Patient-centric solid oral dosage forms.

 Introduction:
Medication adherence is a growing concern for public health and poor adherence to
therapy has been associated with poor health outcomes and higher costs for
patients. Interventions for improving adherence need to consider the characteristics
of the individual therapeutic regimens according to the needs of the patients.
Industries play a crucial role in keeping the innovation cost at a minimum level to
reduce the patients’ financial burden. Patient-Centric Drug Product
Pharmaceutical Design (PCDPD) offers the opportunity to meet the needs and
preferences of patients. It simply involves understanding patients’ needs and
allowing them to receive the most appropriate treatment at a reasonable cost.
According to the World Health Organization (WHO), patient-centric formulations are
becoming essential for public health when dealing with long-term diseases treated
with multiple drugs. However, data related to the understanding of dosage form-
related issues in medication acceptability are lacking. Therefore, the development of
advanced technologies has resulted in significant efforts to develop customizable
dosage forms.

 Patient-centric pharmaceutical drug product design:

Patient-centric pharmaceutical drug product design (PCDPD) can be defined as the
“process of identifying the comprehensive needs of individuals or the target patient
population and utilizing the identified needs to design pharmaceutical drug
products that provide the best overall benefit to risk profile for that target patient
population over the intended duration of treatment”
The capability of the patients to manage complex medication is very limited and may
have to rely on caregivers. There are chances of a higher incidence of medication
errors and poor adherence for cases where patients do not feel comfortable with
their drug regimens. Therefore, patient-centric pharmaceutical drug product design
plays a crucial role in developing or designing pharmaceutical products according to
patients’ needs. To generate a patient-centric basis for guidance during
pharmaceutical development, a system composed of design drivers, design inputs,
and design outputs can be implemented. The design drivers and design inputs are
derived from the targeted patient population and can be identified through routine
check-ups (e.g., geriatric assessments). Subsequently, patients and healthcare
professionals (e.g., doctors, nurses, and pharmacists) must work together to identify
the most important design outputs and select the most suited pharmaceutical drug
product accordingly
  Understanding patient preferences and needs regarding treatment features is a key
element of the patient-centric design process. The different patient factors should be
considered and prioritized to achieve a more universal design, suitable for the
broadest patient population.
Patient-related characteristics are relevant for patient-centric pharmaceutical drug
product design.

Patient-Related
Examples
Characteristics
Age Organ and body functions, socioemotional status
Visual impairment Blindness
Motoric impairment Arm mobility, difficulty walking, manual dexterity
Swallowing impairment Dysphagia
Cognitive impairment Memory loss, dementia
Poor hand sensitivity Control of movement and strength
Loss of hearing
Dentition
Health literacy
Psychological distress Negative perception, depressive disorders
Disease state Comorbidities, disease disability
Way of living, Employment status, access to
Psycho-social issues
caregivers

By applying a patient-centric model increased attention will be given to the

packaging design and opening mechanism during the development of
pharmaceutical products.

 Patient-centric pharmaceutical solid oral dosage forms.

 Over the years, research and development activities in academic, pharmaceutical,
and research organizations have contributed to new innovative products. This has
led to a constant increase in the number of novel dosage forms and formulation
technologies available to the patients. Nevertheless, the majority of drug products
available on the market remain solid oral dosage forms. For drugs that can be
delivered orally, solid oral dosage forms are and will continue as the main drug
delivery technology due to their technological applications, which can be applied or
adapted to meet patients’ needs (e.g., taste masking and extended-release). In
addition, the development and manufacturing of solid oral dosage forms are very
well established in the pharmaceutical industry and it is the technology of choice
whenever applicable due to its cheaper price.
Concerning solid oral dosage forms, the subject of patient-centric pharmaceutical
drug product design will focus more on the customization of existing technologies to
address the needs of specific patient populations such as pediatrics, geriatrics,
dysphagia patients, or mentally ill patients.

In pediatric patients, there is often a fear of choking during the administration of the
dosage form, whereas mentally ill patients often skip their medications by hiding the
dosage form in their cheeks. Considering geriatric and dysphagia patients, there is a
general difficulty to swallow related to a deterioration of the swallowing function due to
aging, specific diseases, or co-morbidities, which challenges the oral administration of
drug products.
The introduction of new European Medicine Agency (EMA) guidelines addressing the
development of appropriate medicines for the pediatric population led to a general
understanding that solid oral dosage forms such as multiparticulate and minitablets
are suitable patient-centric options, enabling proper administration, flexible
dosing, and high acceptability in young children. Since older patients tend to present an
aged and deteriorated swallowing function (dysphagia), they may also struggle to
swallow large tablets and capsules. Therefore, the patient-centric approach currently in
development for the pediatric population can also be transferred to the geriatric
population, as these patients would benefit from solid oral dosage forms such as
minitablets or multiparticulate systems to facilitate oral drug administration and
increase the efficacy and safety of prescribed treatments by reducing the cases of drug
product manipulation to improve swallowability.
For cases of drug products that remain in a conventional tablet or capsule presentation
(e.g., high drug loads), a patient-centric approach could involve the development of
appropriate surface conditions that can aid the swallowability and gliding properties of
tablets and capsules during oro-esophageal transit. This can be obtained through the
development of new coating technologies that present poor mucoadhesive properties
and increased gliding performance across the oro-esophageal system.

