Patient-Centric Drug Product Design

Patient centricity

the specific needs of an individual patient or distinct patient populations as the focal point in pharmaceutical drug product design

patient-based considerations

age (peds/elderly particularly)

allergies/sensitivities

cognitive function

other dietary restrictions

visual impairment

motor restriction

Dosage forms: physical and chemical properties

particle size, solubility, dissolution, partition coefficient, ionization constant, crystal properties

Dosage forms: biopharmaceutical considerations

how the physicochemical properties of the drug, dosage form and route of admin affect rate and extent of absorption

Dosage forms: therapeutic considerations

clinical condition to be treated and patient population, comorbidities, polypharmacy

Acceptability of dosage forms

the overall ability and willingness of the patient to use and caregiver to administer the medicine as intended

Ozempic

GLP-1 analog (semaglutide injection)

89% bioavailability

once weekly subcutaneous injection

Combination product

pairs a device with a drug or biological product. Products that are physically or chemically combined

Interface design

how the patient interacts with the product interface, including inner and outer packaging, label, instructions, device, controls, and displays

Rybelsus

bioavailability 0.4% to 1%

take at least 30 minutes before first food, beverage or other oral meds of the day

take with no more than 4oz plain water

formulated with SNAC

SNAC (salcaprozate sodium)

intestinal permeation enhancer

tablet erodes in the stomach, releasing concentrated amounts of SNAC that neutralizes the pH of gastric fluid in proximity of the tablet to inactivate pepsin

SNAC increases gastric membrane fluidity, but without affecting tight junctions, thus allowing transcellular passage of semaglutide

Induces the shift of semaglutide to predominantly monomeric state

Target product profile of product intended for the elderly

easy to swallow

easy to handle

packaging easy to open

easy to dose

low risk of excipient overload

fixed combinations

use of dosing devices

target product profile of product intended for pediatric patients

age appropriate dosage form

safe excipients

easy to swallow, dose, handle

good palatability

flexibility in dosing

user instruction

administration and dosing devices

product appearance

term newborn infants

0-27 days

infants and toddlers

28 days to 23 months

children

preschool children: 2-5 years

school children: 5-11 years

adolescents

12 - 16 or 18 years (depends on region)

oral solid dosage forms for peds or patients with dysphagia

chewable tablets

effervescent tablets

multiparticulates/granules

orodispersable tablets (ODTs)

Spritam

levetiracetam tablets

3D printed

highly porous tablet that rapidly disintegrates in the mouth with a sip of water

acceptability of liquid dosage forms

dose volume (< 5ml for children under 5) (< 10ml for children 5 or older)

organoleptic properties (taste, smell, texture, appearance)

minimum, non-toxic excipients