Blister

SinoMab BioScience preclinical results of SM17 on atopic dermatitis (AD) published on International Scientific Journal Allergy

Retrieved on: 
Martedì, Aprile 16, 2024
ILC2, FDA, Idiopathic pulmonary fibrosis, Irritation, Blister, Hope, Safety, T helper cell, Animal, SAE, Research, JAK1, Immunoglobulin G, Therapy, Patient, EAACI, Clinical trial, Atopic dermatitis, Asthma, Immunity, FIC, Pharmaceutical industry

The publication in this international, peer-reviewed and well-cited journal Allergy establishes the scientific validity of SM17 on the treatment of AD, and highlights the potential of SM17 as a revolutionary product in this field.

Key Points: 
  • The publication in this international, peer-reviewed and well-cited journal Allergy establishes the scientific validity of SM17 on the treatment of AD, and highlights the potential of SM17 as a revolutionary product in this field.
  • The Allergy article and the results of the US Phase I study scientifically validated the favourable efficacies and good safety profile of SM17 for treating AD.
  • We are pleased that evidence demonstrating the advantageous therapeutic potential of SM17 for treating AD is scientifically confirmed and endorsed by being published on the renowned peer-reviewed journal Allergy.
  • The preclinical results will be confirmed in human in a proof of concept clinical trial in AD patients that was initiated in April 2024."

IBSA Introduces Two New Dietary Supplements Into the U.S. Market

Retrieved on: 
Martedì, Maggio 7, 2024
Alternative Medicine, Health, Other Health, Fitness & Nutrition, Managed Care, Pharmaceutical, Selenium, FDA, Blister, Iodine, Dietary supplement, Food, IBSA, Piperine, Disease, Nutrient, Multimedia, Micronutrient, Absorption

Manufactured and marketed by IBSA, Syrel and Thirodium are select dietary supplements that contain two vital micronutrients for thyroid support – selenium and iodine respectively.

Key Points: 
  • Manufactured and marketed by IBSA, Syrel and Thirodium are select dietary supplements that contain two vital micronutrients for thyroid support – selenium and iodine respectively.
  • These new dietary supplements are the first two of the company’s line of IBSA Care products.
  • View the full release here: https://www.businesswire.com/news/home/20240506085709/en/
    Manufactured and marketed by IBSA, Syrel and Thirodium are select dietary supplements that contain two vital micronutrients for thyroid support – selenium and iodine respectively.
  • IBSA plans to add to its IBSA Care line of select dietary supplements by introducing other products later this year.

AMERICAN ACADEMY OF DERMATOLOGY SURVEY SHOWS OUTDOOR WORKERS MORE AT RISK FOR SKIN CANCER THAN AVERAGE AMERICANS

Retrieved on: 
Martedì, Maggio 7, 2024
Moles, UPF, American Academy, University, Cancer, Perspiration, Blister, Carcinoma, Risk, Skin, Burn, American Academy of Dermatology, Hand, MD, Dermatology, Sunburn, Skin cancer, Life, Tanning, AAD, Melanoma, SPF, Human, Swimming, Emergency medical services, UV, Clothing, Cosmetics

ROSEMONT, Ill., May 7, 2024 /PRNewswire/ -- A recent American Academy of Dermatology survey of more than 1,000 U.S. adults revealed that outdoor workers – like those who work in construction, landscaping, emergency medical services, and postal delivery – are far more likely to get sunburned and tanned, putting themselves at increased risk for skin cancer, compared to the average American. In recognition of Skin Cancer Awareness Month this May, the AAD encourages everyone – and especially those who work outdoors – to practice safe sun to protect themselves from the sun's harmful rays and reduce their risk of developing skin cancer.

Key Points: 
  • According to the survey, half of outdoor workers were sunburned in 2023, compared to 36 percent reported by the general American population.
  • One in 10 outdoor workers had sunburns severe enough to cause blisters, a rate double that of the general population.
  • And nearly 80 percent of outdoor workers got a tan or darker skin as a result of sun exposure, compared to 67 percent of Americans overall.
  • Tanning and unprotected sun exposure are major risk factors for skin cancer, the most common form of cancer in the United States and one of the most preventable types of cancer.

