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Title:
COMPRESSED TABLET COMPRISING L-THEANINE
Document Type and Number:
WIPO Patent Application WO/2021/219360
Kind Code:
A1
Abstract:
The present invention relates to a new formulation containing L-theanine. The formulation of the present invention is a compressed tablet, which is also a chewing gum.

Inventors:
BARBOSA JOSÉ (CH)
MA ZHENBO (CH)
SALMON CONROY (CH)
SITEMAN SHERRY (CH)
Application Number:
PCT/EP2021/059500
Publication Date:
November 04, 2021
Filing Date:
April 13, 2021
Export Citation:
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Assignee:
DSM IP ASSETS BV (NL)
International Classes:
A61K9/68; A23G4/12; A61K9/20; A61K31/198
Foreign References:
US20120121520A12012-05-17
EP1743634A12007-01-17
Other References:
ANONYMOUS: "Amazon.com: OLLY Sleep Melatonin Gummy, All Natural Flavor and Colors with L Theanine, Chamomile, and Lemon Balm, 3 mg per Serving, 25 Day Supply (50 Count): Health & Personal Care", 15 April 2018 (2018-04-15), XP055822186, Retrieved from the Internet [retrieved on 20210707]
Attorney, Agent or Firm:
KURT, Manfred (CH)
Download PDF:
Claims:
Claims

1. A compressed tablet comprising

(i) 2 - 15 weight- % (wt-%), based on the total weight of the compressed tablet, of L- theanine, and

(ii) up to 5 wt-%, based on the total weight of the compressed tablet, of Chamomile extract, and

(iii) 20 - 90 wt-%, based on the total weight of the compressed tablet, of a gum base, and

(iv) up to 30 wt-%, based on the total weight of the compressed tablet, of at least one

Vitamin (fat and/or water soluble), and

(v) up to 70 wt-%, based on the total weight of the compressed tablet, of any other ingredient (auxiliary compound) usually used in a compressed tablet.

2. Compressed tablet according to claim 1 , wherein the compressed tablet has a total weight of 0.5 - 5 g.

3. Compressed tablet according to claim 1 or claim 2, wherein the compressed tablet comprises 3 - 12 wt-%, based on the total weight of the compressed tablet, of L-theanine.

4. Compressed tablet according to anyone of the preceding claims, wherein the com pressed tablet comprises 0.5 - 3 wt-%, based on the total weight of the compressed tablet, of Chamomile extract.

5. Compressed tablet according to anyone of the preceding claims, wherein the com pressed tablet comprises 55 - 80 wt-%, based on the total weight of the compressed tablet, of a gum base.

6. Compressed tablet according to anyone of the preceding claims, wherein the com pressed tablet comprises at least one water-soluble Vitamin and at least one fat-soluble Vitamin. 7. Compressed tablet according to anyone of the preceding claims, wherein the com pressed tablet comprises at least one water-soluble Vitamin chosen from the group con sisting of Vitamin C and B complex Vitamins and at least one fat-soluble Vitamin chosen from the group consisting of Vitamin E, Vitamin A, Vitamin D3, and Vitamin K.

8. Compressed tablet according to anyone of the preceding claims, wherein the com pressed tablet comprises 0.2 - 6 wt-%, based on the total weight of the compressed tablet, of at least one Vitamin.

9. Compressed tablet according to anyone of the preceding claims, wherein the com pressed tablet comprises 1 - 50 wt-%, based on the total weight of the compressed tablet, of at least one auxiliary compound.

10. Compressed tablet according to anyone of the preceding claims, wherein the at least one auxiliary compound is chosen from the group consisting of sweeteners, flavors, dilutents, and lubricants.

11. Compressed tablet according to anyone of the preceding claims, wherein the com pressed tablet according to the present invention is coated.

12. Compressed tablet according to claim 11 , wherein the coating is a film coating or sugar coating.

Description:
Compressed Tablet Comprising L-Theanine

The present invention relates to a new formulation containing L-theanine. The formulation of the present invention is a compressed tablet, which is also a chewing gum.

The chewing gum of the present invention comprises L-theanine and also optionally some Chamomile extract.

