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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...
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Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
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3D printed dosage forms, where are we headed?

Ishwor Poudel1, Nur Mita1,2, R Jayachandra Babu1

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3D printing (3DP) is revolutionizing drug product development, offering personalized pharmaceutical solutions. While regulatory guidelines are still evolving, 3DP holds significant promise for the future of medicine.

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Area of Science:

  • Pharmaceutical Sciences
  • Biotechnology
  • Materials Science

Background:

  • 3D printing (3DP) has emerged as a transformative technology in healthcare and manufacturing over the past decade.
  • The pharmaceutical industry has seen increasing interest in 3DP for drug product development, highlighted by the USFDA approval of 3D printed tablets.

Purpose of the Study:

  • To review current 3D printing technologies for drug product fabrication.
  • To discuss emerging technologies, including Artificial Intelligence (AI), in pharmaceutical 3DP.
  • To address limitations and regulatory challenges in industrial 3DP drug manufacturing.

Main Methods:

  • Review of major 3D printing technologies used in drug product fabrication.
  • Analysis of regulatory updates and current limitations in the field.
  • Exploration of future perspectives and potential of 3DP in pharmaceuticals.

Main Results:

  • 3DP enables rapid prototyping and personalized pharmaceutical dispensing.
  • Significant advantages exist for patient-specific drug formulations.
  • The field is poised for exponential growth, driven by personalization trends.

Conclusions:

  • 3D printing is a paradigm-shifting asset for pharmaceutical professionals.
  • Addressing regulatory hurdles is crucial for large-scale industrial adoption.
  • The future of 3DP in pharmaceuticals points towards increased personalization and innovation.