Note Jpn J Pharm Health Care Sci

45(5) 292―299 (2019)

Comparison of the Glimepiride Brand Name Medication and

Generic Medications in the Simple Suspension Method and
Their Dissolution Behavior
Chieko Maida , Etsuko Miyamoto , Yuka Sugita ,
＊1 2 1

Kohta Nakayama , Yoshifumi Murata and Shigeo Akiyama

1 1 3

Faculty of Pharmaceutical Sciences, Hokuriku University＊1,

Acanthus Pharmacy, Nonprofit Organization Health & Welfare・Eco-Protect・area Contribution・
Refresh Education・Town Communication 2,
Center for Experiential Pharmacy Practice, Tokyo University of Pharmacy and Life Sciences 3

Received December 10, 2018

Accepted March 19, 2019

 As many generic medications, including orally disintegrating (OD) tablets, are now commercially available, including
glimepiride, the third-generation sulfonylurea drug, it is important to provide information regarding their formulation
for adequate medical care. In this study, we conducted a tube passing test and a recovery rate measurement in order to
investigate the applicability of a simple suspension method recommended for medication support of glimepiride (JP
XVII), which includes the brand name glimepiride (Amaryl®) and 27 generic medications. In addition, a dissolution test
for each drug was conducted with comparisons between formulations. The results showed that five companies generic
medications required an additional five minutes suspension time and one company s tablet needed to be cracked with
pliers in advance to facilitate the simple suspension method. After the tube passage test, no significant difference was
found in any of the generic medications in comparison with the brand name medication in terms of the recovery rate of
a drug containing glimepiride. The dissolution behavior showed that generic medications for three companies did not
comply with the dissolution requirements. This result shows that the brand name medication and all generic medications
are available for use according to the simple suspension method. However, because these medications had different
disintegration and suspension times, it is necessary to confirm the disintegration and suspension properties of each
medication. This information should be described in the Drug Interview Form or the like.

 Key words ―― glimepiride, brand name medication, generic medication, simple suspension method,
tube administration, dissolution behavior

Introduction pared with the same survey of 2012. Although the

According to the National Health and Nutrition
Survey conducted by Japan s Ministry of Health,
Labour and Welfare in 2016, people who are
strongly suspected of being diabetic or actually
suffer from diabetes number about 10 million;
those who cannot deny the possibility of diabetes
(diabetes preliminary group) are of an equal num-
ber. It was estimated that people suffering from
diabetes had increased by about 500,000 com-
diabetes preliminary group has decreased by
about 1 million, it still remains that diabetic pa-
tients, including the diabetes preliminary group
numbers near 20 million. It follows that diabetes
remedy drugs with various action mechanisms
1)
will continue to be used in the future.
According to a survey carried out in 2010 by
the All Japan Hospital Association and with the
cooperation of nursing care and housing facilities,
approximately 260,000 patients nationwide have

