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| Letter from the Editor |
| IJPC now on Facebook and Youtube |
| NAMS Announces HRT Benefits! |
| Did You Know? |
| Tip of the Week |
| Looking Back |
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| Info@CompoundingToday.com or (800) 757-4572 ext 1 |
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| To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or (405) 513-4236 |
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| The Biopharmaceutics Classification System (BCS) and Compounding: Part 12 |
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Completing our BCS topic, this week we will summarize the topic as it applies to compounding. Note: This is a slightly modified table from the September 1, 2017 Newsletter.
| Class | Permeablilty | Solubility | Compounding Considerations |
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| 1 | High | High |
- Generally provide the least problems in compounding.
- Are sufficiently soluble based on their dose and are highly permeable once in solution.
- Rate-limiting step is drug dissolution.
- 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 fastmelt systems)
- Surfactants
- Emulsion or microemulsion systems with the lipophilic drug in the internal phase
- Nanoemulsions, nanosuspensions and nanocrystals
- Solid dispersions
- Inclusion complexes using complexing agents such as cyclodextrins
- Soft-gelatin capsule with liquid-fill formulation
- Hot melt extrusion with a water-soluble carrier
- Solvates and hydrates
- Salts 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. Also, this class is problematic for slow-release development.
Permeation enhancers can 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, 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.
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Also, one should be aware that the same drug may belong to more than one class. This is especially apparent when looking up the class a drug may be in if using different resources.
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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IJPC Now on Facebook and Youtube
Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding
Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.
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Did You Know ...
�that you need to get ready? Starting Monday (and then periodically) on the CNL (Compounders' Network List), you will be able to give your "My 2 cents worth" on a specific topic. Yes, we are following up on the valuable contributions we miss from Pharmacist Mark Burger. Next week, it will be the statements of the North American Menopause Society (NAMS) on their recent announcement that hormone replacement therapy (HRT) is beneficial, but they have some derogatory remarks about compounded HRT. Below is the announcement and its source: please read and comment starting Monday, October 2, 2017. We will post their derogatory and uninformed remarks Monday morning.
If you are a subscriber to either IJPC or CompoundingToday.com you can participate in the CNL. Log into either site and choose Compounders' Network List from the menu to sign up.
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NAMS Announces HRT Benefits!
The NAMS has announced that the benefits of HRT may outweigh the risks in select women younger than age 60 or those within 10 years of menopause onset, including the risk of:
- Coronary heart disease
- Stroke
- Venous thromboembolism
- Dementia
This is according to a new position statement released in July, which is available at the following website:
http://www.menopause.org/docs/default-source/2017/nams-2017-hormone-therapy-position-statement.pdf
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Tip of the Week
Much more is covered in the NAMS report. Please take the time to read it and incorporate it into your compounding practice, and give us all your "2 cents worth" next week.
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Looking Back
This cooling shave,
Will never fail,
To stamp its user,
First Class male!
Burma Shave
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