L-Theanine is a unique amino acid found naturally in the tea plant (Camellia sinensis). Among other positive propertied, L-Theanine promotes relaxation while maintaining alert ness and promotes healthy cognitive function. L-Theanine may also support healthy vas cular function through this relaxing effect.

A unique property of L-theanine is that is promotes relaxation without drowsiness.

L-theanine has poor compressibility. To deliver L-theanine in tablet format often faces challenges such as capping and low tablet hardness.

Therefore, many L-theanine tablets have either lower L-theanine claim such as 100 mg and high serving size (2 tablets).

There are also L-theanine capsules commercially available but the 2-piece capsule shell is often relatively large and not very easy for a consumer to swallow.

Another problem of formulations comprising Chamomile extract is that Camomile extract is oily upon compression in a regular tablet formulation. This causes some problems such as sticking.

Due to the great properties of L-theanine, there is always beneficial to provide improved formulation comprising L-theanine. These new and improved formulations do not have the disadvantages of the prior art.

It is surprising that it was possible to compress L-theanine and optionally Chamomile ex tract in a tablet with the aid of gum powder. The tablet was further coated at relatively low temperature to achieve better physical appearance.

The compressed tablet, which is also a chewing gum, has none of the disadvantages. The compressed tablet of the present invention is chewed and while chewing the healthy ingredients (next to L-theanine, other ingredients may also be incorporated into the new formulation) are released in the mouth and the conveyed into the gut system. The tablet is not swallowed and after a certain time (when the healthy ingredients have been re leased) the rest of the tablet (mainly the gum base) can be spit out (like a regular chewing gum).

Therefore, the present invention relates to a novel confectionery, which is a compressed tablet (CT), comprising

(i) 2 - 15 weight-% (wt-%), based on the total weight of the compressed tablet, of L-theanine, and

(ii) up to 5 wt-%, based on the total weight of the compressed tablet, of Chamomile extract, and

(iii) 20 - 90 wt-%, based on the total weight of the compressed tablet, of a gum base, and

(iv) up to 30 wt-%, based on the total weight of the compressed tablet, of at least one Vitamin (fat and/or water soluble), and

(v) up to 70 wt-%, based on the total weight of the compressed tablet, of any other ingredient (auxiliary compound) usually used in a compressed (chewable) tab let.

It is obvious that all the ingredients of a compressed tablet according to the present inven tion are always adding up to 100%.

A suitable compressed tablet has usually a total weight of 0.5 - 5 grams (preferably 1 - 5g).

Therefore, the present invention relates to a compressed tablet (CT1), which is a com pressed tablet (CT), wherein the compressed tablet has a total weight of 0.5 - 5 g.

The shape of the compressed tablets according to the present invention is not so essen tial. It can have usually used shape for tablets (disc-like, cubes, spheres or any other shape). Preferably, the compressed tablet according to the present invention comprises 3- 12 wt- %, based on the total weight of the compressed tablet, of L-theanine.

More preferably, the compressed tablet according to the present invention comprises 4 - 10 wt-%, based on the total weight of the compressed tablet, of L-theanine.

Therefore, the present invention relates to a compressed tablet (CT2), which is a com pressed tablet (CT) or (CT1), wherein the compressed tablet comprises 3 - 12 wt-%, based on the total weight of the compressed tablet, of L-theanine.

Therefore, the present invention relates to a compressed tablet (CT2’), which is a com pressed tablet (CT) or (CT1), wherein the compressed tablet comprises 4 - 10 wt-%, based on the total weight of the compressed tablet, of L-theanine.

Preferably, the compressed tablet according to the present invention comprises 0.5 - 3 wt-%, based on the total weight of the compressed tablet, of Chamomile extract.

More preferably, the compressed tablet according to the present invention comprises 0.8

- 2.5 wt-%, based on the total weight of the compressed tablet, of Chamomile extract.

Therefore, the present invention relates to a compressed tablet (CT3), which is a com pressed tablet (CT), (CT1), (CT2) or (CT2’), wherein the compressed tablet comprises 0.5

- 3 wt-%, based on the total weight of the compressed tablet, of Chamomile extract.