＊
Ho-3, Kanagawa-machi, Kanazawa-shi, Ishikawa 920-1181, Japan

292

or will have food and medicines introduced
2)
through gastrostomy. Previously administered
with pulverized preparations before the introduc-
tion of tube administration in 2013, according to
a survey by the Japanese Society of Hospital
Pharmacists of 753 facilities approximately 80％
of them have implemented the simple suspension
3)
method.
Tube administration employing the simple sus-
pension method now predominates in hospitals
and care facilities. In the simple suspension method
tablets and capsules disintegrate and become sus-
pended in warm water at about 55℃ permitting
gavage feeding, a method using tubes, to be
4, 5)
administered to many patients.
Concurrent with Japan s aging society, drug
therapy at the time of administration of tube
6)
feeding is being studied in diabetic patients.
While the use of sulfonylurea drugs is on a down-
ward trend, the generic third generation of
7)
glimepiride (JPXVII ) can be administered either
before or after meals and, as hypoglycemia is
unlikely to occur, many generic drugs, including
OD tablets, are now marketed. Also approved as a
combination drug with pioglitazone in 2011,
glimepiride will continue to be used into the
future.
Simple suspension method – handbook for
tube administration of oral medicines , 3rd edi-
5)
tion (Handbook) was released in March, 2015.
Much information, especially regarding generic
medications was not covered and, without such
information, administration procedures will be
determined by individual facilities. In the case of
preparations containing glimepiride, an oral dia-
betic drug sold by 30 companies as of April 2017,
only 21 items are listed in the Handbook.
Therefore, in this study, glimepiride including
Amaryl® and 27 generic glimepiride medications
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Vol 45，No 5（2019）
were evaluated regarding administration with the
simple suspension method in order to determine
tube passage and to compare and examine the
amount of drug actually entering the patient s
body; the recovery rate of the glimepiride after
passing through the tube was also measured. In
addition, from the viewpoint of a quality evalua-
tion of solid preparations for oral administration,
a dissolution test was conducted and evaluated.
Materials and Methods
1. Samples
Test formulation: all tablets (glimepiride 1 mg)
used in the experiments were purchased from the
28 companies involved (Table 1). Amaryl is a
brand name medication while No s 1 to 27 are ge-
neric medications. Table 1 shows the pharmaceu-
tical excipients of each formulation.
2. Reagents
All the solvents used in the experiment were
special grade reagents used after filtration (0.45
μm) and degassed if necessary. Glimepiride (LKT
Laboratories, Inc, St Paul, Minnesota, USA) was
purchased as the standard product for the experi-
ment.
3. Simple suspension method
Kurata s method was used for the simple sus-
pension method. To a capped syringe was added 1
tablet to be tested and 20 mL of warm water at
55℃ then left for 5 minutes. The state of disinte-
gration of the tablet after 5 minutes was observed
and, when it was not sufficiently disintegrated
was again observed after shaking the syringe
quickly (180°inversion, 15 times). The suspended
solution was injected into the injection port of the
feeding tube (EVA enteral nutrition catheter,
Jpn J Pharm Health Care Sci

Table 1　List of Glimepiride 1 mg Tablets tested and their pharmaceutical excipients

Generic madications
Excipient Amaryl
2, 9 3, 6, 22 4 5 12 18 21 25 26 27
Lactose 〇 〇 〇 〇 〇
D-Mannitol 〇 〇 〇 〇 〇 〇
Light Anhydrous Silicic
Acid 〇
Microcrystalline cellulose 〇 〇 〇 〇 〇 〇 〇 〇
Povidone 〇 〇 〇 〇 〇 〇
Sodium Starch Glycolate 〇 〇 〇 〇 〇 〇 〇 〇
Hydroxypropylcellulose 〇 〇 〇
Low Substituted
Hydroxypropylcellulose 〇 〇 〇
Crospovidone 〇 〇 〇 〇
Magnesium Stearate 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇
Sodium Stearyl Fumarate 〇
Red Ferric Oxide 〇 〇 〇 〇 〇 〇 〇 〇 〇 〇
Partially Hydrolized
Polyvinyl Alcohol 〇 〇 〇
Polyoxyl 40 Stearate 〇 〇
Partly Pregelatinized
Starch 〇 〇
Sodium Lauryl Sulfate 〇
Citric Acid 〇
Excipients similar to the Amaryl: No＇s 1, 7, 8, 10, 11, 13, 14, 15, 16, 17, 19, 20, 23, 24.

