Product & Technology

1.) The Technology of the XStraw®? How does the Device work?

 

Very often, drugs are administered orally in the form of a tablet (in all variations) or a hard or soft capsule respectively. Everybody who has swallowing difficulties for whatever reason is longing for an easy yet effective drug delivery opportunity. A lot of developments are done or under way with orally dispersible forms (e.g. oral film or sublingual tablets), however, the pharmacodynamics (and thus also the pharmacokinetics) are very much dependent on the route of administration. In many cases, the same route is preferable than already designed in the form of a tablet or capsule. Here, the XStraw® offers a smart solution. Especially for children and elderly people. And finally for everybody who wants it the easy way.Pellets or granules containing the active ingredient, in most cases with a taste-masking in form of a coating, in some cases with an (additional) enteric coating, are delivered in form of an oral suspension to the stomach and the GI tract. The pellets / granules are contained in a drinking straw, which can be used with the most favorable drink and therefore are very easy to swallow. The patient can hardly feel that solid particles are swallowed. Taste only derives from the drink but none from the medicine.

That is also a clear advantage over oral suspensions.






 

 

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2.) Drugs which can be filled into this Drug Delivery Device?

 

In principal, all products that can be formulated as solid multi-particulates (pellets or granules) are possible in the XStraw® as long as certain physical parameters are within a range most important: particle size distribution within 250 – 710 μm with a low content of fines; The multi-particulates must not be to soft;

There is no limitation in the diversification of API and products, however, the product needs to have a certain value simply because the drug delivery device adds to the cost and if price is the only means of diversification just let it be...please refer to cost and pricing.

Not only pharmaceutical but also nutraceutical and all kind of healthcare products are well administered with the XStraw®

 

 


 

3.) Selection of possible Drugs to be filled into this Drug Delivery Device

 

HIV (human immunodeficiency virus)
API - Nomenklatur Comment
abacavir

from 14 kg

abacavir / lamivudine

from 12 years

atazanavir

from 6 years

darunavir

from 6 years

efavirenz

from 3 months / 3.5 kg

elvitegravir / cobicistat / emtricitabine / tenofovir / alafenamide

from 12 years / 35 kg

emtricitabine

from 4 months / from 33 kg

fosamprenavir

from 6 years / 39 kg

lamivudine

from 6 years

lamivudine

from 14 kg

lopinavir / ritonavir

from 2 years

nevirapine
from 3 years 
(suspension also younger)
raltegravir

from 6 years

raltegravir

from 2 years

tenofovir

from 2 years

tipranavir
from 2 years
(up to 12 years)
zidovudine

from 14 kg

hepatitis B
API - Nomenklatur Comment
entecavir

hepatitis C
API - Nomenklatur Comment
ribavirin

from 3 years

phenylketonuria / BH-4 deficiency
API - Nomenklatur Comment
sapropterin

from 4 years

pulmonary hypertension
API - Nomenklatur Comment
bosentan

from 1-2 years

sildenafil

from 1 year

bacterial infections
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clindamycin
impenem / cilastatin

from 0 years

telithromycin

from 12 years

prophylaxis CMV disease after organ transplantation
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valganciclovir

from 0 years

schizophrenia
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aripiprazole

from 15 years

paliperidone

from 15 years

risperidone

from 5 years

leukemia
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imatinib

from 1 year

mercaptopurine

from 0 years

urea storage disorder
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sodium phenylbutyrate

from 0 years

subependymal giant astracytoma due to tuberous sclerosis
API - Nomenklatur Comment
everolimus

from 1 year

epilepsy
API - Nomenklatur Comment
lamotrigine

from 12 years

levetiracetam

from 1 month

levetiracetam

from 12 years

oxcarbazepine

from 6 years

perampanel

from 12 years

stiripentol

from 0 years

topiramate

from 2 years

valproic acid

from 6 months

Zonisamid

ab 6 Jahren

cystic fibrosis
API - Nomenklatur Comment
ivacaftor

from 6 years

ulcerative colitis
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infliximab

