LogoCoat
Case Study — Surface Transformation

Micron-precise.
Audit-ready.
Every batch.

Polymer film coating for tablets and pellets — controlling release, masking actives, and protecting stability through 36 months of shelf life.

Uncoated pharmaceutical tablet showing chalky surface with visible imperfections and rough texture under laboratory lighting
Before — Uncoated

Surface RSD: ±8.4% · Friability: 1.2%

Coated pharmaceutical tablet with smooth satin polymer film catching controlled light source showing flawless uniform surface
After — Coat Applied

Surface RSD: ±1.2% · Friability: <0.1%

Live
±1.2%RSD

Coating Uniformity

Across all pan & fluid-bed batches

Live
100%USP

Dissolution Compliance

Every batch within pharmacopeial tolerance

0483s

FDA Audit Citations

11 consecutive inspections — zero observations

Process Capabilities

Three platforms.
One coating partner.

3 PLATFORMS ACTIVE
Perforated Pan

Pan Coating

500
kg max batch

Side-vented perforated pan with continuous air flow. Ideal for film coating, sugar coating, and moisture barrier applications on solid oral dosage forms.

Pan Diameter
1200 mm
Spray Rate
0–800 g/min
Inlet Temp
40–90 °C
Equipment
GEA Compu-Lab
Film coatingSugar coatingMoisture barrierColor coating
Current Utilization87%
Bottom-Spray

Fluid-Bed Wurster

150
kg max batch

Wurster bottom-spray configuration for uniform pellet and bead coating. Achieves tightest coat weight distribution for modified-release profiles.

Column Diameter
600 mm
Spray Rate
0–200 g/min
Particle Size
100 µm–5 mm
Equipment
Glatt GPCG
Extended releaseEnteric coatingPellet layeringTaste masking
Current Utilization72%
Rotor Processor

Dry Powder Layering

80
kg max batch

Solvent-free powder layering for API loading onto inert seeds. Eliminates solvent residue risk for moisture-sensitive compounds.

Rotor Diameter
450 mm
Powder Feed
Gravimetric
Binder Spray
Aqueous only
Equipment
Vector FL
API layeringSolvent-freeControlled loadingMulti-particulate
Current Utilization58%
Regulatory Credentials

Audit-ready.
On first walk-through.

Every credential listed below is current, verifiable, and available for client review during qualification. No exceptions.

21 CFR 211
11
Consecutive Clean Inspections

cGMP Compliant Facility

Full compliance with 21 CFR Parts 210 and 211. Most recent FDA inspection: Q4 2025. Zero 483 observations issued across all inspections since facility qualification.

FDA RegisteredISO 9001:2015cGMP Certified
DEA Licensed
Sch. II–V
Controlled Substance Authorization

Schedule II–V Handling

Active DEA Schedule II through V manufacturing registration. Dedicated controlled substance handling suites with independent access controls and audit trails.

DEA Schedule IIDEA Schedule III–VChain of Custody
ICH Q1A–Q1F
36 mo
Long-Term Stability Supported

ICH Stability Compliance

On-site ICH-compliant stability chambers for 25°C/60% RH and 40°C/75% RH storage. Full photostability per ICH Q1B. Data packages formatted for ANDA/NDA submission.

ICH Q1AICH Q1BICH Q1EANDA Ready
ANDA Support
47+
ANDAs Supported to Date

Regulatory Package Delivery

Full CMC section support for ANDA filings. Dissolution method development, comparative dissolution studies, and scale-up reports included in every commercial engagement.

CMC WritingDissolution StudiesScale-Up Reports
Audit Ready
100%
First-Walk-Through Audit Pass

Client Audit Pass Rate

Every client quality audit has passed on first walk-through. Pre-audit readiness reviews and gap assessments available as part of onboarding for all commercial partners.

