BEMA Film Analysis

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BEMA film was designed to rapidly deliver a drug across the mucosa when fast onset of effect is required and to formulate drugs with poor oral bioavilability[1]
Buprenorphine has very poor oral bioavailability(~10%) due to extensive first pass metabolism[3] and hence cannot be formulated as an oral tablet. IM, IV, suppository, transdermal, sublingual and buccal administration routs all bypass first pass metabolism and hence increase the bioavailability however IM, IV or suppositories would be inconvenient to administer regularly therefore only transdermal, sublingual and buccal formulations are suitable dosage forms for treatment of opioid dependence.
Transdermal administration of buprenorphine has an absolute bioavailability of approximately
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The adhesive film prevents patients from moving the product around in the mouth therefore avoiding interpatient variability present with sublingual tablet formulations.
68% of patients who reported constipation with Suboxone tablets or films did not report constipation at 12 weeks after switching to BUNAVAIL. This may be due to lower levels of buprenorphine swallowed into the GI and lower levels of the metabolite Norbuprenorphine [7]
The increase in bioavailability compared with sublingual tablets also reduces the total quantity of drug needed in the formulation by half. Coupled with the withdrawal inducing effect of naloxone if injected, makes this formulation one with a very low abuse potential.
In terms of patient use, the BEMA film is easy to use, offers discreet placement, allows patients to talk while the film is adhered to the cheek and has a pleasant citrus taste. These factors all act to improve patient compliance to the
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MonoSol and RB pharm claim patent infringement relating to the manufacturing process of the BEMA buccal film. BDSI holds that their patents and manufacturing processes do not infringe on any of the patents held by the plaintiffs.[6] Bunavail is an emerging competitor with Suboxone buprenorphine/naloxone sublingual film, Subsolv buprenorphine/naloxone sublingual tablet using Orexo’s proprietary sublingual drug delivery technology and Subxone sublingual tablets who's users are being largely switched to either suboxone film or generic buprenorphine/naloxone tablet formulations that were launched in early 2013
Currently Bunavail has a very small (<1%) market share while suboxone film holds an the largest (~60%) (Table 1.)
The disadvantage in comparison with other buprenorphine/naloxone products is that smaller dose on packet may mislead patients switched from sublingual tablets to believe that the drug will not be as effective even though the exposure is the same and hence may prefer to remain on the higher dose of sublingual tablets or take more than the prescribed dose. Some may even experiance psychological symptoms of

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