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Oral film compositions and dosage forms having precise active dissolution profiles

An active substance and oral film technology, which is applied in the field of oral film compositions and dosage forms with precise active substance dissolution profiles, and can solve problems such as inability to use

Pending Publication Date: 2021-06-11
阿奎蒂夫疗法公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, both the film and the process of making a drug delivery system using this dosage form have historically presented some unique challenges in the areas of formulation, processing and pharmacokinetics
In particular, films and the oral dosage units cut therefrom have a number of unfavorable properties that prevented their use in practice until recent advances made films a highly desirable dosage form

Method used

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  • Oral film compositions and dosage forms having precise active dissolution profiles
  • Oral film compositions and dosage forms having precise active dissolution profiles
  • Oral film compositions and dosage forms having precise active dissolution profiles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0285] Embodiment 1-clobazam

[0286] Oral films were prepared with the following compositions shown in Table 1 to compare ground and micronized actives.

[0287] Table 1 : Formulations of Oral Films Containing Milled or Micronized Clobazam

[0288]

[0289] image 3Mean active dissolution profiles of films (N=3) containing milled (D90=106 microns) and micronized (D90=8.3 microns) clobazam and RLD Onfi tablets are shown. Table 2 shows image 3 Some of the graphically depicted data points shown in .

[0290] Table 2: Dissolution Testing for Oral Films Containing Milled or Micronized Clobazam

[0291]

[0292] Thus, oral films comprising micronized clobazam performed better (ie, dissolved significantly faster) than oral films comprising milled clobazam.

Embodiment 2

[0293] Example 2 - Dissolution Study of Oral Film Containing Diazepam

[0294] Diazepam-containing oral films (DBSF) were prepared containing 5 mg and 15 mg of active. The dissolution of 5 mg and 15 mg of DBSF under storage conditions of 12 months at 25°C was tested using conventional dissolution methods and PION technology. The traditional dissolution method used herein is a common method for testing the dissolution characteristics of solid oral dosage forms such as tablets and capsules. The traditional dissolution method utilizes a modified USP apparatus 5 setup, with modified sample holders necessary to keep the membrane immobilized. All other aspects of traditional dissolution methods are similar to those of other solid oral dosage forms, including manual sampling and collection of samples at specific time points, followed by off-line analysis of the samples using HPLC. Traditional dissolution methods are practically limited by the frequency and consistency of manual sam...

Embodiment 3

[0304] Example 3 - Dissolution Study of Oral Films Containing Riluzole

[0305] An oral film (ROSF) containing 50 mg of riluzole was prepared. The dissolution of 50 mg of ROSF after storage at 25°C for about 6 months was tested in 0.1 N HCl (a medium that simulates gastric conditions) using conventional dissolution methods and PION technology. Table 3 above shows the parameters used for the conventional dissolution method and the PION technique for testing ROSF.

[0306] Image 6 is a graph of the active dissolution profile of ROSF as measured by conventional dissolution testing. Figure 7 is a graph of the active substance dissolution profile of ROSF measured by the PION technique. Table 6 presents a number of data points and a comparison of the results obtained by traditional dissolution methods with those obtained using the PION technology.

[0307] Table 6: Active Dissolution Rates and Comparisons for ROSF

[0308]

[0309] According to the calculations presented i...

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Abstract

An oral film in an individual unit dose for delivery of one or more actives is disclosed herein, the film having a precisely calculated and controlled active dissolution profile. A wide variety of actives may be used, including, for example, clobazam, diazepam, or riluzole. Also disclosed are methods of treating a variety of diseases and conditions, for example., epilepsy and seizures, by administering the oral film disclosed herein.

Description

technical field [0001] The present disclosure relates to oral films for the delivery of individual unit doses of one or more actives, such as clobazam, having an average particle size D90 of less than about 160 microns, wherein the oral film has a precise, Controlled active dissolution rates, and methods of treating a variety of conditions including epilepsy and seizures by administering the oral films to a patient in need thereof. Background technique [0002] Active ingredients such as drugs or pharmaceuticals can be prepared in tablet form to allow for accurate and consistent administration. However, this form of preparation and dispensing of the drug has a number of disadvantages, including the necessity to add a large proportion of excipients to obtain a size that can be handled, the need for additional storage space for larger drug forms, and the fact that dispensing involves counting tablets, which have inaccurate trends. Furthermore, it is estimated that as many as...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/70A61K31/551A61P25/08
CPCA61K9/006A61K9/0056A61K9/7007A61K31/551A61P25/08Y02A50/30A61K31/5513
Inventor 亚历山大·马克·朔贝尔斯蒂芬·瓦加基文森特·J·博诺苏珊·舒马德克里斯托弗·詹姆斯·桑蒂
Owner 阿奎蒂夫疗法公司
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