Bioequivalence and Bioavailability Forum • Food PH and fed study bioequivalence

Tina
★

India,
2016-12-12 12:40
(3128 d 20:59 ago)

Posting: # 16837
Views: 3,610

Food PH and fed study bioequivalence [Design Issues]

Dear all,

For fed bioequivalence study, we often talk about the high fat breakfast wiith individual protein, fat and carbohydrates' breakdown.

Does high fat breakfast pH( donno whether this can be measured) have any effect on the bioavailability? High fat breakfast differ considerably (on meal type) across the globe. For pH sensitive release products (delayed release and/or modified release, will food PH inaddition have any effect on bioequivalence?

I look forward to your reply.

Kind regards,
Tina

Dr_Dan
★★

Germany,
2016-12-12 12:59
(3128 d 20:40 ago)

@ Tina
Posting: # 16838
Views: 2,798

Food PH and fed study bioequivalence

Post reply

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.

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Kind regards and have a nice day
Dr_Dan