NIPRO Co, Osaka, Japan) at a rate of about 2-3
mL/sec. After injecting the suspension, the syringe
and feeding tubes were washed with 10 mL of
warm water to quantify any remaining amount.
The suspension solution was judged to have
passed without problem through the feeding tube
when no particles remained in the syringe or tube.
If the tablet did not disintegrate after shaking, the
syringe was left for another 5 minutes and again
shaken and observed. For the one preparation
which did not disintegrate within 10 minutes, the
same operation and evaluation was carried out
after cracking a new tablet.
4. Dissolution behavior
The test was carried out according to the
Japanese Pharmacopoeia general test method /
dissolution test method 2 (paddle method). The
temperature of the test solution was maintained
at 37 ± 0.5℃, with 900 mL of sodium dihydrogen
phosphate · citrate buffer solution (0.05 mM) at
pH 7.5 used as the test solution. The paddle rota-
tion speed was 50 rpm and sampling time was at
0, 5, 15 and 30 minutes. In addition, tablet disso-
lution test disintegration times were visually con-
firmed.
5. Determination of glimepiride concen-
tration7)
Reverse phase partitioning high performance
liquid chromatography (HPLC) was used for the
quantification of glimepiride. The equipment used
for HPLC is as following:
Sample introduction device: TOSOH AS-8020
(Tosoh Co, Tokyo, Japan), liquid transfer unit:
L I QU I D C H RO M ATO G R A P H L C - 1 0 AT
(Shimadzu Co, Kyoto, Japan), detector: UV-VIS
DETECTOR SPD- 10 A (Shimadzu Co), System
controller: LC-8020 model II (Tosoh Co).
The mobile phase was (0.1％ NaH2PO4 / aceto-
nitrile = 1 / 1; the pH was adjusted to 3.5 with di-
luted phosphoric acid (1→5)) and was monitored

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at 228 nm at a flow rate 1.1 mL/min. The concen- Results

tration of the drug in the sample was estimated
from the calibration curve prepared at the same
time. A calibration curve measured using the peak
area showed a good linear relationship at the con-
centration range from 0.275 to 1.1 μg/mL.
6. Measurement of tablet hardness
Hardness was measured sampling 10 tablets
using a hardness measuring machine, PC-30
(Okada Seiko Co, Ltd, Tokyo, Japan).
1. Simple suspension method and cathe-
ter passage test
