What are Analytical Laboratory Services for Drug Testing and Analysis

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What are Analytical Laboratory Services for
DrugTesting and Analysis
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• Before a drug is released, pharmaceutical testing
  of the product is the key to quality control and
  drug development. Typically, drug testing
  measures how active pharmaceutical ingredient
  (API) from the product matrix is released when it
  is in a controlled laboratory environment. In the
  testing, the dosage of the drug is subjected to a
  set of conditions which leads to drug release.
  During this time, it is predicted how in vitro
  conditions will turn out in vivo conditions. The
  in vivo condition here means humans.
• Talking in terms of quality control, drug testing
  is utilized to assess whether a batch complies
  with pre-set criteria. This also includes the
  long-term stability of the active pharmaceutical
  ingredient.

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• Understanding DissolutionTo know how dissolution
  is used to find out the changes in the
  performance of drugs, understanding the process
  is important.
• For most of the oral drugs that we consume, the
  absorption of API is necessary for systemic
  circulation as it helps in taking the API to the
  site of action. This whole process is divided
  into two parts, dissolution and permeability or
  absorption. During the dissolution phase, the
  solid form of the drug is extracted in solution
  form in the GI tract. Then, during absorption,
  the drug substance is taken to the systemic
  circulation.

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• Drug Testing by Analytical Testing Services
• To assess the manufacturing stability and quality
  of drug product, in vitro drug dissolution
  studies are carried out by the analytical
  services laboratory. Some of these methods used
  for drug testing are explained below
• Oral Dosage Testing This In vitro testing
  assesses how an oral drug product goes into
  solution form per unit time when it issubjected
  to standardized conditions. The major goal of
  this type of dissolution is to check the
  bioavailability of the drug. Apart from this, the
  oral dosage dissolution also tests how safe the
  drug product is and what is the influence of
  manufacturing process variance on the drug.

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• Transdermal and Topical In Vitro Release Testing
  
• A vertical diffusion cell is utilized to
  understand the API release in case of transdermal
  and topical products. The product is placed such
  that it is in contact with the membrane, which,
  in turn, is in contact with the receiving medium.
  The receiving medium is basically a time
  function. The membrane is made of animal skin,
  cadaver, synthetic polymer, and tissue
  constructs. This technique is useful for topical
  formulations that are externally applied along
  with products used for rectal, vaginal, and nasal
  routes.
• Elution Testing
• Elution testing is carried out for a drug-device
  combination, in which,

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• how the drug leaves the device is evaluated. This
  is achieved by placing the device containing a
  drug into a suitable medium. In the elution test,
  the medium choice, exchange frequency, and test
  volumes depend on the device's nature.
• It is necessary for dissolution or drug testing
  to choose the right testing condition in
  accordance with the drug medium for a desirable
  outcome. The correct execution of in vitro is
  essential for simulating the nearly similar
  impact of the drug in the in vivo conditions.

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• Thanks