Drug Formulations

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What are the Secrets to Successful Drug
Formulations?
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Drug Formulation
Drug formulation is a process where various
chemical substances are combined with the active
drug to form a final medicinal product that is
easy and safe for human consumption. It plays a
pivotal role in the success of any pharmaceutical
development program.
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• From the early stage preclinical studies
  to the late-stage clinical trials, formulation
  chemistry is used to design a safe and effective
  product. However, formulation chemistry is often
  overlooked during the early stages of drug
  development.
• Many companies delay their planning process to
  the later stages of drug development. This can
  lead to the costly delays or failure of
  pharmaceutical development programs.

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How can the commercial drug sponsors ensure a
timely and cost-effective drug development
program?
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1) Ensure Appropriate Phase Formulation

• Whether you are developing a formulation for a
  preclinical or a clinical investigation, make
  sure that the dosage form is appropriate for the
  particular study phase. Consider the aim of each
  test and the characteristics of the active
  pharmaceutical ingredient.
• For example, preclinical studies often use
  formulations in liquids or suspensions and are
  built for the animal they are being administered
  to. Since the animals gastrointestinal tract
  conditions can affect the performance of the
  formulation, it must be taken into account during
  the formulation development process.

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2) Have an Integrated Approach to Save Time and
Money

• Effective formulations are necessary for all
  stages of drug development. Therefore,
  pharmaceutical companies cant make design
  decisions on an ad hoc basis. They must
  centralize their formulation efforts around the
  needs of the specific phase of the study.
• Moreover, formulation development process must be
  supported by a comprehensive understanding of the
  physicochemical and biochemical properties of the
  study drug.

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• In simple words, know your active pharmaceutical
  ingredient early in the study. Greater your
  efforts to know the API, easier it will be to
  predict and plan for the potential development
  issues. Further, you will spend less time,
  resources and funding to solve the subsequent
  problems.
• However, to ensure this information is used in
  the right way, there must be an open
  communication between the drug development teams.
  The pharmaceutical companies can increase the
  effectiveness and efficiency of their projects by
  following an integrated approach towards
  formulation development.

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• A formulation scientist must work closely with
  the drug discovery teams during API development
  and ensure that formulation is always an integral
  part of the development process.
• In this way, formulation decisions will always be
  based on what you want to achieve through your
  study and the program as a whole.

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The success of drug development programs depends
on robust formulation strategies at every stage
of the process. By using an early integrated
approach to formulation development,
pharmaceutical sponsors can reduce risk, maximize
efficiency and ensure that the products reach
patients in the shortest possible time.
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