Pharmaceutical Packaging Market to Be Worth $176.54 Billion by 2031 - Exclusive Report by Meticulous Research®

Retrieved on: 
Venerdì, Maggio 3, 2024
PFS, United Nations, Polyvinyl chloride, Investment, PP, Ampoule, PVC, Polymer, Medicine, Paper, AptarGroup, Gas, Sachet, Blister, Drug discovery, PET, Inhaler, Catalent, Drug packaging, Cellulose, Tablet, Corning Inc., Regulation (European Union), Conditional sentence, Research, Transport, Carbon, QR, Shield, Government, WestRock, Polyethylene, Capsule, Syringe, Glass, Route of administration, Environment, United, Amcor, Growth, Fine chemical

Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.

Key Points: 
  • Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.
  • Key findings in the pharmaceutical packaging market report:
    Among all the materials studied in this report, in 2024, the polymer segment is expected to account for the largest share of 43% of the pharmaceutical packaging market.
  • Among all the packaging types studied in this report, in 2024, the primary packaging segment is expected to account for the largest share of 72% the pharmaceutical packaging market.
  • However, Asia-Pacific pharmaceutical packaging market is expected to growth with the highest CAGR of 8.5% over the forecast period.

Pharmaceutical Packaging Market to Be Worth $176.54 Billion by 2031 - Exclusive Report by Meticulous Research®

Retrieved on: 
Venerdì, Maggio 3, 2024
PFS, United Nations, Polyvinyl chloride, Investment, PP, Ampoule, PVC, Polymer, Medicine, Paper, AptarGroup, Gas, Sachet, Blister, Drug discovery, PET, Inhaler, Catalent, Drug packaging, Cellulose, Tablet, Corning Inc., Regulation (European Union), Conditional sentence, Research, Transport, Carbon, QR, Shield, Government, WestRock, Polyethylene, Capsule, Syringe, Glass, Route of administration, Environment, United, Amcor, Growth, Fine chemical

Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.

Key Points: 
  • Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.
  • Key findings in the pharmaceutical packaging market report:
    Among all the materials studied in this report, in 2024, the polymer segment is expected to account for the largest share of 43% of the pharmaceutical packaging market.
  • Among all the packaging types studied in this report, in 2024, the primary packaging segment is expected to account for the largest share of 72% the pharmaceutical packaging market.
  • However, Asia-Pacific pharmaceutical packaging market is expected to growth with the highest CAGR of 8.5% over the forecast period.

New multi-stakeholder industry initiative launched in the UK to take collaborative action on recycling of primary pharmaceutical packaging

Retrieved on: 
Mercoledì, Maggio 1, 2024
NHS, Public affairs, Nature, Climate, Health, OTC, Blister, Vaccine, Patient, Communication, Recycling, Pharmaceutical industry

CHELTENHAM, England, May 1, 2024 /PRNewswire/ -- The Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA) initiative launched this week to tackle the challenges of recycling medicinal devices and pharmaceutical packaging.

Key Points: 
  • CHELTENHAM, England, May 1, 2024 /PRNewswire/ -- The Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA) initiative launched this week to tackle the challenges of recycling medicinal devices and pharmaceutical packaging.
  • The pharmaceutical industry faces recycling difficulties due to regulations and complex materials, and CiPPPA aims to enhance pharmaceutical packaging's end-of-life management to reduce waste and promote environmental stewardship.
  • Major pharmaceutical companies, global over-the-counter (OTC) brands, and healthcare systems like the NHS have joined the initiative, demonstrating a collective commitment to driving environmental and societal change.
  • By founding and establishing CiPPPA, we are able to deliver enhanced end-of-life for blister packs and related pharmaceutical packaging such as metered dose inhalers and injectables.

