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| Letter from the Editor |
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| Tip of the Week |
| Looking Back |
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| The Biopharmaceutics Classification System (BCS) and Compounding: Part 8 |
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Continuing our BCS topic, this week we will look at a summary of compounding considerations for the different BCS classes of drugs.
| Class | Permeablilty | Solubility | Compounding Considerations |
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| 1 | High | High |
- Of all the classes, Class 1 drugs generally provide the least problems in compounding.
- They are sufficiently soluble based on their dose and are highly permeability once in solution.
- The rate-limiting step is drug dissolution.
- Generally, these drugs are good candidates for modified drug delivery if suitable pharmacokinetically and pharmacodynamically.
- If the situation does require a slower release rate, then hydrophilic gelling agents (cellulose derivatives) can be incorporated into the formulation.
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| 2 | High | Low | An increase in the solubility and dissolution rate will result in more efficient drug absorption. Methods used in compounding and formulating this class can include:
- Micronization
- Solvent deposition (deposition of poorly soluble drugs on inert material)
- Stabilization of high-energy states (including lyophilized fast-melt systems)
- Use of surfactants
- Forming emulsion or microemulsion systems with the lipophilic drug in the internal phase
- Forming nanoemulsions, nanosuspensions, and nanocrystals
- Forming solid dispersions
- Forming inclusion complexes using complexing agents such as cyclodextrins by kneading, steam-granulating, coprecipitating, freeze-drying, and spray-drying
- Forming polymer strip films
- Soft-gelatin capsule formulation
- Using hot-melt extrusion with a water-soluble carrier
- Use of solvates and hydrates
- Use of salt of weak acids and weak bases
- Buffering the pH of the microenvironment
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| 3 | Low | High | The issue is how to overcome the poor permeability of these compounds. An absorption enhancer may be necessary. Since absorption is permeation-rate limited, bioavailability is independent of drug release from the dosage form. Also, this class is problematic for controlled-release development.
Permeation enhancers can be formulated into the dosage form and include:
- Synthetic surfactants (SLS, Polysorbate 20 and 80, glyceryl monolaurate)
- Bile salts (sodium deoxycholate)
- Fatty acids and derivatives (oleic acid, caprylic acid)
- Chelators (sodium EDTA, citric acid)
- Inclusion complexes (cyclodextrins and derivatives)
- mucoadhesive polymers (polycarbophil, chitosan)
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| 4 | Low | Low | Formulating this class of drugs can involve both enhancing their solubility and using permeation enhancers. Methods to enhance both solubility and permeability are described above for Class 2 and Class 3 drugs. |
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Announcement
USP General Chapter <797> is currently being revised. Previously, the proposed revision was published for public comment from September 25, 2015 to January 31, 2016, and USP received more than 8,000 comments from more than 2,500 stakeholders. The newly proposed revised chapter will be republished in the Pharmacopeial Forum for another round of public comments at some time in the future. Meanwhile, the June 1, 2008 version is in effect.
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Notice
Two additional SOPs have been added this week to the over 600 SOPs already available at www.CompoundingToday.com.
- 1.096.1 Record Retention
- 14.908 Patient Disposal of Hazardous Drugs
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Did You Know ...
�that from the seat of a tractor:
- Sometimes you get, and sometimes you get got?
- The biggest troublemaker you'll probably ever have to deal with, watches you from the mirror every mornin'?
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Tip of the Week
Learn from your experiences of the past,
Evaluate the realities of the present, and
Consider the impact of your decisions for the future!
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Looking Back
The big blue tube's
Just like Louise,
You get a thrill,
From every squeeze!
Burma Shave
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