Food PH and fed study bioequivalence [Design Issues]
Dear Tina
Your stomach secretes hydrochloric acid, but the pH of your stomach isn't necessarily the same as the pH of the acid nor the pH of the ingested food. The pH of your stomach varies, from 1-2 up to 4-5. When you eat, the stomach releases enzymes = proteases as well as hydrochloric acid to aid in digestion. The proteases that cleave proteins work best in an acidic environment or low pH, so after a high-protein meal, your stomach pH may drop to as low as 1 or 2. However, buffers quickly raise the pH back to 3 or 4. So in case of pH sensitive release products it will not be the food PH intself that will have an effect on bioequivalence but a combination of many physiological factors influencing the stomach pH.
I hope this helps.
Your stomach secretes hydrochloric acid, but the pH of your stomach isn't necessarily the same as the pH of the acid nor the pH of the ingested food. The pH of your stomach varies, from 1-2 up to 4-5. When you eat, the stomach releases enzymes = proteases as well as hydrochloric acid to aid in digestion. The proteases that cleave proteins work best in an acidic environment or low pH, so after a high-protein meal, your stomach pH may drop to as low as 1 or 2. However, buffers quickly raise the pH back to 3 or 4. So in case of pH sensitive release products it will not be the food PH intself that will have an effect on bioequivalence but a combination of many physiological factors influencing the stomach pH.
I hope this helps.
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Food PH and fed study bioequivalence Tina 2016-12-12 11:40 [Design Issues]
- Food PH and fed study bioequivalenceDr_Dan 2016-12-12 11:59