Drug Forms. Development of Drug.

1
Drug Forms. Development of Drug.
2

• Original drug (Brand name drug) a drug on the
  market that contains medication not known before.
  It is protected several years by patent, since a
  company spent money on research, marketing and
  promotion.
• Generic drug is a drug without patent
  protection. Needs to be bioequivalent to the
  brand name drug with respect to pharmacokinetic
  and pharmacodynamic properties.

3
Ways of administration

• Way of administration is the way through which
  drug reaches organism. Way of adinistration
  depends on drug form, physical and chemical
  properties of the drug and psysical and mental
  state of the patient. Ways of administration are
  divided to local (topic) and systemic. Systemic
  administration can be enteral or parenteral.
• local
• Administration enteral
• systemic
• parenteral

4

• Druf forms can be divided according to
  consistency to liquid, solid, semisolid and
  gaseous.
• Drug forms can also be set for internal or
  external use.

5
Solid drug forms

• tablets
• coated tablets
• tablet or capsule with retarded drug release
• capsules
• powders
• granulationes
• species

6
Semisolid drug forms

• ointment
• cream
• paste
• suppository
• patch

7
Liquid drug forms

• enteral
• peroral administration
• solution
• syrup
• drops (eye drops cant be opened more than one
  month)
• rectal administration
• clysma
• parenteral
• injections
• infusion
• transfusions
• local
• solutions
• emulsions
• suspensions
• foams

8
Gaseous drug forms

• Aerodispersions

9
Drug development

• synthesis of novel chemical compounds
• preclinical testing (cell cultures, isolated
  cells, isolated organs ? animals)
• clinical trials phase I (healthy people)
• clinical trials phase II (selected patients)
• clinical trials phase III (large group of
  patients, the drug is compared to conventional
  treatments, e.g. double-blind study)
• registration of the drug (a national regulatory
  body)
• clinical trials phase IV (surveillance after
  licence)