A Walnut’s guide to Pharmaceutics I: Maniac Edition
1. The drug and the excipients should be compatible
2. The product should be manufactured under appropriate
measurements of QC.
What are the requirements of a
drug product?
3. The product should be packaged in containers that contribute to
product stability.
4. The product should be labeled for correct use and to
be stored under conditions that contribute to maximum
shelf life.
Solids: Pharmaceutical Powders,
Capsules, Tablets Liquids: Solutions,
What are the general
classifications of a drug
Suspensions, Emulsions Semisolids:
product?
Creams, Ointments, Gels, Pastes,
Lotions
Miscellaneous: Aerosols, Patches, Other Advanced Systems
They are rarely administered alone, but as part of a
Are drug substances formulation in combination with one or more non-medical
administered alone? agents (ex: pharmaceutical ingredients, or additives or
excipients)
To solubilize, suspend, thicken, dilute, emulsify, stabilize,
What are the preserve, color, flavor, improve compressibility and modify
pharmaceutical dissolution to form various dosage forms.
ingredients/excipients there
for? Each dosage form is unique in its physical and pharmaceutical
characteristics
Broadly concerned with Formulation, Manufacture, Stability,
What is Pharmaceutics
concerned with? and Effectiveness of pharmaceutical dosage forms
An instrument, apparatus, appliance or material that has the
What is a Medical Device? purpose of diagnosis, prevention, monitoring, treatment or
alleviation of disease but does not achieve this by
pharmacological, immunological or metabolic means
, The physical manifestation of a drug as a solid, liquid, or gas
What is a Dosage Form?
that can be used in a particular way
Design feature of the dosage forms that affects the
What is Delivery System? delivery of the drug The means for transporting a
drug to its site(s) of action within the body
Could be a device used to deliver the drug
They differ in Pharmacological Properties such as sites of
How do Delivery Systems differ?
action, rate of delivery and quantities of active ingredient
delivered
Active ingredient to be delivered
Amount of active ingredient to be delivered
What does the choice of a
Delivery Systems depend
Means par route by which ingredient is to be delivered
on?
To what sites, at what rate, or what period of time, for what purpose
What are some therapeutic The nature of illness and the manner of treatment (local or systemic)
factors to consider for proper
dosage form selection?
Infants and children under 5 years old: Liquid Dosage forms are
preferred than solid
When an infant is vomiting, has productive cough, non-oral
measures may be employed
Some adults, especially the elderly have difficulty
How is patient age a
swallowing, so chewable tablets can be formulated
consideration for alternate
dosage forms?
Many medications for the elderly often are formulated into
oral liquids or orally disintegrating tablets
The elderly generally take MULTIPLE medications daily, so
making the solid forms shaped, sized or colored
distinctively will allow for proper identification. Dosage
forms that allow reduced frequency are also
advantageous
What happened in August 2015 3D tablets of Levateracetam (Spritam) was approved for
that paved ways for rapid disintegration of high- dosed drugs in the mouth
advanced formulation?
A Proprietary drug that has a trademark officially registered
What is a Brand Name?
1. The drug and the excipients should be compatible
2. The product should be manufactured under appropriate
measurements of QC.
What are the requirements of a
drug product?
3. The product should be packaged in containers that contribute to
product stability.
4. The product should be labeled for correct use and to
be stored under conditions that contribute to maximum
shelf life.
Solids: Pharmaceutical Powders,
Capsules, Tablets Liquids: Solutions,
What are the general
classifications of a drug
Suspensions, Emulsions Semisolids:
product?
Creams, Ointments, Gels, Pastes,
Lotions
Miscellaneous: Aerosols, Patches, Other Advanced Systems
They are rarely administered alone, but as part of a
Are drug substances formulation in combination with one or more non-medical
administered alone? agents (ex: pharmaceutical ingredients, or additives or
excipients)
To solubilize, suspend, thicken, dilute, emulsify, stabilize,
What are the preserve, color, flavor, improve compressibility and modify
pharmaceutical dissolution to form various dosage forms.
ingredients/excipients there
for? Each dosage form is unique in its physical and pharmaceutical
characteristics
Broadly concerned with Formulation, Manufacture, Stability,
What is Pharmaceutics
concerned with? and Effectiveness of pharmaceutical dosage forms
An instrument, apparatus, appliance or material that has the
What is a Medical Device? purpose of diagnosis, prevention, monitoring, treatment or
alleviation of disease but does not achieve this by
pharmacological, immunological or metabolic means
, The physical manifestation of a drug as a solid, liquid, or gas
What is a Dosage Form?
that can be used in a particular way
Design feature of the dosage forms that affects the
What is Delivery System? delivery of the drug The means for transporting a
drug to its site(s) of action within the body
Could be a device used to deliver the drug
They differ in Pharmacological Properties such as sites of
How do Delivery Systems differ?
action, rate of delivery and quantities of active ingredient
delivered
Active ingredient to be delivered
Amount of active ingredient to be delivered
What does the choice of a
Delivery Systems depend
Means par route by which ingredient is to be delivered
on?
To what sites, at what rate, or what period of time, for what purpose
What are some therapeutic The nature of illness and the manner of treatment (local or systemic)
factors to consider for proper
dosage form selection?
Infants and children under 5 years old: Liquid Dosage forms are
preferred than solid
When an infant is vomiting, has productive cough, non-oral
measures may be employed
Some adults, especially the elderly have difficulty
How is patient age a
swallowing, so chewable tablets can be formulated
consideration for alternate
dosage forms?
Many medications for the elderly often are formulated into
oral liquids or orally disintegrating tablets
The elderly generally take MULTIPLE medications daily, so
making the solid forms shaped, sized or colored
distinctively will allow for proper identification. Dosage
forms that allow reduced frequency are also
advantageous
What happened in August 2015 3D tablets of Levateracetam (Spritam) was approved for
that paved ways for rapid disintegration of high- dosed drugs in the mouth
advanced formulation?
A Proprietary drug that has a trademark officially registered
What is a Brand Name?