The results of the simple suspension method of
the test formulations are shown in Table 2. Twenty
two out of 28 companies tablets, including the
brand name medication, disintegrated and sus-
pended within 5 minutes. However, there was one
tablet that required cracking prior to suspension
and five tablets exhibiting longer times for disinte-
gration and suspension. 5 out of 6 generic products
(No s 3, 19, 20, 22 and 24) only disintegrated
and suspended within10 minutes; the remaining

Table 2　Assessment of Simple Suspension Method for Glimepiride Tablets

Cracking with Assessment Final Recovery of
Hot water Assessment of Tablet hardness
pliers → Hot for passage assessment glimepiride
Test (55℃) disintegration (kg)
water (55℃) through a for the simple (％)
product and suspension (Mean ± SD)
feeding tube suspension (Mean ± SD)
5 min 10 min 5 min 10 min (n = 6) (n = 10)
(n = 6) method ＊ (n = 3)
Amaryl ○ ― ○ ○ 1 99.8 ± 4.4 4.6 ± 0.2
No 1 ○ ― ○ ○ 1 101.3 ± 6.2 3.4 ± 0.4
No 2 ○ ― ○ ○ 1 105.5 ± 3.1 3.5 ± 0.2
No 3 △ ○ ○ ○ 1 102.2 ± 2.9 5.7 ± 0.2
No 4 ○ ― ○ ○ 1 99.4 ± 3.0 6.4 ± 0.1
No 5 ○ ― ○ ○ 1 99.8 ± 0.2 3.8 ± 0.3
No 6 × × × ○ ○ ○ 2 98.7 ± 3.0† 5.5 ± 0.8
No 7 ○ ― ○ ○ 1 99.1 ± 4.0 6.2 ± 0.5
No 8 ○ ― ○ ○ 1 99.7 ± 3.3 5.9 ± 0.3
No 9 ○ ― ○ ○ 1 100.3 ± 1.7 3.6 ± 0.2
No 10 ○ ― ○ ○ 1 95.1 ± 2.6 4.6 ± 0.1
No 11 ○ ― ○ ○ 1 101.1 ± 3.4 4.2 ± 0.3
No 12 ○ ― ○ ○ 1 102.5 ± 6.0 4.1 ± 0.5
No 13 ○ ― ○ ○ 1 100.8 ± 1.1 3.8 ± 0.3
No 14 ○ ― ○ ○ 1 98.5 ± 3.9 6.3 ± 0.7
No 15 ○ ― ○ ○ 1 100.8 ± 2.1 4.9 ± 0.3
No 16 ○ ― ○ ○ 1 97.9 ± 5.8 4.6 ± 0.3
No 17 ○ ― ○ ○ 1 97.2 ± 1.2 5.5 ± 0.5
No 18 ○ ― ○ ○ 1 99.0 ± 3.4 3.3 ± 0.3
No 19 △ ○ ○ ○ 1 99.1 ± 2.2 3.8 ± 0.4
No 20 △ ○ ○ ○ 1 103.8 ± 5.2 4.7 ± 0.3
No 21 ○ ― ○ ○ 1 99.3 ± 2.1 3.9 ± 0.1
No 22 △ ○ ○ ○ 1 97.6 ± 3.4 4.3 ± 0.4
No 23 ○ ― ○ ○ 1 100.0 ± 1.1 5.4 ± 0.3
No 24 △ ○ ○ ○ 1 104.9 ± 5.0 5.8 ± 0.7
No 25 ○ ― ○ ○ 1 101.8 ± 1.7 5.4 ± 0 .2
No 26 ○ ― ○ ○ 1 105.6 ± 6.1 ＊＊
No 27 ○ ― ○ ○ 1 102.9 ± 1.6 ＊＊
＊Final assessment for the simple suspension method. 1: disintegrated and suspended within 10 minutes and passed through feeding tube. 2:
cracking with pliers → disintegrated and suspended within 10 minutes and passed through feeding tube. ＊＊Since it is an elliptical tablet, it was not
measured. † Recovery of glimepiride after cracking with pliers (Not cracking: 93.7 ± 4.6％).

