Methods of designing an oral drug dosage form based on a target pk profile and dosage forms thereof

A method of designing an oral drug dosage form formulated and configured to provide a target pharmacokinetic (PK) profile for a drug in an individual, the method comprising:

• (a) determining a drug absorption rate profile based on deconvolution of a target PK profile using a disposition profile, and a total amount of a drug in the oral drug dosage form;
• (b) determining a drug absorption amount profile based on the drug absorption rate profile;
• (c) determining a drug concentration time or location profile based on the simulated drug absorption rate profile and a permeability time or location profile for the drug,
• (d) determining a GI drug requirement amount profile based on the drug concentration time or location profile and a GI liquid volume time or location profile;
• (e) determining a simulated drug release profile configured to obtain the target PK profile based on the drug absorption amount profile and the GI drug requirement amount profile,
• wherein the simulated drug release profile comprises an amount of the drug released from the oral drug dosage form to obtain the target PK profile;
• and
• (f) designing the oral drug dosage form to release the drug based on the simulated drug release profile thereby designing the oral drug dosage form formulated and configured to provide the target PK profile.

A method of making an oral drug dosage form comprising a drug formulated and configured to have a target pharmacokinetic (PK) profile, the method comprising three-dimensional (3D) printing the oral drug dosage form based on a design of the oral drug dosage form obtained from a method comprising:

• (a) determining a drug absorption rate profile based on deconvolution of a target PK profile using a disposition profile, and a total amount of a drug in the oral drug dosage form;
• (b) determining a drug absorption amount profile based on the drug absorption rate profile;
• (c) determining a drug concentration time or location profile based on the drug absorption rate profile and a permeability time or location profile for the drug, (d) determining a GI drug requirement amount profile based on the drug concentration time or location profile and a GI liquid volume time or location profile;
• (e) determining a simulated drug release profile configured to obtain the target PK profile based on the drug absorption amount profile and the GI drug requirement amount profile,
• wherein the simulated drug release profile comprises an amount of the drug released from the oral drug dosage form to obtain the target PK profile;
• and
• (f) designing the oral drug dosage form to release the drug based on the simulated drug release profile thereby designing the oral drug dosage form formulated and configured to provide the target PK profile.