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Personalizing
dermatology care:
Selecting the right
compounding base

August 1, 2022 | 6 min read

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People are unique – and that couldn’t be truer than when considering dermatology conditions. Genetics, underlying health conditions, hormones, medications, bacteria, and contact exposure, among much more, all impact the severity of a dermatology condition and tolerance to therapy. Despite the sometimes-overwhelming amount of clinical and cosmetic products on the market, many patients and providers are left with inadequate solutions to common conditions. Unsuitable dose, suboptimal dosage form, or unwanted ingredients are just some examples of the challenges faced when compounding preparations for topical dermatologic use.

If you are a compounding pharmacist or dermatology healthcare provider, we don’t need to tell you that there is a big demand for personalized and innovative solutions to address these unmet needs. However, getting started can sometimes be daunting. Don’t worry though, we got you covered. Offering high-quality solutions to the topical treatment of dermatology conditions may be easier than you think. Read on to learn more.

Compounding for Personalized Dermatology Care


Treating dermatology conditions and their associated symptoms, such as inflammation, itchiness, redness, and irritation, typically involve topical therapies. When commercially available products don’t meet personal requirements, pharmaceutical compounding provides the flexibility to address an individual’s unique set of conditions, tolerances, and preferences, by carefully selecting cosmetic or active ingredients in the appropriate strength and dosage form (cream, lotion, gel, ointment, shampoo, or foam).

Topical bases used in compounding for dermatology conditions play a key role in the process development of a personalized formulation, such as drug-base compatibility/stability, formulation suitability for the end user, efficiency and reproducibility in processing time, and the cosmetic elegance of the final preparation.

Selecting the Right Compounding Base – Let’s Break it Down


When it comes to topical therapy, selecting the most appropriate base for the personalized formulation and patient specific needs is critical. Given the wide range of dermatology-based formulations and each individual’s unique set of specifications, a diverse line of compounding bases for skin and hair care are needed. Medisca offers a comprehensive portfolio of functional, high-quality topical compounding bases that are an excellent solution for a range of dermatology-based formulations.
Before browsing the Medisca bases, it is important to note that compounding bases are not active ingredients. They are used as a vehicle for ingredients used in pharmacy compounding, and are evaluated based on their physical properties in formulating quality compounded therapies. The examples below of such therapies are for illustration only and should not be construed as a recommendation or representation of any particular formulation or ingredient for any indications.

Creams & Lotions


Due to superior moisturizing effects (proven 24-hour moisturizer), the Medisca VersaPro™ Cream Base can help with the secondary drying effects that may be associated with conditions such as rosacea1,2 or for conditions treated with active ingredients associated with drying effects, such as benzoyl peroxide, salicylic acid, beta-hydroxy acid, and azelaic acid3,4. Additionally, VersaPro Cream Base is considered non-irritating and hypoallergenic (as determined by HRIPT) and uses non-comedogenic ingredients rendering the base suitable for acne-based formulations. VersaPro Cream Base also has a good salt tolerance, which may make the base compatible for formulas that contain active ingredient salt forms, which are prevalent in anesthetic creams5. VersaPro Cream Base is regularly tested to assess stability of common formulations. One such study currently underway is Benzocaine 20%, Lidocaine 6%, Tetracaine 4% in VersaPro Cream Base. You can browse the complete stability study databank here.

The Medisca HRT Cream Base has good vanishing properties with a pleasant texture ideal for cosmetic and dermatology applications. The base is considered non-irritating and hypoallergenic (as determined by HRIPT) and contains Vitamin E and Aloe Vera ingredients. HRT Cream Base is also compatible with hydroquinone and tretinoin, which are active ingredients used in the treatment of hyperpigmentation6, acne7, rosacea8, and skin aging9. This compatibility is supported by a stability-indicating study conducted on Hydroquinone 2-10% (Bracketed) in HRT Cream Base that documented stability for 180 days at room temperature. You can access the study here. Lastly, featuring a high pH stability range, this base may also be recommended for formulations containing certain acids, such as salicylic acid, alpha-hydroxy acid, azelaic acid, and glycolic acid.

