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Buccal Drug Delivery Systems: Opportunities And Challenges In Buccal, Sublingual Films, Tablets & Sprays - Detailed Analysis On Technologies And Pipeline Development

  • ID: 3429612
  • October 2015
  • Region: Global
  • 70 Pages
  • MP Advisors
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FEATURED COMPANIES

  • Actavis
  • Biodelivery Sciences
  • Generex
  • Intellidrug
  • Neuraxpharm
  • Purdue
  • MORE

Within the oral mucosal cavity, the buccal region offers an attractive route of administration for systemic drug delivery. The mucosa has a rich blood supply and it is relatively permeable. The buccal mucosa offers several advantages for controlled drug delivery for extended periods of time. The mucosa is well supplied with both vascular and lymphatic drainage and first-pass metabolism in the liver and pre-systemic elimination in the gastrointestinal tract are avoided. The area is well suited for a retentive device and appears to be acceptable to the patient. With the right dosage form design and formulation, the permeability and the local environment of the mucosa can be controlled and manipulated in order to accommodate drug permeation. Buccal drug delivery is a promising area for continued research with the aim of systemic delivery of orally inefficient drugs as well as a feasible and attractive alternative for non-invasive delivery of potent peptide and protein drug molecules. In 2014, sales of Suboxone sublingual film totalled approximately $1.3 billion in the U.S. while the total market grew to more than $1.7 billion, driven by a 11 percent increase in prescriptions. In 2014, Bunavail buccal film has received US approval which has similar bioavailability of suboxone with half of the dose of buprenorphine.

Other than drugs used for local actions (antifungal, antiviral), generally controlled substances like buprenorphine, naloxone and fentanyl are preferred to release READ MORE >

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FEATURED COMPANIES

  • Actavis
  • Biodelivery Sciences
  • Generex
  • Intellidrug
  • Neuraxpharm
  • Purdue
  • MORE

1. Introduction

2. Types of dosage forms

3. Transmucosal Delivery Systems: The Mouth

4. Potential Benefits of Buccal Films

5. Limitations and Challenges of Buccal delivery system

6. Buccal Films
- Formulation aspects
- Ideal Characteristic of drugs/excipients for developing Buccal delivery formulations
- Manufacturing Methods
- Solvent casting method
- Hot-melt extrusion
- Semisolid casting
- Solid dispersion
- Rolling
- Physico-Chemical Evaluation of Buccal Films
- Marketed Buccal Films
- Technologies used in Buccal/Sublingual films
- BEMA
- PharmaFilm

7. Buccal Tablets
- Lauriad mucoadhesive technology (Onexo)
- OraVescent Technology (Cima Labs)

8. Sublingual films/Tablets
Buccal/ sublingual formulations approved in the US including generics
Buccal/ sublingual formulations discontinued in the US
Buccal/ sublingual formulations underdevelopment worldwide
Buccal /sublingual formulations approved in Europe

9. Other technologies used in buccal delivery systems
- ArisGen Pharma (ArisCrown technology)
- Mystic Pharma (VersiDoser powder technology)
- Uluru (OraDisc Technology)
- Tesa labtec (PerioPatch) - buccal patch
- Intellidrug (Intraoral drug delivery device)
- Generex Pharma (RapidMist Technology)
- Insys therapeutics (sublingual spray)

10. Oral Thin fast Dissolving Films (OTF) - Ideal Characteristics, Classification and Evaluation
- Auxillium Pharma (PharmForm Tech)
- LTS Lohmann OTF
- IntelGenx OTF
- Tapemark Solustrip technology
- Applied Pharma Research/Tesa Labtec - RapidFilm Technology
- Tesa Labtec Pharma -Mucofilm
- Cynapsus Pharma - Sublingual thin film
- Seoul Pharma -SmartFilm
- Other patented approaches
- XGel film
- Soluleaves
- Wafertab
- Foamburst
- Micap
Companies Covered
- Actavis
- Angelini
- Applied Pharma Research
- Ardana Biosciences
- Auxillium Pharma
- Barr
- Biodelivery Sciences
- Blue fish
- Cynapsus Pharma
- Ethypharm
- Galena
- Galenica
- Generex
- Grunenthal
- Indivior
- Insys
- Insys Therapeutics
- IntelGenx
- Intellidrug
- LTS Lohmann
- Meda Pharma
- MedaPharm
- Mist Pharma
- Mystic Pharma
- Neuraxpharm
- Novadel
- Novel Labs
- Nycomed
- Onexo
- Oriform
- Purdue
- Rosedale Therapeutics
- Roxane
- Sandoz
- Sanofi
- Snoreeze
- Tapemark
- Tesa Labtec Pharma
- Teva

List of Tables

Table 1: List of Approved formulations in mucoadhesive systems worldwide
Table 2: List of Marketed Mucoadhesive Drugs Developed Outside the US
Table 3: List of USFDA approved Buccal formulations
Table 4: List of Sublingual Delivery Formulations Approved by the USFDA
Table 5: List of Discontinued Buccal And Sublingual Formulations from the US market
Table 6: List of Sublingual Formulations Approved in Europe
Table 7: List of Buccal Formulations Approved in Europe
Table 8: List of Mucoadhesive delivery drugs under clinical development
Table 9: Classification of Oral Fast Dissolving Technologies
Table 10: Approved Formulations using Oral Thin Film Technologies
Table 11: Physico-chemical Properties of Mucoadhesive Wafers (Oral Thin Films)

List of Charts:

Chart 1: Drug in Mucoadhesive Thin Film Matrix
Chart 2: Ideal properties of Mucoadhesive polymers
Chart 3: Buccal and Oral Delivery of Peptides through Ariscrown
Chart 4: Oral Peptide Delivery Pipeline from ArisGen Pharma
Chart 5: VersiDoser from Mystic Pharma
Chart 6: Clinical profile of Oral-Lyn in Comparison with Humulin (LLY)

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- Actavis
- Angelini
- Applied Pharma Research
- Ardana Biosciences
- Auxillium Pharma
- Barr
- Biodelivery Sciences
- Blue fish
- Cynapsus Pharma
- Ethypharm
- Galena
- Galenica
- Generex
- Grunenthal
- Indivior
- Insys
- Insys Therapeutics
- IntelGenx
- Intellidrug
- LTS Lohmann
- Meda Pharma
- MedaPharm
- Mist Pharma
- Mystic Pharma
- Neuraxpharm
- Novadel
- Novel Labs
- Nycomed
- Onexo
- Oriform
- Purdue
- Rosedale Therapeutics
- Roxane
- Sandoz
- Sanofi
- Snoreeze
- Tapemark
- Tesa Labtec Pharma
- Teva

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown

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