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Emerging Trends of HPMC Capsules in

Prescription Pharmaceuticals.

CPHI - Frankfurt

ACG Capsules : Global Footprint

Subsidiaries: Argentina, Bangladesh, Brazil, Canada, China, Croatia, Indonesia, Thailand, UAE, UK,

USA

Manufacturing: Brazil*, Europe, India

Global Head Office: India

Warehouses: Argentina, Brazil, Europe, Indonesia, Thailand, USA

*Manufacturing plant under construction

Co. Sales Manager: Colombia, Germany, France, Spain

Content

• Introduction: Capsules vs tablets

• Capsules types

• HPMC capsules

• Future

4

Capsules vs Tablets

5

New Chemical Entities

Approved by EMEA & FDA

6

0

5

10

15

20

25

30

35

40

45

50

"Tablets "Capsules "Injection "Others

2007

2015

TOP 10 DRUGS LAUNCHES OF 2017NAME COMPANY DISEASE 2022 SALES

ESTIMATE

(billions$)

DOSAGE FORM

Ocrevus Roche Multiple sclerosis 4,1 Injection

Dupixent Sanofi Atopic dermatitis 4,1

Semuglutide Novo Nordisk Diabetes 2,2 Injection

Durvalumab Astra Cancer 1,9 Injection

Niraparib Tesaro Cancer 1,9 Capsules

Baricitinib Lilly Arhtritis 1,8 Capsules

LEE011 Novartis Breast cancer 1,6 Tablets

KTE-C19 Kitepharma Non- Hodkins

Limphoma

1,4 Injection

Ingrezza Neurocrine Dyskinesia 1,3 Capsules

Spinraza Biogen Muscular atrophy 1,3 Injection

Capsule Types

8

TYPES

Gelatin

GelatinPEG

HPMC

9

PROPERTIES

10

GELATIN

Ezeefit

GELATIN-PEG

Ezeefit

HPMC

Naturecaps

ORIGIN ANIMAL ANIMAL VEGETABLE

STRUCTURE PROTEIN PROTEIN CELLULOSE

MOISTURE

CONTENT (%)

13-16 10-12 3-8

BRITTLENESS AT

LOW RH

Yes Medium Very low

CROSSLINKING Yes Yes No

HPMC Capsules

11

HPMC Capsule Types

• With gelling agent (Naturecaps)

• Without gelling agent (Naturecaps Plus)

12

NATURECAPS

• HPMC POLYMER

• GELLING AGENT

• GELLING PROMOTER

13

50-55ºC 50-55ºC

20-25ºC 20-25ºC

NATURECAPS PLUS

14

0

10

20

30

40

50

60

15 20 25 30 35 40 45 50 55 60 65 70 75 80

Viscosity

T(ºC)

HPMC capsules cold vs hot

Cold

Hot

70-80ºC

In vitro test: Naturecaps

15

-20

0

20

40

60

80

100

120

0 5 10 15 20 25 30 35 40 45 50

%

Time (m)

Naturecaps. ph 1,2. Paddle. Paracetamol

HPMC Capsules Dissolution

16

0

20

40

60

80

100

120

0 5 10 15 20 25 30 35 40 45 50

Nature Caps Supplier A

Advantages

• Low moisture content.

• Better mechanical properties. No brittleness at low RH.

• Lack of crosslinking.

• No chemical interaction with APIs.

Correlation RH / HPMC Capsule Moisture Content

18

y = 0.7832e0.0367x

R² = 0.974

0

2

4

6

8

10

12

14

16

0 10 20 30 40 50 60 70 80 90

Capsule

mois

ture

conte

nt(

%)

RH(%)

HPMC capsule moisture content vs Relative humidity

HPMC Capsules for Inhalation (Ezeeflo)

19

From Seebri Neohaler guide

Source “Powder Capsule and Device”. Aurelie Schouben et al. IJP 2015

Capsule puncturing (1/2)

Capsule puncturing (2/2)

Source “Pierce and Inhale”. F. Martinelli et

Capsule spinning

• At 60 l/m the capsule’s

angular velocity can reach

2800 rpm

• The low moment of inertia

of the capsule makes

possible such high values

• The forces generated at

this rotation deagglomerate

the mixture

Computational Fluid Dynamic

23

From “Use of computational modelling” Zhou et al University of

Sidney

Liquid Filling

24

PAST PRESENT

THE PROBLEM

25

Capsule for

liquid filling

26

COMPATIBILITY

27

28

Future

29

Global HPMC Capsule Sales

(by volume in billions)

30

0

10

20

30

40

50

60

70

80

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Wide Range of Capsules

EZEEFITTM

Empty hard gelatin

capsule

NATURECAP

STM Empty hard

Cellulose (HPMC)

capsule

FLOFITTM

Empty hard capsule

for filling liquids

EZEEFLOTM

Empty hard capsule

for Dry Powder

Inhalation

MARINECAPS®

Empty hard fish gelatin

capsule

CLINICAPS®Capsule for double

blind clinical trial

PEARLZTM

Capsule with shiny

pearl-like finish

BRANDSHIELDTM

Pre-printed empty

hard capsule

Explore What Can We Achieve

Together

We believe that our responsibility does not end by supplying the capsules as per

specifications, it begins there. With strive to add tangible value to our

strategic key customers and create a win-win partnership with them

ACG - Values

VALUES WE LIVE.. VALUES THAT MAKES US ACG..

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