Due to its light weight and highly vanishing effects compared with creams, the VersaPro Lotion Base may be a great solution for men and women looking for a topical application with a faster drying time. Also boasting a high pH stability range, this base may also be recommended when using certain acids. VersaPro Lotion Base is also considered non-irritating and hypoallergenic (as determined by HRIPT).

Gels


Possessing a quicker drying effect and non-comedogenic ingredients, the VersaPro Gel Base may be the preferred base for patients prone to oily skin. In addition, VersaPro Gel Base is compatible with difficult to work with active ingredients, such as hydroquinone, and is considered non-irritating and hypoallergenic (as determined by HRIPT).
CopaSil® is an anhydrous, silicone-based gel with natural copaiba oil which may make this base suitable in compounded formulations containing ingredients prescribed for scar management, including keloid scars, hypertrophic scars, and atrophic scars10-14. Furthermore, the antimicrobial effect of copaiba oil15 may render the base appropriate for certain dermatology conditions, such as acne14, dermatitis16, and psoriasis17. This base is also considered non-irritating and hypoallergenic (as determined by HRIPT) and is compatible with hydroquinone and tretinoin.

Ointments

Due to its occlusive properties, OleaBase™ Plasticized may be recommended for compounded occlusive formulations that may be determined appropriate for conditions such as psoriasis and dermatitis18,19. OleaBase Plasticized is also compatible with formulas that contain active ingredient salt forms used in anesthetic ointments5.
AlpaWash®, also occlusive and anhydrous in nature20,21, may be suitable in formulations used for wound healing. AlpaWash is also considered non-irritating and hypoallergenic (as determined by HRIPT).

Shampoos & Foams


VersaPro Shampoo is a multipurpose compounding base that is recommended for general hair and skin care. It contains Avenacare™, a cosmetic ingredient found to nourish and hydrate the scalp22.
Similarly, VersaPro Foam is intended for hair and skin care; however, it may be recommended for leave-on or extended application time treatment and as a foaming face wash. It contains Hairspa™ and Fruitbio™ which may aid in promoting optimal skin and hair health23.
Suitable for application on the scalp only, Foamil® is a very mild and non-irritating base ideal for compounding with minoxidil. This base is specifically designed to eliminate the need for otherwise common processing steps when compounding with minoxidil, notably heating and filtration. In addition, it contains AnaGain™, which has been shown to improve the appearance of hair density and may provide a vehicle for minoxidil to help prolong the life cycle of hair24. The use of Foamil with minoxidil is supported by two bracketed stability-indicating studies – Minoxidil 2-5.5% in Foamil and Minoxidil 6-15% in Foamil – that document a stability for 180 days at room temperature25.


Where to Next?


For convenient comparison, check out our Cream Base Reference Chart and our Gel Base Reference Chart.
To browse our library of stability-indicating study reports, check out our Beyond-Use Date Databank.
For continuing education opportunities in personalized dermatology for clinical and cosmetic care, check out LP3 Network's Dermatology Seminar.


