Exam 3 - Dosage Forms for Biologics Flashcards
(23 cards)
Define “biologics”
medications derived from or produced by living organisms (big molecules that are made in/produced in cells)
Give examples of biologics
- Recombinant proteins
- Peptides
- Blood factors
- Vaccines
- Oligonucleotides
- mRNA
- Cell-based therapies (new kind of living drugs)
What percent of marketed drugs are “small molecule” drugs?
90%
List types of “large molecule drugs”, or biologics
- Recombinant proteins, peptides
- mRNA, oligonucleotides
- Cell and gene therapies
Describe “Recombinant proteins, peptides”
- a type of biologic drug
- cell culture
- in 2017, 7/10 top drug sales were proteins
Describe “mRNA, oligonucleotides”
- a type of biologic drug
- cell-free (IVT)
- ex. mRNA COVID vaccine
Describe “Cell and gene therapies”
- Cell culture
- The first live drug (Kymriah) was approved in 2017
Describe the distribution of drug TYPES among the top 20 drug sales in 2023
13 biologics (2/3 of total)
2 peptides
5 small molecules
Give examples of monoclonal antibodies (mAbs)
Humira®, Herceptin®, Avastin®
Describe the structure of mAbs
- Glycoproteins, high beta-sheet content (no helical structure)
- Quaternary structure: two light chains (L) and two heavy chains (H) linked by SS bond
- Antigen binding occurs through the variable domain (V), at the complementarity determining region (CDR)
- The constant (C) domain helps determine biodistribution, plasma half-life
Describe antibody-drug conjugates (ADCs)
- A growing class of mAb-based drugs in development
- Combine target specificity of mAb with efficacy of small molecule drug
- Can use mAb fragments rather than whole mAb
Describe mRNA biologics
- a linear polymer of nucleotides
each nucleotide subunit consists of:
- nucleobase (C, G, A, U)
- ribose
- phosphodiester bond (the problem)
this is the site of chemical instability → due to being charged
Give an example of an oligonucleotide biologic (small mRNA)
spinraza (nusinersen) injection
modified antisense oligonucleotide used to treat spinal muscular atrophy
List the different types of vaccines
- inactivated
- attenuated
- toxoid
- conjugate
- subunit
T/F: vaccines can be larger than biologics
TRUE, can be orders of magnitude larger
Describe peptide drugs
- Linear chains of amino acids (made of 50 amino acids or less)
- Shorter than proteins
- Some secondary structure; no higher order structure (not many folding structures/beta sheets)
- Some with chemical modifications
Define “peptide”
short chain of amino acids
Define “peptide analog”
chemically modified peptide where one or more amino acids are changed
Define “peptidomimetic”
mimics a peptide but is not a peptide
Give examples of early peptide drugs
insulin & glucagon
List examples of peptidomimetic drugs
Telaprevir (Incevik®, Vertex)
Hep C
List the common dosage forms for biologics
- Solutions for injection
- Pre-filled syringe (PFS), pen, or autoinjector
- Lyophilized powder for reconstitution
How are biologics dosed?
PARENTERAL
