(PM3B) Biomacromolecules + Biologics Flashcards

1
Q

What is a biologic?

A

A biomacromolecule used as a drug

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2
Q

How does a biologic differ from a small molecule? What can be said for their route of delivery?

A

(1) >1000g/M - instead of <500g/M

(2) Organic (hydrophilic polypeptide) instead of a carbon chain

(3) High complexity, a single protein, moderate heterogeneity (slight mixture)

(4) Both delivered at site of action

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3
Q

Give 3 examples of a biologic.

A

(1) Flu vaccine
(2) Monoclonal antibodies
(3) Insulin

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4
Q

What is the most common route of administration for biologics?

A

Injection - parenterally

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5
Q

What 4 categories can biologics be grouped into?

A

(1) Gene therapy - nucleic acids

(2) Polypeptides - e.g. proteins and peptides

(3) Polypeptides - e.g. monoclonal antibodies

(4) Vaccines

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6
Q

What are some general pharmaceutics challenges for biologics/ biomacromolecules?

A

(1) Increased complexity

(2) Instable - inherent from biological origin

(3) Limited availability

(4) Immunogenicity - drug hypersensitivity to immune response - can lead to loss of efficacy

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7
Q

Why types of complexity is there for biologics? MFC

A

(1) Molecular complexity
(2) Functional complexity - more expensive to produce
(3) Composition complexity - manufacturing/ distribution issues

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8
Q

How can biologics/ biomacromolecules become unstable?

A

Formulations can go mouldy/ grow bacteria

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9
Q

Why are proteins unstable?

A

(1) 3-4 layers of structure

(2) Polypeptide chain is susceptible to reactions with water/ oxygen

(3) Many changes are irreversible

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10
Q

What is a common problem with biologic/ biomacromolecule drugs?

A

Often oral unsuitable - digested as food

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11
Q

How is insulin most often administered?

A

Subcutaneously

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12
Q

What is the general purpose of a polypeptide biologic?

A

To act as an endogenous protein

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13
Q

What are 2 methods of pharmaceutical protein manufacture?

A

(1) Biotechnology
- Produced in microbial/ animal cell cultures
- Isolated via chromatographic + filtration steps

(2) Isolate from blood
- From blood/ tissue of animal

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14
Q

What is a major downside of isolating biologics from animals’ blood/ tissue?

A

Transfer of viral infection

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15
Q

What are 3 different types of insulin?

A

(1) Purified animal insulin

(2) Recombinant human insulin

(3) Variants of human insulin - changes speed of onset/ duration of action

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16
Q

What is a hexamer (6-mer)?

A

6 insulin molecules around a zinc ion

17
Q

What are 3 possible treatment regimes for Type 1 Diabetes?

A

(1) 1/2/3 insulin injections per day
- Short or rapid-acting

(2) Multiple daily injections (before meals)

(3) Continuous SC insulin infusion
- Programmable pump

18
Q

What would be the advantages/ disadvantages of needle-free injectors?

A

(1) Fewer needles

(2) Complex to use + can cause bruising

19
Q

Why can insulin not be administered transdermally?

A

Poor bioavailability - due to high Mr and hydrophilicity