Therefore, the present invention relates to a compressed tablet (CT3’), which is a com pressed tablet (CT), (CT1), (CT2) or (CT2’), wherein the compressed tablet comprises 0.8

- 2.5 wt-%, based on the total weight of the compressed tablet, of Chamomile extract.

The compressed tablet is a chewing gum, therefore an essential ingredient of the com pressed tablet according to the present invention is a gum base. Such a gum base is well known ingredient in commonly known chewing gums. Such gum bases are commercially available. Usually, formulations of gum bases are considered proprietary information for industry competitors. But usually three main components make up all gum bases: resin, wax, and elastomer. Resin (ex. terpene) is the main chewable portion. Wax softens the gum. Elas tomers add flexibility. The molecular composition of a gum base is very similar to that of plastics and rubbers.

As said such gum bases are available commercially, for example from companies such as Cafosa or Gum Base Co.

Preferably, the compressed tablet according to the present invention comprises 55 - 80 wt-%, based on the total weight of the compressed tablet, of a gum base.

More preferably, the compressed tablet according to the present invention comprises 55 - 70 wt-%, based on the total weight of the compressed tablet, of a gum base.

Therefore, the present invention relates to a compressed tablet (CT4), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3) or (CT3’), wherein the compressed tablet comprises 55 - 80 wt-%, based on the total weight of the compressed tablet, of a gum base.

Therefore, the present invention relates to a compressed tablet (CT4’), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3) or (CT3’), wherein the compressed tablet comprises 55 - 70 wt-%, based on the total weight of the compressed tablet, of a gum base.

As stated above, the Vitamins used in the compressed tablet according to the present invention can be water-soluble Vitamins (such as Vitamin C and B complex Vitamins) and/or fat-soluble Vitamins (such as Vitamin E, D3, A, K).

Preferably, the compressed tablets according to the present invention comprises at least one water-soluble Vitamin and at least one fat-soluble Vitamin.

More preferably, the water-soluble Vitamins are chosen from the group consisting of Vit amin C, and B complex Vitamins. More preferably, the fat-soluble Vitamins are chosen from the group consisting of Vitamin E, and Vitamin A, Vitamin D3, and Vitamin K.

Therefore, the present invention relates to a compressed tablet (CT5), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4) or (CT4’), wherein the compressed tablet comprises at least one water-soluble Vitamin and at least one fat-sol uble Vitamin.

Therefore, the present invention relates to a compressed tablet (CT5’), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4) or (CT4’), wherein the compressed tablet comprises at least one water-soluble Vitamin chosen from the group consisting of Vitamin C, B complex Vitamins and at least one fat-soluble Vitamin chosen from the group consisting of Vitamin E, Vitamin A, Vitamin D3, and Vitamin K.

Preferably, the compressed tablet according to the present invention comprises 0.2 - 6 wt-%, based on the total weight of the compressed tablet, of at least one Vitamin.

More preferably, the compressed tablet according to the present invention comprises 0.8 - 4 wt-%, based on the total weight of the compressed tablet, of at least one Vitamin.

Therefore, the present invention relates to a compressed tablet (CT6), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4), (CT4’), (CT5) or (CT5’), wherein the compressed tablet comprises 0.2 - 6 wt-%, based on the total weight of the compressed tablet, of at least one Vitamin.

Therefore, the present invention relates to a compressed tablet (CT6’), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4), (CT4’), (CT5) or (CT5’), wherein the compressed tablet comprises 0.8 - 4 wt-%, based on the total weight of the compressed tablet, of at least one Vitamin. The compressed tablet according to the present invention can comprise any further ingre dient, which are commonly used such compressed tablets (chewing gums) according to the present invention.

Such ingredients (auxiliary compounds) are sweeteners, flavors, dilutents, and lubricants.

As stated above such ingredients are present in a compressed tablet according to the present invention in an amount of up to 60 wt-%, based on the total weight of the com pressed tablet.

Preferably the compressed tablet according to the present invention comprises 10 - 35 wt-%, based on the total weight of the compressed tablet, of at least one auxiliary com pound.