from 6 years

Iron overload in thalassemia (including sickle cell anemia)
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deferasirox

from 10 years

hydroxycarbamide

from 2 years

muscle relaxant
API - Nomenklatur Comment
baclofen

from 33 kg

high blood pressure
API - Nomenklatur Comment
amlodipin

from 6 years

enalapril

from 6 years

lisinopril

from 6 years

losartan

from 6 years

valsartan

from 6 years 

ADHD
API - Nomenklatur Comment
atomoxetine

from 6 years

dexamfetaminhemisulfat

from 6 years

lisdexamfetamine

from 6 years

methylphenidate

from 6 years

malaria (also prevention)
API - Nomenklatur Comment
atovaquone / proguanil

from 5-11 kg

dihydroartemisinin /piperaquine

from 6 months/5 kg

cholesterol
API - Nomenklatur Comment
atorvastatin

from 10 years

ezetimibe

from 10 years

pravastatin

from 8 years

rosuvastatin hemicalcium

from 10 years

simvastatin

from 10 years 

travelers' diarrhea
API - Nomenklatur Comment
racecadotril

from 3 months

rifaximin

from 12 years

hay fever, allergies, hives / allergic rhinitis
API - Nomenklatur Comment
bilastine

from 12 years

desloratadine

from 2 years

desloratadine / pseodoephedrine

from 12 years

fexofenadine

from 6 years

levocetirizine

from 2 years

montelukast

from 15 years

rupatidin

from 12 years

prevention organ rejection after transplantation
API - Nomenklatur Comment
mycophenolate

from 2 years

tacrolimus

from 0 years

reflux disease (stomach acid)
API - Nomenklatur Comment
esomeprazole

from 1 year

lansoprazole
omeprazole

homocystinuria
API - Nomenklatur Comment
betaine

lennox-gastaut-Syndrom
API - Nomenklatur Comment
rufinamide

pain
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oxcarbazepine

from 12 years

sumatriptan

from 12 years

depressions
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fluoxetine

from 8 years

essence. thrombocythemia
API - Nomenklatur Comment
anagrelide

from 5 years

tyrosinemia type I
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nitisinone

from 0 years 

obesity
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orlistat

from 12 years

arthritis
API - Nomenklatur Comment
methotrexate

from 16 years

sulfasalazine

from 6 years

type 2 diabetes
API - Nomenklatur Comment
metformin

from 10 years

leishmaniasis (Kala Azar)
API - Nomenklatur Comment
miltefosine

from 3 years

morbus wilson
API - Nomenklatur Comment
zinc acetate dihydrate

from 1 year

fungal infections
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isovuconazole
voriconazol

from 2 years

nausea (e.g., chemotherapy)
API - Nomenklatur Comment
ondansetron

from 2 years

acetylglutamate synthase deficiency
API - Nomenklatur Comment
carglumic acid

from 0 years

asthma
API - Nomenklatur Comment
fluticasone

from 4 years

 


 

4.) Which active ingredients can you currently provide to be filled in the XStraw®?

 

Currently there are proven formulations for 3 antibiotics: Clarithromycin, amoxicillin / clavulanic acid (7 : 1) and cefpodoxime. These products have already been available in XStraw® on the European and South American markets.

Available from 2019 onwords, newly formulated antibiotics from Hisun, China. Likewise a pharmacutical company based MENA region started to develop formulation for the following indications: HCV, Multiple Sclerosis, Sickle Cell, Anemia, Alzheimer disease.

 


 

5.) Will you also fill XStraw® with specific products?

 

We do not plan to develop our own DS-Technology products. We assist our customers and companies in developing their products – and, as partners, provide support along the entire process chain according to individual wishes and requirements.

