can be fatal, especially in children. Acetaminophen (known by trade name Tylenol), which does not cause gastric irritation but does lower fever and relieve pain, is often substituted for Aspirin.

Chewing chewable tablets of aspirin produces the most rapid and biggest absorption compared to swallowing solid tablets or chewing and then swallowing solid tablets.

Formulation of Aspirin Chewable Tablet

Aspirin Chewable Tablet per Tablet
AlOH (Dried gel)          6.5 %       13 mg
Aspirin                          40.5%      81 mg
Talc                              1%            2 mg
Primogel                        4%            8 mg
NuTab                           46.7%     93.4 mg
Mafco Magna Sweet      0.3%       0.6 mg
Orange Flavor                1 %          2 mg


Preparation an Manufacturing
1. Mix NuTab and AlOH, add aspirin and mix again (1)
2. Mix primogel, talc, flavor, and Magna Sweet and sifted 16 mesh (2)
3. Add (2) to (1), mix and press into tablet

Combination NuTab and Magna Sweet as a sweetener to reduce the sour taste of aspirin, as well as the orange flavor. In the dry state, there is no incompatibility between aspirin reaction with alkaline AlOH. Primogel (Sodium Starch Glycolate) used as disintegrant and Talc as antiadherent.

Pre-Formulation
ASPIRIN
Physical State : white crystalline powder or needle-shaped crystals with sweetish taste, Odorless, Colourless
Melting Point : 136 C (with decomposition)
Boiling Point : 140 C
Specific Gravity : 1.35
Solubility : Soluble in acetone, ether, alcohol, boiling water, benzene and turpentine, sparingly soluble in chloroformbenzene, slightly soluble in water; melts at 158°C.
Solubility In Water: 1g/100g water @ 37C
Stability : Stable in dry air (hydrolyzes in moist air, decomposes in hot water)

Aspirin is unstable in the presence of alkaline compounds, such as alkaline stearate lubricants. Its replacement could be used talk.

The sodium salt form (sodium salicylate) is common commercially, prepared from mainly sodium phenolate with carbon dioxide under heating and pressure. It contains both a hydroxyl and a carboxyl group, which react with either an acid or an alcohol. The carboxyl group forms esters with alcohols; e.g. methyl salicylate is formed with methanol, which used in food flavorings and preservatives; menthyl salicylate is formed with methanol, which is used in suntan lotions. The hydroxyl group reacts with acetic acid to form acetylsalicylic acid (called aspirin) which is the most widely common antiseptic and antipyretic agent. Phenyl salicylate (called salol) is formed with phenol, which is also used as an antiseptic and antipyretic agent.

NU-Tab (Compressible Sugar)
is used in a wide range of chewable applications, including children's vitamins and medications and for taste masking bitter or unpleasant drugs.
Description: White, granular, free-flowing powder with the sweet taste of sucrose. Very soluble in water, non-hygroscopic, non-reactive with other tablet ingredients. Slightly soluble in alcohol. Nutritional information: 100% carbohydrate with a caloric content of 4 kcal/g.

Physical Characteristics:
Moisture Content (%) : NMT 1%
Bulk Density (g/cc) 0.69
retained on US 40 mesh: NMT 1%
retained on US 100 mesh: NMT 90%
through US 200 mesh: NMT 5%

Applications:
• In Chewable Tablet : coarse mesh size makes it an excellent carrier for materials with compresion problems
• In Direct Compression : excellent flowability, high compressibility, low hygroscopicity, sweet and non-reactive.
• Sweetener
• Taste Masking

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