Original Innovative
Pharmaceutical Technology

Striving for a world in which"Good medicine tastes ‘better’ to the mouth."Making generics easier to take, easier to handle, and more accessible.

Sawai Pharmaceutical aims for a future in which "Good medicine tastes better to the mouth"
becomes a matter of course through its innovative pharmaceutical technology.

SAWAI HARMOTECH ® offers six different
technologies to enhance drugs.
Technology that makes it easier to swallow medicine andmakes medicine more portable, easier to handle, and easier to store...

SAWAI HARMOTECH® is a term for Sawai Pharmaceutical's original innovative pharmaceutical technologythat adds value to generic drugs and harmonizes pharmaceutical formulations.

MALCORE®

QALCORE®
Drug-loadedcore particles“Dry-coating” technology for the
manufacture of drug-loaded core particles“Wet-coating” technology for the
manufacture of drug-loaded core particles

DRACORE®

SARAMEL®

Drug-loaded core particles can be preparedby heating without any solvents!

DrySpherical Silica

Drug-loaded core particles can be preparedby using a gelatin-like core with a small amount of water!

Intensity

Humidity
resistanceDisintegration

DRACORE“Adsorption” technology for themanufacture of drug-loaded core particles“Rapidly dissolving” premix excipientsDrug-loaded core particles can be preparedby adsorption of the drug solution into porous carriers!

SARAMEL®, Sawai’s original mixture of four excipientsprovides tablets with “strength,”“moisture-resistance” and “immediate disintegration”!

THRUCOAT®

SARACOAT®

Water

Thin gel layer

Film-coating technology for“smoothly swallowable” dosage form
The coated ﬁlm on surface of tablet will become gelatinousby contact with water
allowing for smooth swallowing with less force.

OD tablets

LightCoating with
Excellent lightresistancea rapidly-soluble ﬁlm

Rapidly dissolving

Film-coating technology fororally disintegrating (OD) tablets

The technology not only makes tablets photo-resistant,but also rapidly dissolvable!
Film-coating technology is now applicable to OD tablets!

Featured TechnologyQALCORE®

“Wet-coating” technology

Pursuit of reduction of oral tablet
and more stable supply.

As a conventional drug-layering technology, commercially available granule cores are coated with a drugsuspension to manufacture drug-loaded particles. Due to the limited size of the commercially available

particle cores, smaller granule cores cannot be manufactured with conventional technology making thecoated granule cores larger in size. In addition, a substantial amount of time is required for the uniform

coating of drug particles, resulting in poor production eﬃciency. Sawai has established an agitating
granulation technology in which the mixture of drug and sticky “gelatin-like core particles (partlypregelatinized starch),” which are smaller in diameter than the general granule cores, are sprayed withwater. The surface of the resulting drug-loaded cores can be coated by a functional ingredient such as apH-dependent or pH-independent polymer in order to mask any undesirable taste including bitterness.

Conventional technology

SAWAI HARMOTECH®

QALCORE®

Massive amount ofdrug suspension

Commerciallyavailable
granule coregelatin-likecore particles

Coating by spraying
the drug suspension

Tumbling fluidized bed

spraymix

Drug-loaded
core particles

drug

Small
amountof water

Drug-loaded
core particles
Centrifugal stirring

Coating time required to manufacture 50% of the drug-loaded core particles

A few hours to a few days

Commercially available
granule core
Functional coating layer

Drug-loaded rate: Low

30 mins to 1 hour

SmallerDrug-loaded Layer

Functional coating layer(bitter-masking andextended-release)gelatin-like core particles

Drug-loaded rate: HighBecause this technology enables the manufacture of highly drug-loaded particles, the number of particles
required per tablet is reduced, leading to a reduction of the tablet size. Additionally, the drug products

containing highly drug-loaded particles are smaller in diameter and feel smoother in the mouth, resulting inimproved mouthfeel. Furthermore, the reduced coating time improves production eﬃciency, resulting in acontribution to a stable supply.

※Patent : Jpn. Unexamined Patent Publication 2021-130618 (foreign application or registration submitted)

Featured TechnologySARAMEL®

“Rapidly dissolving”premix excipients

Pursuit of developmentof high quality drug products.

Tablets, especially orally disintegrating (OD) tablets, are required to (1) be strong enough to withstand handlingduring the distribution process, (2) disintegrate with a small amount of water when orally taken and (3) be moistureresistant (preventing tablet damage due to deterioration of tablet hardness and tablet swelling from moisture). A drug

product is therefore expected to possess these contradictory properties in a well-balanced manner. Although thedevelopment of the OD tablet requires meeting this expectation, it can be diﬃcult to achieve. Sawai has addressed

these speciﬁc challenges and developed an original premix formulation of excipients (SARAMEL®) with the properties
required for OD tablets. SARAMEL®, comprised of commonly used excipients, can be used in various formulations,facilitating eﬃcient development and high-quality drug products.
Easy to handle!

SARAMEL® will be given to tablets highly
strength and moisture-resistant property
and thus improves the handling ability ofthe tablets.

With Sawai’s
conventional
technology

High manufacturing efficiency
SARAMEL® improves the tablet manufacturing
efficiency and thus contributes to a stablesupply.

Featured Technology

Disintegration

xMi

DrugIntensity

asypesy-Eahumidity
resistanceDifficult to manufacture conventional
tablets that possess “strength,”“moisture-resistance” and“immediate disintegration” properties
in well-balanced combination.

Applicable to various drugs!

SARAMEL®, comprised of common excipients,
can be applied to various drugs and isbeing extensively used in many products.

Intensity

ELAM
SAR

Formability on
compression

Disintegration

Humidity
resistance※Patent : Pat. No. 6606287 (foreign application or registration submitted) and Pat. No. 6651638 (foreign application or registration submitted)

THRUCOAT®

“Film-coating” technology

Pursuit of improved ease of oral intake.

As insoluble or poorly absorbable drugs have been increasingly developed in recent years, many newly developed
products are comprised of a large amount of drug substance. Consequently, the tablets developed are large in size.
Additionally, if the drug substance load is reduced to make a miniaturized tablet and improve the ease of oral intake,more tablets have to be taken orally per dose, potentially leading to poor patient adherence. To achieve easy
swallowing of a large tablet or multiple tablets, Sawai has developed a new tablet-coating technology by using aparticular polymer and gelatinizing agent. Regarding the ﬁlm-coating technology (THRUCOAT®), a gelatinous layer will
be formed on the surface when the coating comes in contact with the water used for oral intake, reducing theresistance when passing through the throat. The tablets coated with a mixture of a particular polymer and gelatinizing
agent in a speciﬁc ratio are designed to release the drug after swallowing.

Easy to swallow multiple tablets!

Sawai’s invention also helps patientsswallow multiple tablets.

Some people
may have difficulty inswallowing a large tablet
or multiple tablets.

Water

Thin gel layer

thooSmEasy to swallow a large tablet!

The gelatinous coating film helps patientsswallow a large tablet.

Applicable to various drugs!

Highly versatile formulation that will beapplied to various drugs.

※Patent : World Patent Publication WO2020/179736 (foreign application or registration submitted)