From brainstorming to the project study, to the machine design, manufacturing and the production and logistics chain. For existing originator products, which have not been developed for the XStraw® and therefore are not in the form of pellets, it may be possible to develop an optimized particle size distribution for the XStraw®.

 


 

6.) Device & Product

 

Device considerations

  • Device was tested for use with children from 2 years on within clinical trial („DoSeiT Study“)
  • Device was tested concerning fluid mechanics (pressure drop and sucking profile) by children from 1,5 years on during development
  • Device was tested concerning child safety (holes in the cap to avoid suffocation etc.)

Product considerations

  • Best possible palatability
  • Best possible taste-masking
  • Yet, reasonable effort in manufacturing the multi-particulates for economic reasons
  • Long shelf-life beyond 24 months

 

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7.) Are there any special features?

 

There are holes situated in the top part due to an EN/DIN standard for children’s toys. Should children swallow the cap, the air holes prevent choking.

This was also tested in the past with Grünenthal by a Nuremberg institute. Furthermore there is an “olive” inside the cap, which guarantees the cap’s locking in place onto the shaped straw and thus a reliable closure.

 


 

8.) What are the materials of the components of the XStraw® made?

 

Polypropylen (food grade approved)

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Polyethylen (food grade approved)

 

 


 

9.) What about the control filter?

 

1. Closure located at the bottom of the straw, pellets cannot fall out
 
2. Prevents the penetration of liquids into the straw from the bottom when placing it into the beverage; dissolving of the pellets is avoided (coating remains intact).
3. The liquid penetrates the control filter when suction is applied. Its structure changes (pores open). This is how the pellets are mixed/dispersed and conveyed into the patient with the flow of liquid. The patient then swallows the pellets together with the liquid. The control filter also moves upwards with the flow of liquid and remains in position.
 
4. Control function: After pellet intake, the control filter remains in the mouthpiece area of the straw – indicating the patient’s drug consumption to the parents/caregiver.
 

 


 

10.) Do you sell the technology (filling machines) or do you also supply filled XStraw®?

 

We organize the supply changefor the components (caps, straws, filters) for production, and you can then fill the product on-site or at a contract manufacturer of your choice.

 


 

11.) What is the typical shelf-life of products filled into the XStraw®?

 

  • The former owner of the IP rights performed stability tests with the result of a shelf-life of minimum 24 months for its antibiotics
  • Since a desiccant cap is possible even moisture sensitive products can be stored for this period
  • We assume that the shelf-life is the same as for the corresponding tablet or capsule formulation
  • Besides silicagel as a standard desiccant, molucular sieves can also be formulated in the cap material in order to have the hightest possible moisture extractio
  • In case of oxygen-sensitive products, nitrogen flushing can be applied on the packing machine to replace oxygen from the air in a pouch or stick-pack
 

 


 

12.) How to manufacture the XStraw®?

 

DST_LS , output:
 
  • approx. 800,000 / a (single shift operation)
  • dosing amount 100-1.400 mg/XStraw® (higher and lower drug loads to be tested)
  • dosing by vacuum dosator

Media Folder: 

Media Folder: 
  • Timeline:
  • From PO to operation approx.
  • 6 months
DST_HS , output:
 
  • approx. 15 – 20 million / a (single shift operation)
  • dosing amount 100-1.400 mg/XStraw® (higher and lower drug loads to be tested)
  • dosing by vacuum dosator

 

  • Operation:
  • Fully automatic, one operator for assembly, filling and pouching process is enough

 

  • Timeline:
  • From PO to operation approx.
  • 12 months

 


 

13.) Differences to competitor straw products

 

Main difference is the working principle!

Our XStraw® delivers multi-particulates (= product based on pellets or granules) as solid dispersion which does not dissolve during intake. Release of the API(s) is similar to a coated tablet or a hard capsule.

All other products in any straw – type device must dissolve during intake, otherwise the product doesn’t work. This is similar to a orodispersible tablet or an orodispersible film.