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Tablets & Capsules SDD
imageIn this issue of T&C Solid Dose Digest:
 
 
 
 
 
 
 
recro

kikusui
 
In Tablets & Capsules magazine
 
Liquid capsule filling for poorly soluble drugs
 
Gabriela Dujovny and Ryan Taro, Qualicaps
 
Hard capsules have traditionally been used to deliver powder or granule formulations, but in recent years, formulators have increasingly used them to deliver oily liquids and semi-solid formulations. These lipid-based formulations (LBFs) typically improve the solubility, dissolution, and absorption of poorly soluble APIs. For example, systems comprising mixtures of surfactant and oil, or self-emulsifying drug delivery systems (SEDDS), result in a dispersion of fine emulsion droplets in situ [1].
 
Softgel capsules have been widely used for LBFs, but liquid-filled hard capsules (LFHCs) provide an attractive alternative. LFHCs are typically composed of a shell of gelatin, a blend of gelatin and polyethylene glycol (PEG), or hydroxypropyl methylcellulose (HPMC). Unlike softgels, hard capsules don't contain plasticizers—except for PEG-gelatin or other special cases—reducing the potential for API migration from the fill to the capsule shell. Also, assuming proper engineering controls are in place to protect the operator, hard capsules offer the ability to fill at higher temperatures than softgels, up to 50°C for gelatin and 70°C for HPMC.
 
To learn more about this topic, you can read the article "Back Page: Liquid capsule filling for poorly soluble drugs." You can also find articles under "Capsules and capsule filling" and "Formulation" in Tablets & Capsules' Article Archive.
 
 
camfilapc

gelita
 
Ask an Expert
 
Modifying a previously approved sustained-release formulation
 
Q: How can we avoid additional clinical studies when modifying a previously approved sustained-release formulation?
 
 
Circumstances sometimes demand modifications to formulations that regulators have already approved. For example, a scenario might arise in which a new owner acquires a key supplier and promptly announces that the supplier is discontinuing the release-controlling polymer in your lucrative, FDA-approved product. The supplier offers a similar alternative, but your formulation team's initial qualification of the replacement polymer indicates that you'll need to increase the coating material to achieve the original, approved, modified-release dissolution profile. How should you proceed?
 
 
 
wilson

jost
 
More Questions and Answers
 
Designing easy-to-swallow tablets
 
Q: How do I design a tablet that is easy to swallow?
 
A: Natoli technical team, Natoli Engineering, says:
 
The tablet is the most common solid dosage form. Consumers find tablets appealing for their various sizes, shapes, colors, designs, and coatings but also often find them hard to swallow. Appearance and user experience can quickly determine whether a consumer will purchase a tablet product again or continue to take the product as prescribed, so it's important for tablet manufacturers to consider the consumer when designing a tablet and tooling.
 
 
 
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nilfisk
 
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May 20, 2019
 
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T&C Solid Dosage Sourcebook
 
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Send your feedback or questions to Peggy Wright at pwright@cscpub.com.
Peggy Wright
T&C Solid Dose Digest
Editor
pwright@cscpub.com
 
Kyle Myers
T&C Solid Dose Digest
Circulation
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Kurt Beckman
T&C Solid Dose Digest
Designer
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Nate Todd
Tablets & Capsules
Editor
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