Public Advisory - Fake Viagra seized from Jug City store in Scarborough, ON

Retrieved on: 
Venerdì, Aprile 26, 2024
Sale, Pharmacy, Stroke, Safety, Risk, Hearing loss, Nitroglycerin, Natural product, Health, Dizziness, Health Canada, Plasma protein binding, Blister, Counterfeit, Policy, NPN, Prescription drug, Headache, Counterfeit medications, Chest pain, DIN, Dietary supplement

Health Canada has seized counterfeit Viagra from a Jug City store in Scarborough, Ontario (96 Dearham Wood).

Key Points: 
  • Health Canada has seized counterfeit Viagra from a Jug City store in Scarborough, Ontario (96 Dearham Wood).
  • This is in addition to several other unauthorised sexual enhancement products seized from the same store.
  • For more information regarding Health Canada's approach to counterfeit health products, please consult Health Canada's Policy on Counterfeit Health Products .
  • Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM).

Mangoceuticals Subsidiary, MangoRx Mexico, Executes Technical Agreement with Mexican Pharmaceutical Manufacturer for Initial Development and Production of its Mango Erectile Dysfunction (ED) Products

Retrieved on: 
Venerdì, Aprile 12, 2024
USD, Negotiation, Organization, Pharmacy, Production, Blister, Republic, Certification, OTC, Thought, Plant, Erectile dysfunction, Ministry, Marketing, Good, GMP, ED, Bioequivalence, Pharmaceutical industry

Dallas, Texas, April 12, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products in the area of erectile dysfunction (ED), hair growth and hormone replacement therapies is excited to announce that its subsidiary, MangoRx Mexico S.A. de C.V. (“MangoRx Mexico”), has secured and executed a technical agreement with Emifarma S.A. de C.V (“Emifarma”) for the initial stages of development and testing (Bioequivalence and Accelerated Stability, required to obtain registry from COFEPRIS) of the Company’s Mango ED products intended for the Mexican and Latin American markets.

Key Points: 
  • Founded in 1998 by a group of pharmaceutical professionals with experience in Development, Production and Quality, Emifarma is a Mexican company that employs more than 100 workers and has 4 plants that specialize in: Hormonal, Injectable, Additive and Oral Solid (tablet and powdered) products where they serve as a manufacturing partner for some of the most relevant pharmaceutical companies both domestically and internationally, operating in Mexico.
  • Emifarma is Certified for Good manufacturing Practices (GMP) by the following organizations: COFEPRIS, INVIMA, Ministry of Health of the Republic of Peru.
  • Specifically, COFEPRIS is recognized in the following additional countries: Columbia, Ecuador, El Salvador, Chile, Costa Rica and Panama.
  • Efi Karchmer, President of MangoRx Mexico stated, “after visiting, interviewing, and negotiating with many different pharmaceutical manufacturing companies over the past several months, we are very excited about our decision to partner with Emifarma in this endeavor.

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on: 
Giovedì, Aprile 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance

17

Key Points: 
    • 17

      Guideline on the pharmaceutical quality of inhalation and
      nasal medicinal products

      18

      Table of contents

      19

      Executive summary ..................................................................................... 3

      20

      1.

    • Lifecycle management ........................................................................................ 28

      49

      Definitions ................................................................................................. 29

      16

      50
      51

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 2/30

      52

      Executive summary

      53

      This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

      54

      products (EMEA/CHMP/QWP/49313/2005 Corr).

    • Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for

      66

      safety testing (e.g., for excipients and leachables) is also considered.

    • 69

      Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

      70

      analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

      71

      impactor analysis) is not included in this guideline.

    • Scope

      74

      The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

      75

      new marketing authorisation applications, including abridged applications.

    • Liquid inhalation anaesthetics and nasal ointments, creams and gels are

      88

      excluded, however the general principles described in this guideline should be considered.

    • 118

      Different polymorphic forms including any amorphous content could affect the quality or performance

      119

      of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 4/30

      132

      The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

      133

      components required for reasons of stability should be described.

