capsule manufacturer

Capsules offer the following unique advantages as a dosage form:

Get Products to Market Faster
Help Increase Revenue
Better Suited for Cytotoxic/High Potency Drugs than Tablets
Improve Stability with Sensitive Drug Compounds
Help Address the Issue of Poorly Soluble Compounds
Ideal for Modified-release Formulations
Enable Combinations of Drugs in One Capsule
Simpler Manufacturing
Help Build Recognizable Brands
Help Improve Patient Compliance
Preferred by Patients

Get Products to Market Faster

Source: Sophartex

• Capsule formulations normally require fewer processing steps, resulting in less time needed for process optimization, documentation and equipment validation.
• Capsule formulations typically require fewer excipients than tablets, resulting in less time to select, evaluate, and validate raw materials.
• When early-phase clinical trials are conducted in capsules, there's no need for time-consuming bioequivalence testing needed to develop the commercial dose in a tablet.

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Help Increase Revenue

Source: P. Grutard (Novartis)

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Better Suited for Cytotoxic/High Potency Drugs than Tablets

• Formulating powders into capsules reduces risk of exposure as workers no longer need to handle in-process tablets prior to the coating process.
• Formulating liquids or semi-solid formulations into capsules minimizes airborne dust levels, lowering the risk of cross-contamination.
• Reduces the capital requirements for dedicated facilities, air-handling, and process equipment.

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Improve Stability with Sensitive Drug Compounds

• Encapsulation does not create high heat and pressure, thus heat-sensitive drugs can be more readily formulated in capsules.
• Capsule walls can be made opaque, thus providing protection for light-sensitive compounds.
• As capsules generally require fewer excipients, drugs that are sensitive to or highly reactive with other chemicals may be more readily formulated in capsules.

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Help Address the Issue of Poorly Soluble Compounds

Capsules allow for the development of liquid or semi-solid formulations of poorly soluble compounds, resulting in improved bioavailability of these poorly soluble drugs. Improved content uniformity is also achieved, particularly at low dosage levels.

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Ideal for Modified-release Formulations

Advantages of multi-particulate formulations include:

• Disperse freely in the GI tract, proving more uniform distribution of drug into blood stream.
• Maximize absorption.
• Minimize side effects.
• Reduce inter- and intra-patient variability.
• The concept of "One capsule per day" is a powerful consumer benefit.

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Enable Combinations of Drugs in One Capsule

• Address multiple disease symptoms - a typical situation for the elderly.
• Can also provide extended release performance.
• An opportunity for reducing loss of useful patent term because of shorter time needed to obtain a commercially viable form of the product.
• Lower development cost in comparison to NCE's.

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Simpler Manufacturing

Capsule manufacturing is simpler than tablet manufacturing for several reasons:

• Gelatin capsule manufacturing involves less manufacturing steps.
• Less analytical tests for excipients and in-process control are needed with capsule manufacturing.
• Capsule manufacturing requires less equipment.
• Installation and process validation are reduced with gelatin capsule manufacturing.

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Help Build Recognizable Brands

Capsules offer three key design elements:

• Use of two colors may enhance overall brand identity.
• Printing of logo/product name and dosing information.
• High gloss surface.

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Help Improve Patient Compliance

Color can impact proper dosing, avoiding mix-ups of elderly patients taking multiple medications. Attributes of dosage forms that aid in identification of drugs according to patients include color: 100%, name: 91%, dosage form: 84%, shape: 66%, and size: 39%. Capsules also ensure accurate dosing since they cannot be split. This helps eliminate any confusion about the proper dosage, especially for the elderly on multiple medications.

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Preferred by Patients

According to a study entitled, "Patients' Evaluation of Shape, Size, and Color of Solid Dosage Forms," 66% of patients prefer capsules, 18% prefer coated tablets, and 4% prefer uncoated tablets.

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