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Discover the endless opportunities thistechnology can offer to your Brand.

Copyright by Procaps S.A. 2021. WWW.SOFTIGEL.COM

SoftgelConsumer PreferenceFACTS & INSIGHTS

Copyright by Procaps S.A. 2021.

Overview:

Straus, Mike. Advances in softgels, capsules, and tablets are keeping these formats at the forefront

of the Industry. Nutritional Outlook. Nov 2018.

Lisa Schofield. Softgels’ Clear Advantages. Natural Products Insider. 2019


The softgel capsule has a strong recognition in the

supplement and the prescription market,

facilitating patient adherence to the drug by

facilitating swallowing thanks to the texture of its

shell.

The softgel capsule has been on the market

since the 19th century evolving to the present

day. Because of this consumers feel familiar with

the technology, trusting its efficiency, quality and

convenience.

The Softgel Capsule:A Superior Delivery System

System with wide-ranging applications

The Softgel Capsule is a solid dosage form composed of two gelatin films that contain semisolid or liquid APIs

protected by an external, hermetically sealed cover.

Softgels ensure high precision dosage by achieving homogeneity of ingredients.

An effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS class II, III and IV(1))


1 BCS Class II – low solubility / high permeability.

BCS Class III – high solubility / low permeability.

BCS Class IV – low solubility / low permeability. Mattson Jack

2 Group survey to 300 consumers in 1999, Softgel capsules market

análisis & trends applications (October 2016)

Key SGC characteristics

Main SGC applications

Enhanced bioavailability of active ingredients

Attractive physical appearance

Greater Stability

Extended Shelf Life

Masks unpleasant odors and flavors

Consumer Preferred Dosage Form/ Easy to swallow

Variety of Shapes, Colors and Sizes

Nutritional: Supplements, vitamins, concentrates and other natural products

Pharmaceutical: Products for any type of indication (OTC and Rx)

Cosmeceuticals: Cosmetic products that have medicinal properties


Impossible to Counterfeit

Softgels, a format that has continuously reinvented itself The softgel capsule responds to vegetarian consumer’s

demands. Cultural, religious, or personal preference reasons lead consumers to follow different free from diets.

Soft capsules made with non animal sources are available to satisfy consumers’ needs.

Softgels deliver the benefits of the formulation without unpleasant experience due to the enteric coats reducing

lingering aftertaste and reflux caused by some active

ingredients.

Compliance increases with fewer doses and fixed dose combination technology in Softgels is ideal to respond to

this. Non-adherence to a treatment is one of the

consequences of swallowing difficulties. Softgel capsules offer chewable options for consumers


Consumer Perceptions &Market ImpactRelative to other Oral Dosage Forms


Studies support that softgels are indeed consumers’ preferred dosage form.SOFTGELS

Since 1999 till today studies have continuously shown that:

Consumers consider SoftgelCapsules as highly desirable:

90%

82%

89%

Of Consumers prefer clear

softgels because they are

“easier to swallow” than other

hard dosage forms.

Consider softgel capsules as

”fast and effective action“**

Report that are easier to

digest**

Are willing to pay more

for products in softgel

form.

25%

*In 1999, the Mattson Jack Group polled approximately 300 consumers in six statescomparing preference of softgels versus other delivery forms.**Lisa Schofield. Softgels’ Clear Advantages. Natural Products Insider. 2019


Consumers’ Preferred Dosage FormSOFTGELS

Softgel Capsules

Tablets

Chewable/Gummy

Hard-Shell Capsules

Sprays/ Inhales

Lozenges/Sublinguals

Powders/Effervescent

Liquids/Tonics/Bever

Source: Nutrition Bussiness Journal survey of 11,435 consumers conducted between 3/27/2014 and

4/8/2014 Source: GELITA Symposium: September 2014”

Least Favorite Most Favorite

“Please rank your preference for how to take your supplements from most liked to least

liked.”


