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 Bemerkung
Abacavir

ab 14 kg

Abacavir / Lamivudine

ab 12 Jahren

Atazanavir

ab 6 Jahren

Darunavir

ab 6 Jahren

Efavirenz

ab 3 Monaten / 3.5 kg

Elvitegravir/ Cobicistat / Emtricitabin / Tenofovir / Alafenamid

ab 12 Jahren / 35 kg

Emtricitabin

ab 4 Monaten / ab 33 kg

Fosamprenavir

ab 6 Jahren / 39 kg

Lamivudin

ab 6 Jahren

Lamivudin

ab 14 kg

Lopinavir / Ritonavir

ab 2 Jahren

Nevirapin
ab 3 Jahren
(Suspension auch jünger)
Raltegravir

ab 6 Jahren

Raltegravir

ab 2 Jahren

Tenofovir

ab 2 Jahren

Tipranavir
ab 2 Jahren
(bis ca. 12 Jahren)
Zidovudin

ab 14 kg

Hepatitis B
API - Nomenklatur Bemerkung
Entecavir

Hepatitis C
API - Nomenklatur Bemerkung
Ribavirin

ab 3 Jahren

Phenylketonurie / BH-4-Mangel
API - Nomenklatur Bemerkung
Sapropterin

ab 4 Jahren

Lungenhochdruck
API - Nomenklatur Bemerkung
Bosentan

ab 1 Jahr / ab 2 Jahren

Sildenafil

ab 1 Jahr

bakterielle Infektionen
API - Nomenklatur Bemerkung
Clindamycin
Impenem / Cilastatin

ab 0 Jahren

Telithromycin

ab 12 Jahren

Prophylaxe CMV-Erkrankung nach Organtransplantationen
API - Nomenklatur Bemerkung
Valganciclovir

ab 0 Jahren

Schizophrenie
API - Nomenklatur Bemerkung
Aripiprazol

ab 15 Jahren

Paliperidon

ab 15 Jahren

Risperidon

ab 5 Jahren

Leukämie
API - Nomenklatur Bemerkung
Imatinib

ab 1 Jahr

Mercaptopurin

ab 0 Jahren

Harnstoffwechselstörung
API - Nomenklatur Bemerkung
Natriumphenylbutyrat

ab 0 Jahren

Subependymales Riesenastrazytom aufgruund tuberöser Sklerose
API - Nomenklatur Bemerkung
Everolimus

ab 1 Jahr

Epilepsie
API - Nomenklatur Bemerkung
Lamotrigin

ab 12 Jahren

Levetiracetam

ab 1 Monat

Levetiracetam

ab 12 Jahren

Oxcarbazepin

ab 6 Jahren

Perampanel

ab 12 Jahren

Stiripentol

ab 0 Jahren

Topiramat

ab 2 Jahren

Valproinsäure

ab 6 Monaten

Zonisamid

ab 6 Jahren

Nephropathische Cystinose
API - Nomenklatur Bemerkung

Mukoviszidose
API - Nomenklatur Bemerkung
Ivacaftor

ab 6 Jahren

Colitis ulcerosa
API - Nomenklatur Bemerkung
Infliximab

ab 6 Jahren

Eisenüberladung bei Thalassämie (u.a. Sichelzellanämie)
API - Nomenklatur Bemerkung
Deferasirox

ab 10 Jahren

Hydroxycarbamid

a 2 Jahren

Muskelrelaxanz
API - Nomenklatur Bemerkung
Baclofen

ab 33 kg Körpergewicht

Bluthochdruck
API - Nomenklatur Bemerkung
Amlodipin

ab 6 Jahren

Enalapril

ab 6 Jahren

Lisinopril

ab 6 Jahren

Losartan

ab 6 Jahren

Valsartan

ab 6 Jahren

ADHS
API - Nomenklatur Bemerkung
Atomoxetin

ab 6 Jahren

Dexamfetaminhemisulfat

ab 6 Jahren

Lisdexamfetamin

ab 6 Jahren

Methylphenidat

ab 6 Jahren

Malaria (auch Prävention)
API - Nomenklatur Bemerkung
Atovaquon / Proguanil

ab 5 - 11 kg

Dihydroartemisinin / Piperaquin

ab 6 Monaten / 5 kg

Cholesterin
API - Nomenklatur Bemerkung
Atorvastatin

ab 10 Jahren

Ezetimib

ab 10 Jahren

Pravastatin

ab 8 Jahren

Rosuvastatin-Hemicalcium

ab 10 Jahren

Simvastatin

ab 10 Jahren

Reisediarrhö
API - Nomenklatur Bemerkung
Racecadotril

ab 3 Monaten

Rifaximin

ab 12 Jahren

Heuschnupfen, Allergien, Nesselsucht / allergische Rhinitis
API - Nomenklatur Bemerkung
Bilastin

ab 12 Jahren

Desloratadin

ab 2 Jahren

Desloratadin / Pseodoephedrin

ab 12 Jahren

Fexofenadin

ab 6 Jahren

Levocetrizin

ab 2 Jahren

Montelukast

ab 15 Jahren

Rupatidin

ab 12 Jahren

Prävention Organabstoßung nach Transplantation
API - Nomenklatur Bemerkung
Mycophenolatmofetil

ab 2 Jahren

Tacrolimus

ab 0 Jahren

Refluxkrankheit (Magensäure)
API - Nomenklatur Bemerkung
Esomeprazol

ab 1 Jahr

Lanzoprazol
Omeprazol

Homocystinurie
API - Nomenklatur Bemerkung
Betain

Lennox-Gastaut-Syndrom
API - Nomenklatur Bemerkung
Rufinamid

Schmerz
API - Nomenklatur Bemerkung
Oxycodon / Naloxon

ab 12 Jahren

Sumatriptan

ab 12 Jahren

Depression
API - Nomenklatur Bemerkung
Fluoxetin

ab 8 Jahren

essenz. Thrombozythämie
API - Nomenklatur Bemerkung
Anagrelid

ab 5 Jahren

Tyrosinämie Typ I
API - Nomenklatur Bemerkung
Nitisinon

ab 0 Jahren

Adipositas / Fettleibigkeit
API - Nomenklatur Bemerkung
Orlistat

ab 12 Jahren

Arthritis
API - Nomenklatur Bemerkung
Methotrexat

< 16 Jahren

Sulfasalazin

ab 6 Jahren

Diabetes Typ 2
API - Nomenklatur Bemerkung
Metformin

ab 10 Jahren

Leishmaniase (Kala Azar)
API - Nomenklatur Bemerkung
Miltefosin

ab 3 Jahren

Morbus Wilson
API - Nomenklatur Bemerkung
Zinkacetat dihydrat

ab 1 Jahr

Pilzinfektionen
API - Nomenklatur Bemerkung
Isovuconazol
Voriconazol

ab 2 Jahren

Übelkeit (z.B. bei Chemotherapie)
API - Nomenklatur Bemerkung
Ondansetron

ab 2 Jahren

Acetylglutamat-Synthase-Mangel
API - Nomenklatur Bemerkung
Carglumsäure

ab 0 Jahren

Asthma
API - Nomenklatur Bemerkung
Fluticason

ab 4 Jahren

 


 

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.