Chromcore Lifesciences LLP | Services
14239
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Services offered

Speciality pharmaceutical Testing services to support developmental programs, regulatory submissions, stability program, batch Release testing and post approval testing to accelerate partners Filing Process

Metered Dose Inhalers

A metered-dose inhaler (MDI) is a device that delivers a specific amount of medication to the lungs, in the form of a short burst of aerosolized medicine administered by the patient via inhalation.

Dry Powder Inhaler

A dry-powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder.

Nebulizer

a nebulizer or nebuliser (see spelling differences) is a drug delivery device used to administer medication in the form of a mist inhaled into the lungs.

Nasal Spray

A Nasal spray works via actuation of a nasal spray bottle, used to deliver medication via the nostrils

List of services offered

  • Analytical Method Development
  • Analytical Method Validation
  • Analytical Method Transfer
  • Analytical Method Verification (In Case of Compendial/ Validated Method)
  • Reverse Engineering/ De-Formulation/ Q1-Q2
  • Actuator Screening Study
  • In-vitro Bio Equivalence
  • Drug Product Characterization as per CMC Guidance
  • Device Selection and Characterization
  • Drug Delivery Through Spacers
  • Development & GMP Batch Analysis
  • QC Batch Release
  • Stability Testing (Developmental, Registration, commercial & market extension stability studies)
  • Supporting in Identifying Q3 Parameters For ensuring Bio-success
  • RLD Lot selection for Biostudies
  • Device Characterization

List of Services for MDIs

  • Specifications for Drug Product
  • Characterization studies
  • IVIVC Studies

SPECIFICATIONS FOR THE DRUG PRODUCT
  • Description
  • Identification (Primary and secondary)
  • Water Content
  • Dehydrated Alcohol Content
  • Net Content (Fill) Weight
  • Drug Content (Assay)
  • Impurities and Degradation Products
  • Foreign particulate matter
  • Dose Content Uniformity
  • Dose Content Uniformity Through Container Life
  • Particle Size Distribution
  • Aerodynamic particle size distribution
  • Microscopic Evaluation
  • Spray Pattern and Plume Geometry
  • Leak Rate
  • Pressure Testing
  • Valve Delivery (Shot Weight)
DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION
  • Determination of Appropriate Storage Conditions
  • Stability of Primary (Unprotected) Package
  • Temperature Cycling
  • Effect of Resting Time
  • Priming/ Re-priming
  • Effect of Storage on the Particle Size Distribution
  • Drug Deposition on Mouthpiece and/or Accessories
  • Cleaning Instructions
  • Profiling of Actuations Near Canister Exhaustion
  • Plume Geometry
  • Photo stability
  • Profiling of Doses Near Device Exhaustion
  • In Vitro Dose Proportionality
  • Effect of Varying Flow Rates
  • Cleaning Instructions
IN-VITRO BIO- EQUIVALENCE WITH STATISTICAL ANALYSIS (FOR SUBMISSION)
  • APSD (test and Reference) with critical stage PBE
  • Single actuation content (test and Reference) (SAC) with PBE
  • Spray pattern
  • Plume geometry
  • Q1-Q2 comparison
INNOVATIVE IN-VITRO TESTING
  • BRS 3000 -Improving IVIVCs for MDIs
  • Dissolution Testing with and without using anatomical throat
  • APSD study with anatomical throat
  • Particle size and shape of API in formulation
SPECIFICATIONS FOR THE DRUG PRODUCT
  • Description
  • Identification (Primary and secondary)
  • Water or Moisture Content
  • Net Content (Fill) Weight (Device-metered)
  • Drug Content (Assay)
  • Impurities and Degradation Products
  • Dose Content Uniformity
  • Dose Content Uniformity Through Container Life (device-metered)
  • Particle Size Distribution of Emitted Dose
  • Foreign particulate matter
  • Microscopic Evaluation
DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION
  • Determination of Appropriate Storage Conditions
  • Stability of Primary (Unprotected) Package
  • Effect of Varying Flow Rates
  • Effect of Storage on the Particle Size Distribution
  • Dose Build-up and Flow Resistance
  • Effect of Orientation
  • In Vitro Dose Proportionality
  • Effect of Patient Use / In-use stability (as per PIL)
  • Effect of Moisture
  • Photo stability
  • Profiling of Doses Near Device Exhaustion
  • Priming (For Device metered)
  • Fill Weight
  • Device Ruggedness
  • Cleaning Instructions
IN-VITRO BIO- EQUIVALENCE WITH STATISTICAL ANALYSIS (FOR SUBMISSION)
  • APSD (test and Reference) with critical stage PBE
  • Single actuation content (test and Reference) (SAC) with PBE
  • Q1-Q2 comparison
INNOVATIVE IN-VITRO TESTING
  • BRS 3000 -Improving IVIVCs for DPIs
  • Dissolution Testing with and without using anatomical throat
  • APSD study with anatomical throat
  • Surface area
  • Surface energy
  • Powder Rheology (FT4)
  • Particle Size and shape

