Sugar Free Gold

• Use as a low-calorie artificial sweetener:
  Approved as a sugar substitute in foods and beverages for individuals seeking to reduce caloric intake or control blood glucose levels.
• Suitable for:
• Patients with diabetes mellitus requiring sugar-free alternatives.
• Individuals managing weight or obesity.
• Off-label/less common uses:
• Used in some pharmaceutical formulations to mask bitter tastes.

• Typical consumption:
• The Acceptable Daily Intake (ADI) is set at 40 mg/kg body weight/day (European Food Safety Authority) or 50 mg/kg/day (FDA).
• This translates roughly to about 18–19 cans of diet soda per day for an average adult, which is well above normal consumption levels.
• Administration:
• Administered orally as part of food, beverages, or oral pharmaceutical products.
• No dosage adjustments necessary for age, renal or hepatic impairment.

Aspartame is a methyl ester of a dipeptide composed of aspartic acid and phenylalanine. Upon ingestion, it is rapidly hydrolyzed in the gastrointestinal tract to its constituent amino acids and methanol. The sweet taste arises from its binding to sweet taste receptors on the tongue (T1R2 and T1R3 receptors), stimulating sweetness perception without providing significant calories. The amino acid components are metabolized normally by the body and utilized in protein synthesis or energy metabolism.

• Absorption:
  Rapid hydrolysis in the gut to phenylalanine, aspartic acid, and methanol.
• Distribution:
  Phenylalanine and aspartic acid enter systemic circulation and cross the blood-brain barrier.
• Metabolism:
• Phenylalanine participates in protein synthesis and neurotransmitter precursor pathways.
• Aspartic acid is metabolized via transamination pathways.
• Methanol is oxidized to formaldehyde and formic acid, which are further metabolized and excreted.
• Elimination:
  Metabolites are excreted primarily via urine and carbon dioxide through respiration.
• Half-life: Not applicable as aspartame itself is rapidly hydrolyzed.

• Pregnancy:
  Classified as pregnancy category B (FDA) — animal studies have shown no harm; human data are limited but generally considered safe when consumed within ADI.
• Lactation:
  Aspartame and its metabolites are not known to accumulate in breast milk; considered safe at normal dietary levels.

• Artificial non-nutritive sweetener

• Phenylketonuria (PKU):
  Individuals with PKU must strictly avoid aspartame due to phenylalanine content, which can accumulate and cause neurotoxicity.
• Known hypersensitivity to aspartame or any formulation excipients.

• Monitor individuals with phenylketonuria; product labeling must indicate phenylalanine content.
• Caution in patients with rare hereditary problems of fructose intolerance or other metabolic disorders if co-formulated with other sweeteners.
• Excessive consumption may cause headaches or gastrointestinal discomfort in sensitive individuals.

• Common:
• Rare reports of headache, dizziness, or gastrointestinal upset in sensitive individuals.
• Serious/Rare:
• Hypersensitivity reactions are very rare.
• No confirmed evidence of carcinogenicity or neurotoxicity at recommended intake.
• Timing:
• Symptoms usually occur shortly after ingestion in sensitive individuals.

• No significant drug interactions reported.
• No effect on blood glucose or insulin, so safe to use with antidiabetic medications.
• No known CYP450 involvement.

• Regulatory agencies including FDA, EFSA, and WHO confirm safety at current ADI levels.
• Continuous post-marketing surveillance has not demonstrated new safety concerns.
• Products containing aspartame must declare phenylalanine content for consumer awareness, per labeling regulations.

• Store in a cool, dry place away from direct sunlight.
• Temperature range: Typically room temperature (20°C to 25°C).
• Protect from moisture to maintain product stability and sweetness.
• No refrigeration needed.
• Keep out of reach of children.