PreferencesCONSUMER

Table 3. Top five dosage forms by indication

Table 2. Dosage forms - Perceptions and preferences

Appears Easier to Swallow

Dosage FormAppears Longer Lasting

Second Choice

Appears to Act

Rapidly

First Choice

Last Choice

Headache

Dosage Form Chronic Pain

Cold/Flu Allergy Antacid VitaminLaxative

*Consumers could name more than one dosage form.

89Clear oval softgel

42Clear oblong softgel

23Gelatin-coated round tablet

19Two-piece, har-shell capsule

18Opaque oblong softgel

8Oblong compressed tablet

7Clear oval softgel

7Gelatin-coated oblong Tablet

72 10 10 2

67 30 40 10

7 11 14 7

33 41 13 9

16 21 7 8

6 21 6 13

11 19 4 39

3 25 5 12

89

78

78

59

59

71

68

67

60

60

77

76

73

55

54

63

62

59

52

49

69

65

64

15

45

52

45

45

38

39

71

67

65

16

47

10

30

11

41

21

21

19

25

Clear softgel

Geltab

Opaque softgel

Two-piece, har-shell capsule

Compressed tablet


PreferencesCONSUMER

The survey confirms

preferences for particular dosage

forms and for softgels over other

dosage forms.

Overall preference was driven by

ease of swallowing, and

softgels were rated first by the

majority of respondents.

Consumers would be interested in various

products if these were available as

softgels rather than in their current oral dosage forms and

maybe willing to pay a premium for

softgel products.

Pharmaceutical scientists and

marketers should consider softgels as alternative dosage

forms when developing new compounds or considering life-

cycle management of existing products.


SOFTGELSSensory Elements

Is Odor a determining factor when choosing a medicine?

Bad smell in a medicine has its

negative consequences in the

experience of consumption and

patient treatment.

Medicines that smell bad

are considered unpleasant.

It is associated with “bad conditions”.

Considered inefective.

Gelatin does not have any odor or flavor, masking any unpleasant smells.


http://www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf

*BMI RESEARCH. Colombia. Pharmaceuticals & healthcare report Q42016. Page 9. Page 45.

** http://psi-inc.org/spanish/counterfeitSituation.cfm

According to data

provided to the WHO

Impact project, 30-40% of

medicines in Latin

America are counterfeit.*

PSI (Pharmacutica Security

Institute) estimates that the

trend in the number of

counterfeiting incidents has

been systematically

increasing year by year

from 2011 to 2015. **

PSI placed Colombia

among the top 10

countries worldwide for

fake and counterfeit.**

Counterfeiting processes,

cannot have high-tech

processes.

This phenomenon, added

to the smuggling of

medicine distributed

throughout Colombia,

becomes a public health

problem and a threat to

the country’s pharma

sector. Drug trading

in the last 10

years.

SOFTGELManufacturing

SafetySoftgels are an example of a

pharmaceutical form where

counterfeiting is not feasible,

providing greater

confidence and security to

consumers.


Light softgels / tablets transit faster than those of thesame size but heavier.

The FDA issued recommendations forgeneric manufacturers establishing

guidelines for improving the intake oforal solids.

Of those who have difficulty swallowing: -15% speak to to their doctors; 8% admits skipping a dose; 4% quits therapy.

Those who have difficulty swallowing blame the

overall size of the tablet.

The use of outer gelatin layers help when swallowing the tablet.

https://www.fda.gov/downloads/drugs/guidances/ucm377938.pdf

SOFTGELSSensory Elements

Is Size a determining factor when choosing a medicine?



The Evolutionof Great Brands

Toward Softgel Formats


Innovationthrough Product Portfolio

EXPANSION

SoftgelDerivations


Enteric Coated softgels are the best way to stabilize acid-

sensitive drug products. This is because the API is not delivered

in the stomach and instead targets drug delivery in the small

intestine, which is preferred to treat intestinal disease,

improving tolerance and reducing afteraste,

Resists absorption in the stomach.

KEY ENTERIC COATED SOFTGELS CHARACTERISTICS:

Improves Patient acceptance – Avoidingreflux in pregnant women.

