Solubility | Jotup

MD Logic Health® Introduces Their New Low Molecular Bioactive Colostrum

Retrieved on:

Martedì, Aprile 30, 2024

Sale, Digestion, Protein, Solubility, Pinnacle, Milk, Cytokine, MD, Logic, Probiotic, Peptide, Colostrum, Immunity, Absorption, Nutritional science, Fats, Dairy

MIAMI, April 30, 2024 /PRNewswire-PRWeb/ -- In an era where gut health is paramount, MD Logic Health® has once again raised the bar with the introduction of its Low Molecular Bioactive Colostrum), a new pinnacle in health supplements for superior gut health and overall well-being. Known for their unwavering dedication to excellence and innovation, MD Logic Health®'s latest formulation offers unparalleled potency, purity, and efficacy.

Key Points:

MD Logic Health® raises the bar in gut health innovation with its new Low Molecular Bioactive Colostrum, offering unmatched potency and efficacy.
- Wesley Ramjeet, CEO of MD Logic Health®
As the market's demand for effective gut health solutions intensifies, MD Logic Health® delivers a compelling answer with its Low Molecular Bioactive Colostrum.
The Low Molecular Bioactive Colostrum is sourced from all-natural, hormone-free grass-fed cattle maintained on a carefully selected, nutrient-rich diet.
MD Logic Health®'s Low Molecular Bioactive Colostrum is a revolution in wellness, designed to meet the needs of modern health-conscious consumers.

DolCas Biotech demonstrates Curcugen® in chocolate at Vitafoods

Retrieved on:

Martedì, Aprile 30, 2024

Capsule, Solubility, Polysaccharide, Health, Tablet, Food, Curcumin, Medicine, DMC, Drink, Absorption, Plasma

LANDING, N.J., April 30, 2024 /PRNewswire/ -- DolCas Biotech, LLC will introduce a new prototype of delicious chocolate laced with its flagship curcumin ingredient Curcugen® to demonstrate its versatility in functional foods and beverages. The tasty reveal will occur at the Vitafoods Europe in Geneva, booth #N217, May 14-16, 2024.

Key Points:

"We bring functional chocolate to Switzerland—a country famous for its chocolate—to reinvent the chocolate segment with added better-for-you value," asserts Dr. Shavon Jackson-Michel, Director of Medical & Scientific Affairs for DolCas Biotech.
To tackle this, DolCas partnered with a boutique chocolate maker to create the perfect chocolate with all the sensory experience consumers crave.
The collaboration resulted in an indulgent chocolate bite enriched with Curcugen's anti-inflammatory and antioxidant benefits to suit consumers desiring innovative delivery systems for wellness ingredients.
The 2x2-inch chocolate square is individually wrapped for visitors at Vitafoods Europe to sample the fun, tasty treat.

EQS-News: Marinomed Biotech AG enters Solv4U R&D collaboration with Brazilian pharmaceutical company Aché Laboratórios

Retrieved on:

Venerdì, Maggio 3, 2024

Solubility, Partnership, Research, Drug development, API, Pharmaceutical industry

Korneuburg, Austria, 25 April 2024 – Marinomed Biotech AG (VSE:MARI) announces the establishment of an R&D collaboration under its Solv4U platform with Aché Laboratórios Farmaceuticos S.A., one of the largest and most innovative pharmaceutical companies in Brazil.

Key Points:

Korneuburg, Austria, 25 April 2024 – Marinomed Biotech AG (VSE:MARI) announces the establishment of an R&D collaboration under its Solv4U platform with Aché Laboratórios Farmaceuticos S.A., one of the largest and most innovative pharmaceutical companies in Brazil.
Aché is known for its leadership in prescription medicines, and its commitment to developing innovative solutions for unmet medical needs.
Through its Solv4U partnership program, Marinomed offers its proprietary Marinosolv solubilization technology to customers from pharma and biotech to address solubility and bioavailability issues and support the formulation development of active pharmaceutical ingredients (APIs).
Cornelia Siegl, Head of Solv4U, commented: "We are excited to embark on this journey with Aché and look forward to the collaboration on this Solv4U project with such an innovative partner.

Eyenovia Provides Clinical and Scientific Update on FDA-Approved Products Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension

Retrieved on:

Giovedì, Aprile 25, 2024

Pain, FDA, Clobetasol, Inflammation, Phenylephrine, The central science, Solubility, Food, Research, State university system, Mydriasis, OD, Patient, Annual general meeting, Tropicamide, ARVO, Pharmaceutical industry

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today provided an update on its two FDA-approved products.

Key Points:

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today provided an update on its two FDA-approved products.
Eyenovia is planning to launch clobetasol later this summer, as a complement to Mydcombi, the company’s commercially available mydriasis agent.
“We look forward to incorporating this technology in future products, as well as launching clobetasol which uses APNT.
Clobetasol will be the first new ophthalmic steroid in many years, participating in a market estimated to be worth in excess of $1.3 billion annually.”

Pasithea Therapeutics Announces the First Cohort has Completed the Initial Dosing in its Phase 1 Trial Evaluating PAS-004 in RAS, NF1 and RAF Mutated Cancers

Retrieved on:

Mercoledì, Aprile 24, 2024

Mutation, Solubility, Safety, Pharmacokinetics, RAS, Half-life, MEK, NF1, BRAF, Patient, MAPK, RAF, Clinical trial, KTTA, SAN, Pharmaceutical industry

PAS-004 is being evaluated in a Phase 1 multicenter open label clinical trial ( NCT06299839 ) in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition.