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generic product (No 6) was not completely disin- Table 3　Dissolution average for test products at 15 minutes
Dissolution (％) Dissolution (％)
tegrated within10 min. Accordingly, for No 6, the Test Test
(Mean ± SD) (Mean ± SD)
Product Product
tablet surface was cracked and then tested; all (n = 3) (n = 3)
Amaryl 88.5 ± 1.8 No 14 88.5 ± 6.2
modified No 6 tablets disintegrated and suspended No 1 84.3 ± 1.6 No 15 83.8 ± 5.2
within 10 minutes (n = 6). No 2 81.4 ± 1.5 No 16 83.5 ± 4.0
No 3 72.2 ± 1.4 No 17 86.9 ± 7.3
Regarding disintegration and suspension proper- No 4 81.8 ± 1.3 No 18 82.9 ± 6.4
No 5 82.8 ± 5.9 No 19 88.1 ± 2.9
ties, 1 tablet of 6 tablets of No 6 had not disinte- No 6 70.1 ± 4.7 No 20 91.8 ± 1.6
grated and suspended within 10 minutes when not No 7 87.0 ± 3.2 No 21 85.6 ± 7.4
No 8 83.9 ± 0.7 No 22 78.7 ± 12.5
cracked, while when cracked, 1 tablet in 3 tablets No 9 78.2 ± 3.1 No 23 83.9 ± 0.7
No 10 70.8 ± 3.2 No 24 91.3 ± 2.2
left a residue after flushing. For No 11, 2 tablets
No 11 86.3 ± 1.7 No 25 84.4 ± 3.2
out of 6 tablets took 10 minutes to be disintegrated No 12 76.3 ± 6.6 No 26 79.6 ± 1.2
No 13 87.3 ± 7.2 No 27 90.2 ± 2.6
and form suspension. Only 2 tablets out of 6 tab-
lets in No 19 and No 20 and 1 tablet in 6 tablets
7)
in No 24 disintegrated and reached suspension within the JP 17 standard.
within 5 minutes. With the exception of the five
companies medications (No s 6, 11, 19, 20 and 3. Hardness of tablets
24), all tested tablets disintegrated and suspended The results of the hardness test for the test
uniformly. preparation are shown in Table 2. The average
From the above results the simple suspension hardness of the 26 formulations excluding ellipti-
method can be applied to all test formulations cal tablets (No 26, 27) was 3.3 ± 0.3 to 6.4 ±
examined at this time. With the exception of 0.1 kg. Some medications with low hardness were
company No 6 s product, all companies medica- observed to take longer than 5 minutes to disinte-
tions were judged to be suitable 1 while No 6 grate to suspension.
was suitable 2 .
4. Dissolution behavior
2. Recovery rate of glimepiride The average dissolution rate of each prepara-
Table 2 shows the recovery rate of glimepiride tion for 15 minutes is shown in Table 3. The de-
after passing through the tube. The average scription regarding the glimepiride tablet dissolu-
recovery rate of Amaryl tablets after passing tion test in the Japanese Pharmacopoeia reads:
through the tube was 99.8 ± 4.4％. Meanwhile, the The dissolution rate in 15 minutes of 1 mg tab-
7)
average recovery rate of generic medications was lets is not less than 75％. The generic medica-
95.1 ± 2.6 to 105.6 ± 6.1％, with no significant tions that did not conform to the dissolution
decrease in recovery rate in any of the prepara- requirements were No 3, No 6, and No 10.
tions. No significant difference was observed
between the brand name medication and the
generic medications. The tube passage rate for a
Discussion
non-cracked No 6 tablet was 93.7 ± 4.6％, and Simple suspension method, tube passage test
98.7 ± 3.0％ when cracked. In addition, the and recovery of glimepiride: all 28 formulations
recovery rates of all the test medications were were able to be administered by simple suspen-