Masks unpleasant odors and flavors.

Chemical Stability: Oxygen and moistureprotection barrier that prevents Omega acidoxidation and Oxidation/Hydrolysis of thevitamins.


Double coated for Better appereance.

Enteric-Clear Softgels use the Enteric-Coated Softgel method of

stabilizing acid-sensitive drugs, but it has a patient-appealing

aesthetic.

Consumers often prefer clear capsules over opaqie and this design

also means fewer steps in the development process, as no coating

is necessary.

KEY ENTERIC CLEAR SOFTGELS CHARACTERISTICS:

Greater Bioavailability

Rapid Apsorption

No fish aftertasre

Less irritation of digestive orpastric mucosa, due to itsapsorption at the intestinal level.

Exact Dosing

Physiscally Appealing

Impossible to Counterfeit

Life-Cycle Management Extension.


As the leading Manufacturer of Softgel-Related

technologies, softgel offers unparalleled custom capsule

services. Design your very own Stripgels.

KEY STRIPGELS ADVANTAGES:

Physically Appealing

Completely Customizable

Brand Identification

New Customer Experience


With

Reducegels,

receive full

strength and

power in

a smaller softgel

size.

KEY REUCEGELS ADVANTAGES:

Enables higher API concentrations in

smaller softgel

A solution for complex API formulations

A Capable of delivering single and

combination API formulations

Tamper-evident

KEY REDUCEGELS Consumer Benefits:

Ideal for Seniors and Children

Available in a variety of Colors, Shapes,

Sizes and Clarity

Suitable for Vegetarians


A soft gelatin capsule with twist-o cap allows access to a

measured dose for topical and/or oral applications.

KEY TWISTELS ADVANTAGES:

Better Dosage Accuracy

Eliminates Contamination by repeat use

Improves Compliance

Improved Stability

KEY TWISTELS CONSUMER BENEFITS:

Portable On-The-Go

Easy to twist- Ideal for geriatric, pediatric

and veterinary use

Available in variety of Colors, Shapes,

Sizes and Clarity

No water needed


A The softgel vaginal ovule or insert, Vaogels, was

designed mucoadhesive properties ti facilitate retention ofthe product in the vagina and availability of the active

ingredient in a site-specific manner.

KEY VAOGELS ADVANTAGES:

Conical shape for easy application

Softgel hydrophilic outer layer

Improves treatment efficiency

Greater Dissolution/Faster disintegration

Exact Dosage

Lipophilic Exipients for better vaginal adherence and efficacy

Gentle and Non-Irritating

Stable until Inserted


UNIGELTM

Fixed dose combination in

softgels for Multi-dose therapies

G-TABSTM

Masking unpleasant tastes

and odors with our gelatin

coated tablets

VERSAGELTM

Versatile softgel

Technology free from

Animal Derivatives

FUNTRITIONTM

Delivering easy nutrition with a

variety of formulations in

Nutritional Gummies

CHEWGELSTM

Chewable softgels as a

new solution for kids

and consumers who

have difficulty

swallowing.

Propietary Innovative

Softgel TechnologiesFOR EVERY PATIENT/CONSUMER NEED:


• “Damian, F.; Harati, M.; Schwartzenhauer, J.; Van Cauwenberghe, O.;Wettig, S.D. Challenges of Dissolution Methods Development for Soft Gelatin Capsules. Pharmaceutics 2021, 13, 214. https://doi.org/10.3390 Pharmaceutics13020214

• Straus, Mike. Advances in softgels, capsules, and tablets are keeping these formats at the forefront of the industry. Nutritional Outlook. Nov 2018.

• Source: Kaspar van den Dries. Debunking Myths And Misconceptions About Softgels. Pharmaceutical Online. 2020.

• Lisa Schofield. Softgels’ Clear Advantages. Natural Products Insider. 2019

Sources:


For more information on our diverse technology

portfolio visit:

WWW.SOFTIGEL.COMOr email us at: [email protected]


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