Client AuditsPre-Audit ReviewGap Assessment
ISO 14644
ISO 7
Coating Suite Classification

Cleanroom Classification

Coating suites classified to ISO 7 (Class 10,000). Continuous environmental monitoring with HEPA-filtered, pressure-cascaded air handling. Quarterly particle count certification.

ISO 7 CleanroomHEPA FiltrationEM Program
Client Case Studies

Outcomes first.
Context on demand.

Every engagement below was delivered on time, within budget, and to specification. Click any card to read the full story.

14-day turnaround

Modified-release reformulation

Mid-cap generic manufacturer · Small molecule — BCS Class II

Modified ReleaseANDA

Challenge

ANDA timeline at risk. Original coating vendor failed dissolution specification on three consecutive batches at pilot scale. Client needed a new coating partner to qualify, reformulate, and deliver passing dissolution data within a two-week window before FDA submission deadline.

Solution

Coat team conducted a 48-hour feasibility assessment using existing dissolution data. Reformulated HPMC-based extended-release film with optimized plasticizer ratio and spray rate profile. Two pilot batches completed in six days. Both passed USP Apparatus II dissolution at all time points.

Result

ANDA submitted on schedule. Zero reformulation cost overrun. Dissolution data accepted without FDA information request.

Key Metrics

14 days
Turnaround
2 of 2
Batches Run
100%
USP Pass Rate
$0
Cost Overrun
≥90% bitterness reduction

Pediatric taste masking

Specialty pharma CDMO · Antibiotic — extremely bitter active

Taste MaskingPediatric

Challenge

Fixed-dose combination product for pediatric indication. Active ingredient registers 10/10 on bitterness scale via electronic tongue. Previous Eudragit E coating failed at gastric pH, releasing bitter drug in the mouth before reaching stomach.

Solution

Coat developed a dual-layer coating system: inner Eudragit E layer for bitterness masking, outer enteric layer for pH-triggered release. Fluid-bed Wurster process with sub-100-micron pellets. Electronic tongue validation confirmed ≥90% bitterness suppression at salivary pH.

Result

Product entered Phase II palatability study. Pediatric panel acceptance rate 94%. Technology transferred to commercial-scale Wurster at client facility with full process documentation.

Key Metrics

≥90%
Bitterness Suppression
94%
Palatability Acceptance
<100 µm
Pellet Size
2
Layers Applied
36-month shelf life confirmed

Moisture-sensitive API protection

Procurement lead — mid-cap pharma house · Hygroscopic peptide — moisture-labile

Moisture BarrierPeptide

Challenge

Peptide API degraded to below 95% assay within six months under ICH Zone IVb conditions (30°C/65% RH). Existing packaging upgrade alone was insufficient. Product required coating intervention to extend shelf life to 36 months for tropical market registration.

Solution

Coat engineered a three-component moisture barrier: ethylcellulose base coat, PVDC mid-layer, and opadry clear topcoat. Water vapor transmission rate tested at 0.8 g/m²/day. ICH accelerated stability initiated at 40°C/75% RH. 6-month accelerated data equivalent to 24-month real-time projection.

Result

36-month shelf life confirmed at Month 12 real-time. Tropical market dossier submitted to three national authorities. Zero degradation-related impurities above specification threshold.

Key Metrics

36 months
Shelf Life Achieved
0.8 g/m²/day
WVTR
I–IVb
ICH Zones
3
Coating Layers
Primary Path

Request a Coating Feasibility Review

Our scientists review your compound profile and return a written feasibility assessment within 48 hours. No commitment required.

48-hour response · No commitment · NDA available on request

Free Download
Coating Decision Matrix

A structured framework for matching coating platform, polymer system, and process parameters to your compound's physicochemical profile and release target. Used internally by our formulation team on every new engagement.

Platform selection guide
Polymer compatibility matrix
Dissolution target mapping
Scale-up risk checklist

Why teams choose Coat

Feasibility assessment turnaround48 hrs
Consecutive clean FDA inspections11
ANDAs supported to filing47+
Client audit first-pass rate100%