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市場調查報告書

口腔黏膜遞藥系統:口腔、舌下膜·含片·噴霧的市場機會與課題 - 各種技術及開發平台開發趨勢的詳細分析

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

出版商 MP Advisors 商品編碼 341195
出版日期 內容資訊 英文 70 Pages
商品交期: 最快1-2個工作天內
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口腔黏膜遞藥系統:口腔、舌下膜·含片·噴霧的市場機會與課題 - 各種技術及開發平台開發趨勢的詳細分析 Drug Delivery Systems: Opportunities And Challenges In Buccal, Sublingual Films, Tablets & Sprays -Detailed analysis on Technologies BUCCAL and Pipeline Development
出版日期: 2015年10月01日 內容資訊: 英文 70 Pages
簡介

透過口腔黏膜的藥物遞送,是目前正在持續研究,並可望取代口服低效率的全身性藥物遞送,或是可實現非侵入式來遞送強力胜肽蛋白分子之具有魅力的方法的領域。Suboxone舌下膜在2014年美國的銷售額規模約為13億美金,市場整體規模超過17億美金。

本報告提供已上市及正在開發的口含片·舌下藥劑的市場相關調查,提供您黏膜遞送系統及口腔黏膜遞送系統概要,優點及缺點,舌下膜的特徵·製造法·物理化學性分析,彙整已上市產品和概要及趨勢,開發平台趨勢,各種遞送技術的開發趨勢等資料。

第1章 簡介

第2章 劑型的各種類型

第3章 黏膜遞送系統:口服

第4章 舌下膜的潛在優點

第5章 口腔黏膜遞送系統的限制與課題

第6章 舌下膜

  • 製劑的特徵
  • 口含片遞送用製劑的開發中理想的藥物特徵·補形
  • 製造法
    • 溶劑注射成型
    • 熱熔擠壓
    • 半固體注射成型
    • 固體分散
    • 滾動
  • 舌下膜的物理化學的分析
  • 已上市舌下膜
  • 口含片/舌下薄膜所採用的技術
    • BEMA
    • PharmaFilm

第7章 口含片鎖

  • Lauriad粘膜黏附技術 (Onexo)
  • OraVescent Technology (Cima Labs)

第8章 舌下薄膜/粒

  • 美國已通過核準的口含片/ 舌下藥劑 (含學名藥)
  • 美國中止開發的口含片/ 舌下藥劑
  • 全球正在開發的口含片/ 舌下藥劑
  • 歐洲已通過核準的口含片 /舌下藥劑

第9章 口含片遞送系統所採用的其他技術

  • ArisGen Pharma (ArisCrown技術)
  • Mystic Pharma (VersiDoser粉末技術)
  • Uluru (OraDisc Technology)
  • Tesa labtec (PerioPatch):口含片貼片
  • Intellidrug (口腔內藥物輸送設備)
  • Generex Pharma (RapidMist Technology)
  • Insys therapeutics (舌下噴霧)

第10章 迅速溶解性口服薄膜 (OTF):理想的特徵·分類·評估

  • Auxillium Pharma (PharmForm Tech)
  • LTS Lohmann OTF
  • IntelGenx OTF
  • Tapemark的Solustrip技術
  • Applied Pharma Research/Tesa Labtec:RapidFilm Technology
  • Tesa Labtec Pharma:Mucofilm
  • Cynapsus Pharma:舌下薄膜
  • Seoul Pharma:SmartFilm
  • 其他取得專利的方法
    • XGel film
    • Soluleaves
    • Wafertab
    • Foamburst
    • Micap

調查對象企業

  • 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

圖表

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目錄
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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