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頬粘膜下薬剤送達システム:バッカル&舌下フィルム・タブレット・スプレーの市場機会と課題 - 各種技術およびパイプライン開発動向の詳細分析

Drug Delivery Systems: Opportunities And Challenges In Buccal, Sublingual Films, Tablets & Sprays -Detailed analysis on Technologies BUCCAL and Pipeline Development

発行 MP Advisors 商品コード 341195
出版日 ページ情報 英文 70 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=113.97円で換算しております。
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頬粘膜下薬剤送達システム:バッカル&舌下フィルム・タブレット・スプレーの市場機会と課題 - 各種技術およびパイプライン開発動向の詳細分析 Drug Delivery Systems: Opportunities And Challenges In Buccal, Sublingual Films, Tablets & Sprays -Detailed analysis on Technologies BUCCAL and Pipeline Development
出版日: 2015年10月01日 ページ情報: 英文 70 Pages
概要

頬粘膜下による薬剤送達は、経口では非効率な薬剤の全身送達を目指し、また、強力なペプチド・タンパク質分子を非侵襲的に送達する実現可能で魅力的な代替手段として、継続的研究が有望視されている分野です。Suboxone舌下フィルムの2014年における米国での売上規模は約13億ドルであり、市場全体の規模は17億ドルを超えています。

当レポートでは、上市済みおよび開発中のバッカル剤・舌下剤の市場について調査し、経粘膜送達システムおよび頬粘膜送達システムの概要、メリット・デメリット、バッカルフィルムの特徴・製造法・物理化学的分析、上市済み製品と概要および動向、パイプラインの動向、各種送達技術の開発動向などをまとめています。

第1章 イントロダクション

第2章 剤形の各種タイプ

第3章 経粘膜送達システム:経口

第4章 バッカルフィルムの潜在的メリット

第5章 頬粘膜送達システムの制約と課題

第6章 バッカルフィルム

  • 製剤の特徴
  • バッカル送達用製剤の開発において理想的な薬剤の特徴・補形
  • 製造法
    • 溶剤注入成形
    • ホットメルト押出し
    • 半固体注入成形
    • 固体分散
    • ローリング
  • バッカルフィルムの物理化学的分析
  • 上市済みバッカルフィルム
  • バッカル/舌下フィルムに用いられる技術
    • BEMA
    • PharmaFilm

第7章 バッカル錠

  • Lauriad粘膜付着性技術 (Onexo)
  • OraVescent Technology (Cima Labs)

第8章 舌下フィルム/錠

  • 米国で承認済みのバッカル/ 舌下剤 (ジェネリック薬を含む)
  • 米国で開発が中止されたバッカル/ 舌下剤
  • 世界で開発中のバッカル/ 舌下剤
  • 欧州で承認済みのバッカル /舌下剤

第9章 バッカル送達システムに用いられるその他の技術

  • ArisGen Pharma (ArisCrown技術)
  • Mystic Pharma (VersiDoser粉末技術)
  • Uluru (OraDisc Technology)
  • Tesa labtec (PerioPatch):バッカルパッチ
  • Intellidrug (口腔内薬剤送達デバイス)
  • Generex Pharma (RapidMist Technology)
  • Insys therapeutics (舌下スプレー)

第10章 迅速溶解性経口フィルム (OTF):理想的な特徴・分類・評価

  • Auxillium Pharma (PharmForm Tech)
  • LTS Lohmann OTF
  • IntelGenx OTF
  • TapemarkのSolustrip技術
  • Applied Pharma Research/Tesa Labtec:RapidFilm Technology
  • Tesa Labtec Pharma:Mucofilm
  • Cynapsus Pharma:舌下フィルム
  • Seoul Pharma:SmartFilm
  • その他の特許取得済みアプローチ
    • XGel film
    • Soluleaves
    • Wafertab
    • Foamburst
    • Micap

調査対象企業

  • 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

図表

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目次
Product Code: 4484

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 the drug through buccal formulations. However, testosterone (striant) to treat low testosterone levels in men also approved through use of buccal system of delivery. In the US, drugs such as Isosorbide dinitarte, ergoloid delivered sublingually have been discontinued and nitroglycerin has been replaced with sublingual metered spray. Ergomar (ergotamine tartarate) marketed by Rosedale therapeutics is the only sublingual tablets available in the US market, priced $15 per pill. Subsys (fentanyl) developed by Insys therapeutics was the recent sublingual spray approved in the US for the treatment of breakthrough cancer pain. Global pharma companies such as Biodelivery Sciences, Bioalliance pharma (Onexo), Meda pharma, Orexo, Generex, Teijin are actively involved in developing oral mucoadhesive buccal delivery systems while sublingual technology have been used by Teva, Sun pharma, Grunenthal, Neurax, Angelini, Sandoz, Ethypharm, Arrow generics, Purdue and Actavis pharma. Sublingual spray technology have been employed by the companies such as Insys therapeutics, Perrigo, Mist pharm, Regency, Novadel, Generex, GW Pharma and Pohl Boskamp in developing potential drugs for the patients.

Ease of administration and better compliance offered by delivering through buccal route offers advantages for patients and physicians over other Invasive route and oral ingestion will drive the market further in positive directions going forward. Novel buccal delivery such as soluble thin films, mucoadhesive films and rapidmist spray offers newer route of delivery for the generics that has lesser patients compliances.

This report will provide detailed analysis on buccal delivery systems in broader pharma market in finding companies and technologies and complexities involved in developing this unique high potential delivery system

Table of Contents

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

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)

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)
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