We will be out, but our eCommerce is in!
Dec 24 | Dec 27 | Dec 31 | Jan 3
Please note that no shipments will be going out on Dec 24, Dec 27, Dec 31, and Jan 3, due to public holidays and facility closures. We encourage all customers to place their orders well in advance during the busy holiday season. Delays can be expected on ground orders in some areas.
Dear valued partner,
Every year we take some time to celebrate our employees and our progress as an organization.
This year, Medisca Day will take place on the afternoon (EDT) of June 9, 2023, which means that all services and warehouse operations will be on hold for a few hours. Please contact us before 11:30 am EDT otherwise we will be pleased to serve you on Monday, June 12.
We thank you for your partnership.
The Medisca Team
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"Adding NovaFilm Oral Transmucosal Films to our product portfolio continues our focus in delivering a convenient and rapid onset dosage form that we know our patients will prefer over traditional forms. Getting to offer a product that embodies our passion for improving male healthcare outcomes is truly a pleasure. We thank Medisca for their ingenuity and perseverance within the compounding world."
- Sam Knight (Director of Pharmacy Operations)
Testing the water activity of NovaFilm OTFs after either oven dried for 1 hour at 50 C or air-dried under a ventilated enclosure for 16 hours resulted in an average water activity of 0.342 and 0.287 respectively. The addition of powdered ingredients, such as APIs or flavors should not increase the water activity. This was also shown during testing where blank and compounded NovaFilm OTFs all came back with a water activity under 0.6.
According to USP <795> Pharmaceutical Compounding – Non-Sterile Preparations (to be official November 1, 2023), non-aqueous dosage forms that are defined as having a water activity less than 0.6, may receive a beyond-use date (BUD) limit of 180 days. Testing revealed that NovaFilm OTFs have a water activity that is less than 0.6 when dried in the oven or air dried, and may therefore receive a BUD of 180 days according to USP <795> (2022). According to current Australian Pharmaceutical Formulary (APF) Guidelines, NovaFilm OTFs would have a BUD of 28 days as of current.
The dimension of each film, using our NovaFilm OTF Blister Mold is 3 cm x 3 cm.
Generally speaking, the maximum API concentration per NovaFilm OTF is 50 mg. Yes, NovaFilm OTFs can be compounded with multiple APIs, as long as the combined maximum concentration does not exceed 50 mg.
It is not recommended to cut the NovaFilm OTFs in order to split into multiple doses.
The quality control weight testing can be performed similarly to capsules. Once dried, the blister molds can be separated and then weighed individually. The blister molds are designed to have the same dimensions once separated individually; therefore, you can calculate the average weight of a single mold cavity and subtract this from the actual weight. Then you would be able to use this weight to determine if the compounded NovaFilm OTFs fall within 90-110% of the theoretical weight according to USP <1163>.
Compared to troches, both OTFs and RDTs have a significantly shorter disintegration times. NovaFilm OTFs also have the added feature of being mucoadhesive. This mucoadhesive property is expected to prolong the film contact time with the mucosa compared to an RDT, and in turn has the potential of reducing the amount of API being swallowed rather than absorbed mucosally. Moreover, because of its mucoadhesive property, NovaFilm OTFs can also be used for administration to several different mucosal sites in the oral cavity, such as palatal, buccal, and sublingual. In addition, if you are looking to compound with heat sensitive APIs, NovaFilm OTFs are ideal as they can be air dried without any need for heat. Lastly, the maximum API concentration can vary significantly between the dosage forms based on the molds used. NovaFilm OTFs are recommended for a maximum dose of 50 mg per film, whereas RDTs can be as high as 200 mg and troches as high as 300 mg.
If looking for mucoadherance in the esophagus, OTFs would not be the recommended dosage form. Instead, it is recommended to utilize NovaFilm Gel Base in combination with an oral vehicle or Purified Water, USP to compound a mucoadhesive oral liquid. See the follow formula as an example: F 008 262 Nystatin 100 000 IU per mL Oral Mucoadhesive Liquid
An oven is not required to dry NovaFilm OTFs; however, it is the recommended and preferred method when possible. For a faster and more controlled compounding process, a convection oven can be used at a temperature that does not exceed 50 degrees Celsius. The drying time will vary based on the formula, however the typical range is from 50-90 minutes at 50 degrees Celsius. Alternatively, for heat sensitive APIs, the OTFs can also be dried at room temperature in a containment ventilated enclosure overnight for about 16 hours.
Yes, NovaFilm OTFs are a great dosage form option for veterinary patients. That being said, NovaFilm Gel Base contains Sodium Benzoate as a preservative, therefore, we recommend a veterinarian assess its appropriateness for felines (cats), especially when using for extended periods of time. The flavor choice can be done according to the pet's preference; however, it is recommended that only powder flavors are used.
NovaFilm OTFs are solid dosage forms and do not require ice packs when shipping. If compounding with an API that requires storage under refrigeration, then the OTFs should be shipped accordingly.
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Please note that MEDISCA will no longer accept any returns and will not issue any credits for active pharmaceutical ingredients (APIs).
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