References

References below are for information only and not for the purpose of representing or suggesting any ingredients or formulations for any indications.
  1. Oge', L.K., Muncie, H.L., & Phillips - Savoy, A.R. (2015). Rosacea: Diagnosis and Treatment. American family physician, 92(3), 187–196.
  2. Rivero, A. L., & Whitfeld, M. (2018). An update on the treatment of rosacea. Australian prescriber, 41(1), 20–24. https://doi.org/10.18773/austprescr.2018.004.
  3. Webster, G.F., & Rawlings, A.V. (2007). Acne and its therapy (1st ed.). CRC Press. https://doi.org/10.3109/9781420018417.
  4. Kessler E., et al. (2008). Comparison of alpha- and beta-hydroxy acid chemical peels in the treatment of mild to moderately severe facial acne vulgaris. Dermatol Surg. 34(1):45-50; discussion 51. doi: 10.1111/j.1524-4725.2007.34007.x.
  5. Kumar, M., Chawla, R., & Goyal, M. (2015). Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 31, 450-456.
  6. Rigopoulos, D., & Katoulis, A. (2018). Hyperpigmentation. Boca Raton, FL: CRC Press.
  7. Bayramgürler, D., Kartal, S.P., & Altunel, C.T. (2017). The Use of Topical Retinoids in Acne.
  8. Freeman, S. A., Moon, S. D., & Spencer, J. M. (2012). Clindamycin phosphate 1.2% and tretinoin 0.025% gel for rosacea: summary of a placebo-controlled, double-blind trial. Journal of drugs in dermatology: JDD, 11(12), 1410–1414.
  9. Mukherjee, S., Date, A., Patravale, V., Korting, H. C., Roeder, A., & Weindl, G. (2006). Retinoids in the treatment of skin aging: an overview of clinical efficacy and safety. Clinical interventions in aging, 1(4), 327–348.
  10. Waibel, J., et al. (2021). Prospective, randomized, double-blind, placebo-controlled study on efficacy of copaiba oil in silicone-based gel to reduce scar formation. Dermatology and Therapy
  11. Bermann, B., Maderal, A., & Raphael, B. (2016). Keloids and hypertrophic scars: Pathophysiology classification, and treatment. American Society for Dermatologic Durgery, Inc.
  12. Momeni, M., et al., (2009). Effects of silicone gel on burn scars. Burns, 35, 70-74.
  13. Onselen, J.V. (2018). Scars: Impact and management, with focus on topical silicone-based treatments. British Journal of Nursing, 27.
  14. Da Silva, A.G., et al. (2012) Application of the essential oil from copaiba (copaifera langsdorffii Desf.) for acne vulgaris: A double-blind, placebo controlled clinical trial. Alternative Medicine Review, 17, 68-75.
  15. Guimaraes, A.L.A., et al., (2016). Antimicrobial activity of copaiba (copaifera officinalis) and Pracaxi (Pentaclethra mmacrobola) oils against straphylococcus aureus: Importance in compounding for wound care. International Journal of Pharmaceutical Compounding, 20.
  16. Viriato, E.P., et al. (2009). Study of high dilutions of copaiba oil on inflammatory process. Int J High Dilution Res, 8, 9-14.
  17. Herman, A. & Herman A. (2016). Topically used herbal products for the treatment of psoriasis – Mechanism of action, drug delivery, clinical studies. Planta Med, 82, 1447-1455.
  18. Torsekar, R. & Gautam, M.M. (2017). Topical therapies in psoriasis. Indian Dermatology Online Journal, 8, 325-245.
  19. Gupta, M.., et al. (2014). Zinc therapy in dermatology: A review. Dermatology Research & Practice.
  20. Nani, M., et al. (2018). Evaluation and comparison of wound healing properties of an ointment (AlpaWash) containing micronized propolis and peucedanum ostruthium leaf extract in skin ulcer in rats. International Journal of Pharmaceutical Compounding, 22.
  21. Lupatini Nogueira, R.J., et al. (2016). Evaluation of the antibacterial activity of Green Propolis extract and Meadowsweet extract against straphylococcus aureus basteria: Importance in wound care compounding preparations. International Journal of Pharmaceutical Compounding, 20.
  22. Biovelop Technical Brochure. (2015). Avenacare: Active oat beta glucan ingredient for skin, hair and body.
  23. Sederma Technical Brochure. (2014). Study Report – FruitBio: Evaluation of the smoothing effect.
  24. Mibelle Technical Brochure. (2013). Study Report - Anagain: Anti-Hair Loss Effect and Hair Growth Reactivation.
  25. Lupatini, R., et al. (2021). Stability evaluation of minoxidil in FOAMIL foam base with bracketing study design. International Journal of Pharmaceutical Compounding, 25.




Amoxicillin Shortage
Non-Sterile Compounding:
A Guide to Primary
Engineering Controls

August 29, 2023 | 5 min read

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Revised USP <795> and Primary Engineering Controls

In November 2022, the long-awaited update to the United States Pharmacopoeia (USP) General Chapter <795> on Non-Sterile Compounding was released. The revisions have many non-sterile compounding pharmacies across the United States buzzing with questions about what necessary changes must be implemented, sparking renewed interest in primary engineering controls (PECs).

PECs are devices employed directly at the point of use1 that control airborne contamination from the working environment2. The USP <795> Chapter calls out specific requirements for PECs used in non-hazardous and hazardous compounding in order to ensure compounder safety and minimize environmental exposure. PECs can be broken down into three main categories2:
  • Containment ventilated enclosure (CVE, i.e., powder hoods).
  • Biological safety cabinet (BSC, i.e., laminar flow hoods).
  • Compounding aseptic containment isolator (CACI).

During the compounding of hazardous drugs, PECs are designed to ensure the containment of hazardous material, hence the name containment PECs (C-PECs)2. But the challenge remains: which PECs to use and how to be compliant with USP Chapters <795> and <800>?.
The regulations surrounding PECs used in non-sterile compounding leave room for interpretation, illumining the importance of implementing best practices. Being compliant is one thing. Applying best practices is another. It is the collective responsibility of all compounders to uphold the integrity of the compounding practice. As you adopt these standards and apply best practices, you'll not only stand out from the competition but, more importantly, position yourself as a preferred partner for physicians seeking collaboration and patients needing your services. After all, physicians look for trusted partners who prioritize quality and patient safety. Patients, in turn, seek reliable pharmacies they can entrust with their health.

Non-Hazardous Compounding

Although the USP <795> does not lay forth specifics on hood selection for non-sterile non-hazardous compounding, it does require that compounding pharmacies perform an evaluation to determine what compounding activities result in powder generation. To better understand where such activities must be conducted in a hood, see the excerpt from the new USP <795> chapter below3:

"Weighing, measuring, or otherwise manipulating components that could generate airborne chemical particles (e.g., active pharmaceutical ingredients [APIs], added substances, and conventionally manufactured products) must be evaluated to determine if these activities must be performed in a closed-system processing device to reduce the potential exposure to personnel or contamination of the facility or CNSPs. Examples of closed-system processing devices include containment ventilated enclosures (CVEs), biological safety cabinets (BSCs), and single-use containment glove bags. The process evaluation must be carried out in accordance with the facility’s SOPs, and the assessment must be documented.”

Interestingly, the USP stops short of clearly defining how to assess powder generation, making it vague. However, if you've ever weighed out stevia and tasted its sweet flavor in the air or seen wisps of ketoprofen dust floating around while compounding, you know for certain that powders can indeed become airborne. By these lines, although the chapter takes a roundabout way of outlining when hoods are required, it is hard to imagine an instance where they should not be required. There is also value in consistency. All powders can generate airborne particles, so rather than evaluate each product (through an undefined, objective method), performing non-sterile, non-hazardous weighing, measuring, and manipulative activities in that same closed-system space would be more straightforward.
It’s important that we do not underscore the importance of taking the precautions to protect the compounder, safeguard the integrity of the preparation, and reduce cross-contamination exposure. Compounding pharmacist and owner with over 25 years of experience, Mark Filosi, said it well:

“We used to think coal dust and sawdust was inconsequential. I don’t want to learn 20 years from now that I should have been using a hood. Also, regardless of the hazard level, a hood does help prevent cross-contamination from one prep to the next. It cuts down on the residue of the previous preparation.”

So, what’s the take-home message? Simple. A PEC should be required for all non-sterile compounding activities. When evaluating which hood, always look for certifications from reputable organizations to ensure that your chosen equipment aligns with USP standards. For instance, the XPert Filtered Balance System Powder Containment Hood by Labconco is a CVE that checks off all of the boxes. It uses a built-in blower and HEPA filter to contain powders during weighing to help ensure the safety of the compounder.