Key Points:

PAS-004 is being evaluated in a Phase 1 multicenter open label clinical trial ( NCT06299839 ) in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition.
“Completion of the initial dosing of the first cohort of 3 subjects is a significant milestone in Pasithea’s mission towards developing PAS-004 as a potential best-in-class next-generation MEK inhibitor.
PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life which may provide better compliance rates, as well as improved efficacy in NF1.
Macrocycles are known to exhibit stronger binding, better solubility and longer half-life with more selectivity and less off target effect as compared to acyclic small molecules.

Savanna Ingredients GmbH Appoints Palmer Holland as Exclusive Distribution Partner

Retrieved on:

Giovedì, Aprile 25, 2024

Psicose, Sucrose, Nutrition, Solubility, GMO, Partnership, Food industry, Metabolism, Cellobiose, Convenience food

CLEVELAND, April 24, 2024 /PRNewswire/ -- Savanna Ingredients GmbH and Palmer Holland, Inc. have signed an exclusive distribution partnership for crystalline Allulose and Cellobiose in the USA and Canada markets.

Key Points:

CLEVELAND, April 24, 2024 /PRNewswire/ -- Savanna Ingredients GmbH and Palmer Holland, Inc. have signed an exclusive distribution partnership for crystalline Allulose and Cellobiose in the USA and Canada markets.
"Savanna Ingredients GmbH's value proposition and focus on quality and sustainability aligns well with Palmer Holland's mission to source high-quality natural ingredients designed to meet the needs of tomorrow," said Brendan Michel, Palmer Holland Business Manager - Health and Nutrition.
Allulose does not dock in the body, the calories are not metabolized but excreted," said Ralph Cartarius, Managing Director of Savanna Ingredients GmbH.
Another promising innovation from Savanna Ingredients GmbH is the functional carbohydrate Cellobiose.

InnoGI Technologies and Simulations Plus Combine Forces to Offer Next-Level Modeling Solutions for the Prediction of Oral Drug Performance

Retrieved on:

Mercoledì, Aprile 17, 2024

Simulations Plus, Pharmacopoeia, USP, TIM, Solubility, Doctor of Philosophy, United States Pharmacopeia, PBPK, ADMET, MBA, Excipient, Medical device

DELFT, Netherlands, April 17, 2024 /PRNewswire/ -- InnoGI Technologies (formerly The TIM Company) is pleased to announce an exciting, market-driven collaboration with Simulations Plus to combine its TIM Technology, part of the InnoGI SurroGUT™ platform, with the GastroPlus® and ADMET Predictor® modelling software offered by Simulations Plus.

Key Points:

DELFT, Netherlands, April 17, 2024 /PRNewswire/ -- InnoGI Technologies (formerly The TIM Company) is pleased to announce an exciting, market-driven collaboration with Simulations Plus to combine its TIM Technology, part of the InnoGI SurroGUT™ platform, with the GastroPlus® and ADMET Predictor® modelling software offered by Simulations Plus.
Understanding drug behavior following oral administration is important because solubility and absorption profiles affect dosing and efficacy.
However, dynamic interactions between sparingly-soluble active pharmaceutical ingredients, excipients and the gastrointestinal (GI) environment are oversimplified in all static in vitro dissolution models and are very difficult to model using purely computational (in silico) approaches.
This will improve the predictive accuracy of physiologically-based pharmacokinetic (PBPK) models, physiologically-based biopharmaceutics models (PBBMs), and facilitate the development of mechanistic IVIVCs."

Neogen® Farm Fluid MAX Disinfectant Launches Across Great Britain Livestock & Poultry Markets

Retrieved on:

Giovedì, Aprile 11, 2024

Solubility, CMK, Neogen, Bacteria, Veterinary medicine, Mycoplasma, Livestock, Virus, Biological life cycle, Poultry farming

GREATER MANCHESTER, England, April 11, 2024 /PRNewswire/ -- Neogen® Corporation (NASDAQ: NEOG) announced today that it has launched Neogen® Farm Fluid MAX in Great Britain and will soon be available in other European markets, subject to global registrations and notifications.

Key Points:

GREATER MANCHESTER, England, April 11, 2024 /PRNewswire/ -- Neogen® Corporation (NASDAQ: NEOG) announced today that it has launched Neogen® Farm Fluid MAX in Great Britain and will soon be available in other European markets, subject to global registrations and notifications.
This dual-action disinfectant is designed for challenging farm conditions and is formulated for use as part of a Neogen Pathogen Programme.
An extension of the respected Farm Fluid product line, Neogen Farm Fluid MAX is specially designed to be applied as part of coccidiosis control protocols.
The typical recommendation would be to utilize Neogen Farm Fluid MAX as the third step of the programme, following the cleaning of all surfaces with Farm-Foam™ EVO and an initial application of Neogen Viroxide Super™ disinfectant.

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

Retrieved on:

Giovedì, Aprile 18, 2024

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

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

Retrieved on:

Giovedì, Aprile 18, 2024

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