    • Pharmaceutical
      development study

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (c) Extractable
      volume

      Pressurised

      Dry powder

      Preparations for

      Non-

      metered-

      inhalers (DPI)

      nebulisation

      pressurised

      dose

      metered-

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      Yesa

      Yes

      Yes

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      No

      No

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      dose

      Page 5/30

      Table 4.2.1.

    • The last doses delivered by

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 7/30

      179

      the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

      180

      for delivered dose and fine particle dose.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 9/30

      263
      264

      4.2.2.8.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 11/30

      345

      Instructions regarding cold temperature use should be provided in the product information.

    • Finished medicinal
      product

      Pressurised

      Dry powder inhalers

      Preparations for

      metered-

      (DPI)

      nebulisation

      dose

      Nonpressurised
      metered-dose

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      (a) Description

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (b) Assay

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (c) Moisture content

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      specification test

      (d) Mean delivered
      dose
      (e) Uniformity of
      delivered dose

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 15/30

      Table 4.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 16/30

      510

      4.2.5.4.

    • The proposed specification limits should take into account the shelf-life performance of the
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 17/30

      552

      medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 18/30

      586

      All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

      587

      outlined in the Medical Device Regulation (EU) 2017/745.

    • Stability (CTD 3.2.P.8)

      598

      All inhalation medicinal products should be tested on stability against the stability indicating tests

      599

      included in the finished medicinal product specification.

    • Quality data requirements as

      619

      described in this guideline should be met, supplemented by appropriate comparative quality and

      620

      clinical data with respect to the chosen reference medicinal product.

    • 621

      For inhalation medicinal products comparative in vitro data between the abridged application medicinal

      622

      product and the reference medicinal product must be provided.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 20/30

      670

      Nature and contents of container: The type of the device and its components should be listed.

    • Nasal medicinal products

      695

      Inhalation and nasal medicinal products have many similarities and therefore, most of the

      696

      requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

      697

      products.

    • One difference between inhalation and nasal medicinal products is the desired

      698

      particle/droplet size of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 21/30

      704

      5.2.

    • Nasal liquids
      Pharmaceutical
      development
      study

      Pressurised

      Nasal

      metered-

      powders,

      dose nasal

      device-

      spray

      metered

      NonSingledose
      drops

      Multidose
      drops

      Single-

      pressurised

      dose

      multidose

      spray

      metereddose spray

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (d) Extractables /
      leachables

      Yesa

      Yes

      Yesa

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      (f) Particle /
      droplet size
      distribution
      (g) Uniformity of
      delivered dose
      through container
      life
      (j) Actuator /
      mouthpiece
      deposition

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 22/30

      Table 5.2.1.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 23/30

      728

      5.2.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 24/30

      769

      5.2.5.

    • Quality data requirements as described in

      799

      this guideline should be met, supplemented by appropriate comparative quality and clinical data with

      800

      respect to the chosen reference medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 27/30

      849

      5.5.

    • 866

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 28/30

      867

      Definitions
      Activation:

      The act of setting in motion the delivery device.

    • Delivery device:

      The sum of component(s) of the container closure system responsible for
      delivering the active substance to the respiratory tract (inhalation medicinal
      product) or the nasal and/or pharyngeal region (nasal medicinal product).

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 29/30

      Label claim:

      The amount of active substance (usually on a per actuation basis) declared
      on the label of the medicinal product.

    • Nasal medicinal

      A finished medicinal product (including the delivery device, where

      product:

      applicable) whose intended site of deposition is the nasal and/or pharyngeal
      region.

    • 868
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 30/30

Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

Retrieved on: 
Giovedì, Aprile 18, 2024
Eurostat, Diagnosis, Civil service commission, Gene, Mutation, Epidermolysis bullosa, Skin cancer, Patient, Committee, Knowledge, Regulation, Keratin, EMA, IRIS, Protein, Life expectancy, Deformity, Blister, European, Skin, Collagen, COMP, Infection, Sponsor, European Commission, Safety, Unit, Marketing, COL7A1, Medicine, Pharmaceutical industry

Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

Key Points: 


Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn