Kit includes:
General Sample Formulas
| Formula Number |
Formula Title |
| F 009 667 |
Sildenafil 22mg Oral Transmucosal Films (Solid Suspension, 30 Films) |
| F 009 670 |
Progesterone 40mg Oral Transmucosal Films (Solid Suspension, 30 Films) |
| F 009 673 |
Naltrexone Hydrochloride 4.5mg Oral Transmucosal Films (Solid Suspension, 30 Films) |
| F 009 711 |
Oxytocin 40IU Oral Transmucosal Films (Solid Suspension, 30 Films) |
| F 009 896 |
Blank Oral Transmucosal Films - For Marketing Purposes (Solid Suspension, 30 Films) |
MAZ® Mixer Sample Formulas
| Formula Number |
Formula Title |
| F 009 668 |
Sildenafil 22mg Oral Transmucosal Films (Solid Suspension, 30 Films)(MAZ) |
| F 009 669 |
Progesterone 40mg Oral Transmucosal Films (Solid Suspension, 30 Films)(MAZ) |
| F 009 674 |
Naltrexone Hydrochloride 4.5mg Oral Transmucosal Films (Solid Suspension, 30 Films)(MAZ) |
| F 009 712 |
Oxytocin 40IU Oral Transmucosal Films (Solid Suspension, 30 Films)(MAZ) |
| F 009 895 |
Blank Oral Transmucosal Films - For Marketing Purposes (Solid Suspension, 30 Films)(MAZ) |
NovaFilm OTF Water Activity
According to USP <795> Pharmaceutical Compounding - Non-Sterile Preparations (to be official November 1st 2023), non-aqueous dosage forms may receive a beyond-use-date (BUD) limit of 180 days. A non-aqueous dosage form is defined as having a water activity (aw) less than 0.6. Testing revealed that NovaFilm OTFs have an aw that is less than 0.6 when dried in the oven or air dried.
| Process |
Description |
Water Activity |
| Oven Dried OTF |
Blank NovaFilm OTF preparation placed in forced air convection oven at 50oC for 1 hour |
0.342 |
| Air Dried OTF |
Blank NovaFilm OTF Preparation placed in well ventilated enclosure at room temperature for 16 hours |
0.287 |
The above results are based on water activity testing of compounded blank OTFs using NovaFilm + Purified Water only. Difference in equipment or variation in process or formulation may impact water activity results.
Testimonials. They said it!
"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)
Frequently Asked Questions
1) What is the water activity for NovaFilm OTFs? Can an API increase the water activity making it above 0.6?
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.
2) What is the Beyond Use Date of NovaFilm OTFs?
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.
3) What are the dimensions of the films?
The dimension of each film, using our NovaFilm OTF Blister Mold is 3 cm x 3 cm.
4) What is the maximum concentration of API that can be used when compounding NovaFilm OTF? Can the NovaFilm OTF be compounded with multiple APIs?
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.
5) Can the NovaFilm OTF be cut?
It is not recommended to cut the NovaFilm OTFs in order to split into multiple doses.
6) Once the film is put into the tray to dispense, how can we perform our quality control weight testing?
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>.
7) What are some differences between NovaFilm OTFs and troches and RDTs?
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.
8) Would the NovaFilm OTF be an appropriate dosage form for those needing mucoadhesion in the esophagus?
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
9) Does the NovaFilm OTF require an oven to dry? What is the best way to dry heat sensitive APIs?
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.
10) Can NovaFilm OTFs be used for veterinary patients? Does this work better for dogs versus cats, and if so, what are the recommended flavors?
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.
11) During the summer months, do the NovaFilm OTF prescriptions need to be shipped with ice packs to the patient?
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.