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Oral Solid Dosage Formulation Development

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Oral solid dosage forms (ODS) are the easiest formulations to manufacture and distribute which allows for a low cost of commercial goods manufacturing. Most molecules tend to be more stable in solid form as compared to drugs which are dissolved or suspended in liquids. From a patient perspective, oral solid dosage forms provide convenience in terms of medication storage, ease of administration, and for taking medicine on the go. It’s no surprise that over 60% of the medicine being sold in the US come in some form of an oral dose.

Oral solid dosage form development and manufacturing technology has evolved greatly throughout years of research and there are drug delivery systems available for almost every use imaginable. The most typical oral dose options come in the form of tablets and capsules.

Over 60% of the medicine being sold in the US comes in some form of an oral dose.

Pharmaceutical tablets have the advantage of relatively easy manufacturing, with high-speed presses capable of manufacturing 1M+ tablets in a typical eight-hour shift. This allows for a minimal cost of goods in commercial manufacturing. Tablet manufacturing typically involves direct blending and compression or may sometimes require granulation to ensure proper powder flow, mixing, and compressibility. Many varieties of drug delivery systems utilize this tablet dosage form.

Capsule dosage forms can provide a better solution when simplicity in drug development is a priority or if the drug delivery system needs to meet complex drug release profiles, such as multiphasic drug release profiles.

Immediate-release (IR)
Simple immediate-release tablets are designed to rapidly release the drug once swallowed.
Orally disintegrating tablets (ODT) and chewable tablets are designed to dissolve in the mouth prior to swallowing, which can be convenient for larger doses or for patients who have difficulty swallowing tablets.
Enteric-coated tablets are designed to withhold releasing its active ingredient in the stomach. These dosage forms are typically needed for medications which are not stable in the stomach’s acidic pH or medications that are designed to specifically targeted different parts of the gastrointestinal (GI) tract.
Controlled-release tablets, sustained-release tablets, and/or extended-release tablets are dosage forms which release their active ingredient at a specific rate over time as designed by the formulator to achieve a specific therapeutic effector or enhance patient convenience.
Bilayer tablets, or multi-layer tablets, are often used when two API or drug molecules need to be kept separate within the same dosage form due to incompatibility or when a combination of immediate-release and extended-release functions is necessary.Bilayer tablets, or multi-layer tablets, are often used when two API or drug molecules need to be kept separate within the same dosage form due to incompatibility or when a combination of immediate-release and extended-release functions is necessary.
Powders in capsule formulations are some of the simplest formulations to develop and are widely used to manufacture early-phase clinical trial material or investigational material for animal studies.
Capsules filled with coated multiarticulate beads or minitablets are more complex to develop and commercially manufacture but can provide greater flexibility in terms of drug targeting and drug release in the body. These drug delivery systems are often selected based on a specific clinical or commercial need.
Simple immediate-release tablets are designed to rapidly release the drug once swallowed.

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Powders in capsule formulations
Powders in capsule formulations are some of the simplest formulations to develop and are widely used to manufacture early-phase clinical trial material or investigational material for animal studies.
Capsules filled with coated multiarticulate beads or minitablets are more complex to develop and commercially manufacture but can provide greater flexibility in terms of drug targeting and drug release in the body. These drug delivery systems are often selected based on a specific clinical or commercial need.

Pharmaceutical tablets have the advantage of relatively easy manufacturing, with high-speed presses capable of manufacturing 1M+ tablets in a typical eight-hour shift. This allows for a minimal cost of goods in commercial manufacturing. Tablet manufacturing typically involves direct blending and compression or may sometimes require granulation to ensure proper powder flow, mixing, and compressibility. Many varieties of drug delivery systems utilize this tablet dosage form.

  • Simple immediate-release tablets are designed to rapidly release the drug once swallowed.
  • Orally disintegrating tablets (ODT) and chewable tablets are designed to dissolve in the mouth prior to swallowing, which can be convenient for larger doses or for patients who have difficulty swallowing tablets.
  • Enteric-coated tablets are designed to withhold releasing its active ingredient in the stomach. These dosage forms are typically needed for medications which are not stable in the stomach’s acidic pH or medications that are designed to specifically targeted different parts of the gastrointestinal (GI) tract.
  • Controlled-release tablets, sustained-release tablets, and/or extended-release tablets are dosage forms which release their active ingredient at a specific rate over time as designed by the formulator to achieve a specific therapeutic effector or enhance patient convenience.
  • Bilayer tablets, or multi-layer tablets, are often used when two API or drug molecules need to be kept separate within the same dosage form due to incompatibility or when a combination of immediate-release and extended-release functions is necessary.

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