Hazardous Compounding

For hazardous drug compounding, the necessity of a hood is apparent. According to the USP General Chapter <800> on Hazardous Drug Compounding, all activities must be performed in a C-PEC offering personnel and environmental protection through external ventilation or HEPA filtration3. However, when choosing the right hood for your specific compounding activities and compounding space, several factors should be taken into consideration:

  • State Law Requirements: Before deciding on a hood, you must be aware of the specific requirements set forth by your state's laws. For instance, some states may stipulate the need for exterior hood ventilation, while others might leave it to the compounder's discretion. There might also be requirements for features like a waste chute.
  • Anticipated Volume: Reflect on the volume your lab is currently compounding and anticipating to compound to help determine whether you'll need multiple C-PECs for your HD compounding room. Remember, if you plan on having multiple C-PECs inside a containment secondary engineering control (C-SEC; i.e., the room in which the C-PEC is placed), you must respect hood placement and air change per hour (ACPH) requirements. For instance, the USP <800> Chapter mandates that all C-PECs be placed in a negative pressure room with a minimum of 12 ACPH4.
  • Type of Equipment: Keep in mind the equipment you plan to use within the hood, as it will directly affect the available workspace for compounders. It also influences the hood's height, especially if some equipment demands extra clearance.
  • Presence of Fumes: If your compounding activities involve fumes, it is essential to invest in a hood designed with filters to handle them safely and effectively.

With these points in mind, Class I BSCs are designed for personnel and environmental protection by pulling air from the room through the front, away from the operator. They may be externally vented with a single HEPA filter or have two redundant HEPA filters that exhaust back into the room, although USP indicates that the former is preferred3. The RXPert Single Filtered Balance System is an example of a high-quality C-PEC used for hazardous compounding. This Class I BSC is designed to meet the USP <800> standards and features a factory-installed canopy and HEPA filtration.

A Class II BSC used for sterile compounding may be used for occasional non-sterile hazardous compounding but must be decontaminated, cleaned, and disinfected before resuming sterile activities3. A Class II BSC is defined as a ventilated cabinet intended for personnel, product and environmental protection, designed with an open front and inward airflow (personnel protection), downward HEPA-filtered laminar airflow (product protection), and HEPA-filtered exhaust air (environmental protection).


The Medisca Advantage: Service, Selection and Peace of Mind

There are many factors to consider when selecting the proper engineering controls for your compounding pharmacy. Yes, you need to be compliant with USP <795> and USP <800>, but you also need to make sure that the devices you choose fit the needs and future direction of your pharmacy. It all boils down to a few questions:
  1. Are you compounding, and do you plan to continue compounding non-sterile preparations?
  2. What drugs are you handling (i.e., hazardous or non-hazardous)?
  3. What limitations exist regarding costs (i.e., budget) and facility (i.e., compounding space, lease restrictions, building permits, accessibility, outside ventilation, etc.)?

With a team of experts specializing in hood selection for pharmaceutical compounding needs and a portfolio of 40 hoods for non-sterile compounding, Medisca supports compounders in addressing these questions and finding the best-fitted solutions for their specific pharmacy and/or facility needs. Medisca equipment specialists – led by a team of highly trained individuals with years of in-field experience – are here to walk you through all the steps of implementing a USP-compliant hood in your compounding pharmacy.

Ready to embrace best practices and elevate your PECs? Contact an account representative to connect you with an Equipment Specialist today.

Looking for more information on the revised USP General Chapters <795> and <800>? Visit here.

References:

  1. Wagner, JT. Considerations for choosing primary engineering control for compounding sterile products. IJPC 2005; 9(4): 284-290.
  2. Chapter 12: Types of Engineering Controls. The Chapter <800> Answer Book.
  3. <795> Pharmaceutical Compounding – Nonsterile Preparations. United States Pharmacopoeia WebSite. Retrieved from: https://www.uspnf.com/sites/default/files/usp_pdf/EN/ USPNF/revisions/gc-795-postponement-rb-notice-20191122.pdf
  4. <800> Hazardous Drugs – Handling in Healthcare Settings. United States Pharmacopoeia WebSite. Retrieved from: https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare

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