More preferably the compressed tablet according to the present invention comprises 15 - 30 wt-%, based on the total weight of the compressed tablet, of at least one auxiliary compound.

Therefore, the present invention relates to a compressed tablet (CT7), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4), (CT4’), (CT5), (CT5’), (CT6) or (CT6’), wherein the compressed tablet comprises 10 - 35 wt-%, based on the total weight of the compressed tablet, of at least one auxiliary compound.

Therefore, the present invention relates to a compressed tablet (CT7’), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4), (CT4’), (CT5), (CT5’), (CT6) or (CT6’), wherein the compressed tablet comprises 15 - 30 wt-%, based on the total weight of the compressed tablet, of at least one auxiliary compound.

Preferably, the auxiliary compounds used in the compressed tablet according to the pre sent invention chosen from the group consisting of sweeteners, flavors, diluents, and lub ricants.

Therefore, the present invention relates to a compressed tablet (CT8), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4), (CT4’), (CT5), (CT5’), (CT6), (CT6’), (CT7) or (CT7’), wherein the at least one auxiliary compound is chosen from the group consisting of sweeteners, flavors, diluents, and lubricants.

Optionally, the compressed tablet according to the present invention can be coated.

Such a coating is usually a film coating or a sugar coating. The amount of coating in rela tion to the core is small.

Therefore, the present invention relates to a compressed tablet (CT9), which is a com pressed tablet (CT), (CT1), (CT2), (CT2’), (CT3), (CT3’), (CT4), (CT4’), (CT5), (CT5’), (CT6), (CT6’), (CT7), (CT7’) or (CT8), wherein the compressed tablet according to the present invention is coated.

Therefore, the present invention relates to a compressed tablet (CT9’), which is a com pressed tablet (CT9), wherein the coating is a film coating or a sugar coating.

Such coating materials are available commercially. For example film coating material such as Nutrafinish ® available from Colorcon.

It is also possible to add other ingredients to the coating. Such ingredients can be any commonly used ingredients in such coatings (such as dyestuffs, flavors, sweeteners).

The compressed tablets are produced by using commonly known methods.

A general way to produce the compressed tablets according to the present invention is the following:

First, mix L-Theanine, Camomile extract, gum base, and other diluents for 10 to 15 mins in a V-shaped blender without chopping.

Then add flavors and sweetners and mix for 1 to 5 mins. Add sieved lubricant (through a 20-40 mesh screen), mix for up to 5 mins. Compress tablets using a rotary press (pressure up to 45 kN).

The following examples serve to illustrate the invention. Examples Example 1

Table 1. Formulation of core tablets

Core tablets procedures:

1. Weigh all ingredients in appropriate containers.

2. Pass all solid ingredients except Calcium Stearate through a #16 mesh sieve.

3. Add sorbitol to Hobart mixer, then add liquid flavor to mix for 5 minutes at low speed. Pass through #16 mesh again.

4. Mix all solid ingredients except Calcium Stearate for 20 mins in a V blender. If any lumps are seen, pass through 16 mesh sieve again.

5. Pass Calcium Stearate through #40 mesh sieve. Add to step 4 and mix for another 2 minutes.

6. Compress tablets on a “D” rotary press using round 0.8125” standard con cave toolings. Compression force: 6000 LBs. Press speed: 55 rpm Table 2. Coating compositions

Coating procedures:

1. Weigh 100 g of Nutrafinish 131 U 180003 White, 100g of Nutrafinish 132U 190008 Clear, 1 g of sucralose, 3.5 g of strawberry flavor, and 0.02 g of FDC Red 40 lake. Mix them in a poly bag for 5 minutes.

2. Use appropriate amount of water, and add step 1 to water to make 20% dispersion (solid content 20% w/w) with low shear mixing for at least 40 minutes.

3. Weigh 900 g of core tablets and place into the coating pan.

4. Tumble the tablets in the pan coater and pump coating dispersion using a Masterflex pump. Perform film coating with the following parameters: atomization pressure- 2 bar; pattern air- 0.5 bar; product temperature NMT (not more than) 38.5 °C; pan speed: 25 rpm; spray rate: NMT 3.5 g/min; target weight gain- 6%.