Services offered for DPIs

  • Specifications for Drug Product
  • Characterization studies
  • IVIVC Studies

List of Services for Nebulizers

  • Specifications for Drug Product
  • Drug product characterization studies for submission
  • Innovative In-Vitro testing
  • In-Vitro Bio- Equivalence analysis (for regulatory submission)

SPECIFICATIONS FOR THE DRUG PRODUCT
  • Description
  • Identification (primary and secondary)
  • pH
  • Osmolarity
  • Assay
  • Unit Dose Content Uniformity
  • Foreign particulate matter
  • Concentration of tonicity agent (if any)
  • Limit of chelating agent / Stabilizing agent (if any)
  • Particle size distribution of drug in immediate container
  • Related substances/ Degradation profile
  • Mean Nebulization time
  • Mean delivered dose
  • Aerodynamic particle size distribution
DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION
  • Determination of Appropriate Storage Conditions
  • Stability of Primary (Unprotected) Package
  • Temperature Cycling
  • Effect of Storage on the Particle Size Distribution
  • Photo stability
  • Droplet size distribution
  • In Vitro Dose Proportionality
  • Drug delivery at 60s
INNOVATIVE IN-VITRO TESTING
  • BRS 2000 -Improving IVIVCs for nebulizers
  • Breathing profile with face masks
  • Particle size and shape of API in formulation
IN-VITRO BIO-EQUIVALENCE ANALYSIS
  • APSD (test and Reference) with critical stage PBE
  • Polymorph form comparison
  • Particle size distribution
  • Particle shape
  • Uniformity of dosage unit
  • Droplet size distribution
  • Q1-Q2 comparison
SPECIFICATIONS FOR THE DRUG PRODUCT
  • Description
  • Identification (primary and secondary).
  • pH
  • Osmolarity
  • Valve Delivery (Shot Weight)
  • Assay
  • Unit Dose Content Uniformity
  • Foreign particulate matter
  • Concentration of tonicity agent (if any)
  • Limit of chelating agent /Stabilizing agent (if any)
  • Droplet size distribution
  • Spray pattern and Plume geometry
  • Related substances/ Degradation profile
DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION
  • Determination of Appropriate Storage Conditions
  • Stability of Primary (Unprotected) Package
  • Temperature Cycling
  • Effect of Storage
  • Droplet size distribution
  • Plume Geometry
  • Photo stability
  • Aerodynamic particle size distribution with suitable expansion chamber
IN-VITRO BIO- EQUIVALENCE WITH STATISTICAL ANALYSIS (FOR SUBMISSION)
  • Single actuation content (test and Reference) (SAC) with PBE
  • Droplet size distribution
  • Drug in small particle/ droplet
  • Spray pattern
  • Plume Geometry
  • Priming and Re-priming
  • Q1-Q2 comparison
INNOVATIVE IN-VITRO TESTING
  • Particle size and shape of API in formulation

Services offered for Nasal Sprays

  • Specifications for Drug Product
  • Characterization studies
  • In-Vitro Bio-Equivalence with Statistical analysis (For submission)
  • Innovative In-Vitro testing

Get in touch with us to discuss your project requirements!