Mucoadhesive oral films: The potential for unmet needs

Silva, Branca M.A.; Borges, Ana Filipa; Silva, Cláudia; Coelho, Jorge F. J.; Simões, Sérgio

doi:10.1016/j.ijpharm.2015.08.038

Cited by 57 publications

(44 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Though theoretically envisioned well for the purpose, in practice, the device was large and bulky, hence, difficult for patients to carry around and could not be used with discretion. Other factors that contributed to the failure of Exubera include; the unimpressive Figure 3: Summary of advantages and disadvantages of the main five non-invasive delivery routes (buccal, oral, nasal, pulmonary and transdermal) for insulin delivery based on information from several reviews [40][41][42][43][44][45][46][47][48].…”

Section: Pulmonary Insulin Deliverymentioning

confidence: 99%

A review of non-invasive insulin delivery systems for diabetes therapy in clinical trials over the past decade

Easa

Alany

Carew

et al. 2019

Drug Discovery Today

View full text Add to dashboard Cite

At present, the main form of insulin administration is the invasive subcutaneous route, and this for many individuals means managing their glucose levels with multiple daily injections, which is both painful and difficult to administer chronically. To increase patient compliance, products are slowly reaching the market that are more patient friendly such as the insulin patch-pump systems, like Omnipod and V-Go, but also the inhaled insulin Afrezza® and the buccal insulin Oral-lyn™. This review outlines the history of insulin, the various options that are currently available in practice for insulin delivery, and the non-invasive delivery systems that have managed to enter the different stages of clinical trials in the past decade.

show abstract

Section: Pulmonary Insulin Deliverymentioning

confidence: 99%

A review of non-invasive insulin delivery systems for diabetes therapy in clinical trials over the past decade

Easa

Alany

Carew

et al. 2019

Drug Discovery Today

View full text Add to dashboard Cite

show abstract

“…The therapeutic areas for these novel products include pain, allergy, diabetes, and nicotine dependence 45. BBUP with BEMA technology has been approved for the treatment of chronic pain severe enough to require daily, around-the-clock, long-term opioid therapy for which alternative treatment options are inadequate 46…”

Section: Bema Technology and Buprenorphinementioning

confidence: 99%

Management of moderate to severe chronic low back pain with buprenorphine buccal film using novel bioerodible mucoadhesive technology

Pergolizzi¹,

Raffa²,

Fleischer³

et al. 2016

JPR

View full text Add to dashboard Cite

With a global prevalence of ~9%–12%, low back pain (LBP) is a serious public health issue, associated with high costs for treatment and lost productivity. Chronic LBP (cLBP) involves central sensitization, a neuropathic pain component, and may induce maladaptive coping strategies and depression. Treating cLBP is challenging, and current treatment options are not fully satisfactory. A new BioErodible MucoAdhesive (BEMA®) delivery system for buprenorphine has been developed to treat cLBP. The buccal buprenorphine (BBUP) film developed for this product (Belbuca™) allows for rapid delivery and titration over a greater range of doses than was previously available with transdermal buprenorphine systems. In clinical studies, BBUP was shown to effectively reduce pain associated with cLBP at 12 weeks with good tolerability. The most frequently reported side effects with the use of BBUP were nausea, constipation, and vomiting. There was no significant effect on the QT interval vs placebo. Chronic pain patients using other opioids can be successfully rotated to BBUP without risk of withdrawal symptoms or inadequate analgesia. The role of BBUP in managing cLBP remains to be determined, but it appears to be a promising new product in the analgesic arsenal in general.

show abstract

“…Mucoadhesive films are dosage forms that remain in intimate contact with the oral mucosa and release the drug for prolonged period either for local or systemic action. The release of drug can either be in the direction of oral mucosa or towards the oral cavity . The bioavailability of drugs that undergo extensive first‐pass metabolism after oral administration could be improved by formulating it as a mucoadhesive film.…”

Section: Introductionmentioning

confidence: 99%

“…The release of drug can either be in the direction of oral mucosa or towards the oral cavity. [7] The bioavailability of drugs that undergo extensive first-pass metabolism after oral administration could be improved by formulating it as a mucoadhesive film. These dosage forms are particularly advantageous for paediatric and geriatric populations as they are easy to administer and danger of choking is minimal.…”

Section: Introductionmentioning

confidence: 99%

Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot-melt extrusion technology

Bhagurkar

Darji

Lakhani

et al. 2019

Journal of Pharmacy and Pharmacology

View full text Add to dashboard Cite

Objectives To investigate the effects of formulation composition on the physico‐chemical and drug release properties of mucoadhesive buccal films prepared by melt extrusion technology, using a response surface methodology. Methods Salbutamol sulphate, an antiasthmatic drug was used for this study. Klucel hydroxypropylcellulose (HPC) EF (film‐forming polymer), Benecel hydroxypropylmethylcellulose (HPMC) K‐15M (drug release retardant) and polyethylene glycol (PEG) 4500 (plasticiser) were the three independent factors utilised for the study. The responses were fitted to a full quadratic model and P‐values for each of the factors were used to determine their significance on the film characteristics. Key findings Films were successfully extruded using the corotating twin‐screw extruder. The torque during extrusion was found to be significantly affected by all the three factors and no interaction between factors was observed. A significant interaction was observed between HPC and PEG 4500 for stiffness of films. For disintegration time and swelling index, a significant interaction was found between HPC and HPMC. The in vitro % drug release was directly correlated with HPMC content and not with other factors and varied from 69–89% at 4 h. Conclusions The influence of extrusion process and formulation parameters on salbutamol sulphate films was elucidated, indicating the use of melt extrusion as a feasible method for film preparation.

show abstract

Mucoadhesive oral films: The potential for unmet needs

Cited by 57 publications

References 38 publications

A review of non-invasive insulin delivery systems for diabetes therapy in clinical trials over the past decade

A review of non-invasive insulin delivery systems for diabetes therapy in clinical trials over the past decade

Management of moderate to severe chronic low back pain with buprenorphine buccal film using novel bioerodible mucoadhesive technology

Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot-melt extrusion technology

Contact Info

Product

Resources

About