296

sion method with no problem with the recovery
rate of the main drug after passing through the
feeding tube. Since the recovery rate of the main
drug was within the Japanese Pharmacopoeia
specified range for all test formulations, it is con-
sidered that there was no adsorption to the tube
either. However, although 22 formulations disin-
tegrated and became suspended within 5 minutes
and passed through the tube, 5 formulations took
10 minutes to disintegrate and reach suspension.
In addition, one company s formulation did not
disintegrate and reach suspension unless the
tablet had been cracked prior to placement in the
syringe. Since the recovery rate of the main drug
after passage through the tube was around 100％,
it is considered that there is no problem of stability
in administration by the simple suspension method.
There were 10 formulations that were not
described in the Handbook of which 7 were not
registered in the simple suspension availability
information sharing system. Accordingly, after
our study, we registered the information of the 7
formulations (No s 3, 4, 6, 12, 21, 22, 25 and 27)
(December 6, 2017).
As described in the Handbook and Data Regis-
tered in the Simple Suspension: Completion In-
formation Sharing System comparing the results
of this time, there were 6 generic medications
with different times necessary to disintegrate and
reach suspension. While the conventional data
shows 10 minutes as needed three out of six com-
panies formulations (No s 11, 12 and 18) took 5
minutes to reach suspension. For the remaining
three companies (No s 3, 6 and 24), the conven-
tional data shows 5 minutes but required 10 min-
utes and No 6 needed to be cracked before the
test. In addition, the result of the simple suspen-
sion method test by No 6 manufacturer was
complete disintegration in 5 minutes. Changes in
297
Vol 45，No 5（2019）
product information and changes to the attached
document were not allowed but it was suggested
that published information, including manufac-
turing time, may not be applicable.
Relation of disintegrating suspension and addi-
tives: there were reports that excipients were in-
8)
volved in the disintegration of the formulation.
Considering the common point of preparations
with prolonged disintegration, the additive in No
19 is the same as that of Amaryl and differences
in disintegration suspension properties could not
be determined as factors. Among the six drugs
with longer disintegration time, there were three
formulations with lactose and D-mannitol as ex-
cipients, though caused factors could not be speci-
fied. However, there were reports that disintegra-
tion time is prolonged due to a high concentration
9)
of the binder. We believe that the type and con-
centration of excipients may affect disintegration.
Hardness and disintegration and suspension of
tablets: regarding the hardness of the tablets
studied, no significant difference was observed
except for two elliptical tablets which were not
measured. Regarding the relation between the
disintegration time of the simple suspension
method and the hardness of the tablet any influ-
ence was thought to be small. Variable tablet
hardness of 3 to 7 kg is considered to be related
to disintegration time. Low hardness tablets (No s
1, 2, 9 and 18) and high hardness tablets (No s 4,
7 and 14) all disintegrated and became suspended
within 5 minutes however. No recognizable rele-
vance was found for disintegration or suspension
time based on tablet hardness. Nor was there a
recognizable relation found with respect to
hardness and dissolution property.
Jpn J Pharm Health Care Sci
Dissolution behavior: in the results of this
study, three of the 27 formulations (No s 3, 6 and
10) did not conform to dissolution requirements.
The Information Package of Quality of Prescrip-
tion Drugs (Blue Book) states that no formulation
in which dissolution behavior at pH 7.5 is a problem
was observed (http://www.nihs.go.jp/drug/ecqa-
ged/bluebook/k/o_Glimepiride_Tab_01.pdf,
December 1, 2018). However, depending on the
pH of the test solution, it is reported that adsorp-
tion of the drug to the membrane filter occurs and
there is a possibility that the filter used at the time
of the dissolution test or quantitative determina-
tion may affect the results. The results showed
that the simple suspension method can be applied
with all products, including preparations that are
not compatible with the dissolution requirements.
Dissolution behavior and ease of disintegration
during simple suspension method: among the for-
mulations of the three companies that did not
comply with the official dissolution test standard,
No 3 took 10 minutes for disintegration and sus-
pension and No. 6 s tablet needed to be cracked.
Also, those with an apparent disintegration end
time exceeding 10 minutes at the time of dissolu-
tion test were No s 3, 6, and 22, and these were
also preparations which took a longer time to dis-
integrate in the simple suspension method. Also,
the types of additives in No s 3, 6 and 22 were the
same, but the amount of each component was not
evaluated.
Generic medications and drug information: ac-
cording to the Ministry of Health, Labour and
Welfare Ministry data issued September 2017, the
number share of generics is 65.8％, with the aim
to increase this share to 80％ by September 2020
(http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/
298
kenkou_iryou/iryou/kouhatu-iyaku/index.html,
December 1, 2018). In addition, the proportion of
the elderly population in the total population of
Japan continues to rise, and is estimated to be
35.3％ in 2040. According to a survey conducted
by the Japan Chronic Medical Association in
2015, alimentary nutrition is being conducted in
about 60％ of medical institutions having nursing
care wards and more than 60％ of patients in both
sanatorium long-term care beds and medical long-
10)
term care beds received such feeding. There is
also a report that swallowing disorder is recog-
11)
nized in 30 to 60％ of elderly people. Considering
these numbers, it is expected that the opportu-
nity to use generic medications will also increase
in the simple suspension method. Information on
the simple suspension method and tube passage
of preparations containing glimepiride according
to our study is considered to be useful as an indi-
cator of generic options for patients receiving
tube administration. As it has been reported that
the simple suspension method and dissolution be-
havior for generics are different from that of the
12, 13)
brand name medication. From the results of
this study, it is obvious that there are cases where
conditions differ between the brand name medi-
cation and generic medications in cases of adminis-
tration by simple suspension method such as by
tube administration. Medical staff, nurses, and
care givers must be made aware of these dif-
ferences with information provided by the pharma-
cists who dispense such preparations that have
different disintegration properties or suspension
times. Clinical pharmacists are required to care-
fully examine the stability and characteristics of
such drugs and make judgements after collecting
information on simple suspensions based on the
physical and chemical properties of the pharma-
ceuticals. In the future, not only for brand name

medications but also generic medications, drug
stability, disintegration suspension ability and
tube passage of drugs related to the simple sus-
pension method should be described in the Drug
Interview Form and the like in addition to updated
information expected to be released on the inter-
net, etc.
Conflict of Interest
There are no conflicts of interest to be disclosed
in the preparation of this paper.
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