 Multiparticulate technology:
Multiparticulates, which consist of multiple discrete drug-containing particles that
together make up a single dose, is an emerging technology particularly well-suited for
pediatric applications because they meet the majority of these considerations.
Advantages of multiparticulate-
 Safe swallowability
 Taste masking
 High dose flexibility
 Accuracy of the administered dose
Multiparticulates can be called particles, pellets, mini-tablets, microspheres, granules,
and beadlets and are made using processes including melt-spray congealing (MSC),
extrusion-spheronization, tableting, and fluid-bed coating.
By applying a patient-centric
model, increase attention would be
given to the packaging
design and opening mechanism
during the development of the
pharmaceutical product.
By applying a patient-centric
model, increase attention would be
given to the packaging
design and opening mechanism
during the development of the
pharmaceutical product.
By applying a patient-centric
model, increase attention would be
given to the packaging
design and opening mechanism
during the development of the
pharmaceutical product.
By applying a patient-centric
model, increase attention would be
given to the packaging
design and opening mechanism
during the development of the
pharmaceutical product. e
Some of the marketed multiparticulate preparations :

 Fixed-dose combinations:
 A fixed-dose combination (FDC) has been developed to reduce the pill burden for
patients. By reducing the overall pill burden and simplifying medication regimens, fixed
combinations have been shown to improve medication adherence and persistence in
several studies.
Today, numerous FDCs exist on the market and are widely recognized as safe and
effective. For this reason, many chronic conditions can benefit from this kind of
therapeutic approach to reduce pill burdens, such as dyslipidemia, atherosclerosis,
hypertension, osteoporosis, heart failure, post-myocardial infarction, angina, type 2
diabetes, chronic obstructive respiratory disease, and HIV 
The capability of these patients to
manage com-
plex medication is very limited and
may have to rely on care-
givers [33]. This is a predictor for a
higher incidence of med-
medication errors and poor
adherence for cases where patients
do
not feel comfortable with their
drug regimens [34–36].
Therefore, patient-centric
pharmaceutical drug product design
plays a crucial role in developing or
designing pharmaceutical
products according to patients’
needed
The capability of these patients to
manage com-
plex medication is very limited and
may have to rely on care-
givers [33]. This is a predictor for a
higher incidence of memedicationion
errors and poor adherence for cases
where patients do
not feel comfortable with their
drug regimens [34–36].
Therefore, patient-centric
pharmaceutical drug product design
plays a crucial role in developing or
designing pharmaceutical
products according to patients’ needs
Use of 3D printing technology in manufacturing Patient-centric
dosage forms:
ZipDose technology is the brand name of Aprecia’s 3DP manufacturing technology
related to the formulation of advanced fast melt dosage forms. The name does not refer
to the manufacturing process or machinery but instead relates to the resulting
formulations themselves.

ZipDose® Technology is Aprecia’s first proprietary platform that enables the

production of high-dose, fast-melt tablets designed for ease of swallowing with just a sip
of liquid, as utilized in Spritam® (levetiracetam). ZipDose® can be used to create
rapidly disintegrating oral dosage forms with features such as:

 Delivering ultra-low or high drug loads – even for doses beyond 1,000mg of
active pharmaceutical ingredient – an unprecedented range for any other fast
melt technology available today
 Ease of swallowing & administration with no liquid measuring required
 Diverse patient compliance benefits such as taste masking and modified-release
capabilities via engineered and coated particles
Aprecia’s additive and compression-free manufacturing approach enable the
flexibility, precision, & freedom to design unique, patient-centric medications
unachievable through traditional methods.

Conclusion:
The adoption of patient-centric care is expected to benefit patients and contribute to
huge savings in healthcare costs. Through a solid commitment of all parts involved,
patients will be highly engaged in their therapeutic choices, as these will appropriately
address their specific needs. This will contribute to higher adherence levels and reduced
events of medication errors or potential adverse drug reactions, which eventually
reflect less number of hospitalizations.

References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7023035/
https://drug-dev.com/multiparticulate-formulations-using-multiparticulate-
technology-to-develop-pediatric-drug-products/
https://www.pharmaexcipients.com/aprecia/
https://www.researchgate.net/publication/
336460900_Future_Perspectives_for_Patient-
Centric_Pharmaceutical_Drug_Product_Design_with_Regard_to_Solid_Oral_Dosage
_Forms

Snehal khankal
TY B. Pharm student
Oriental college of pharmacy.

The capability of these patients to

manage com-
plex medication is very limited and
may have to rely on care-
givers [33]. This is a predictor for a
higher incidence of med-
medication errors and poor
adherence for cases where patients
do
not feel comfortable with their
drug regimens [34–36].
Therefore, patient-centric
pharmaceutical drug product design
plays a crucial role in developing or
designing pharmaceutical
products according to patients’
To address these issues and reduce
healthcare costs, fun-
damental changes need to be made in
how healthcare providers-
sion is administered to patients,
which raises the opportunity
for the implementation of patient-
centric systems
To address these issues and reduce
healthcare costs, fun-
damental changes need to be made in
how healthcare providers-
sion is administered to patients,
which raises the opportunity
for the implementation of patient-
centric systems
To address these issues and reduce
healthcare costs, fun-
damental changes need to be made in
how healthcare providers-
sion is administered to patients,
which raises the opportunity
for the implementation of patient-
centric systems
To address these issues and reduce
healthcare costs, fun-
damental changes need to be made in
how healthcare providers-
sion is administered to patients,
which raises the opportunity
for the implementation of patient-
centric systems
To address these issues and reduce
healthcare costs, fun-
damental changes need to be made in
how healthcare providers-
sion is administered to patients,
which raises the opportunity
for the implementation of a patient-
centric system Patient-Centric Drug Product
Pharmaceutical Design (PCDPD) offers the opportunity to meet the
needs and preferences of patients.