GB2527885A

GB2527885A - Oxidative formulation

Info

Publication number: GB2527885A
Application number: GB1505433.1A
Authority: GB
Inventors: Andrew Best; David Best
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-03-28
Filing date: 2015-03-30
Publication date: 2016-01-06
Anticipated expiration: 2035-03-30
Also published as: GB2527885B; GB2527885A9; GB201405602D0; GB201505433D0

Abstract

A formulation comprising a halogen-containing oxidiser and a gelling agent. The formulation is used for treating hazardous waste such as controlled drugs and contaminated medical waste such as discarded blood products, sharps or other materials that have contacted bodily fluids. The waste may originate from hospitals, clinics, veterinary clinics, pharmacies or tattoo studios. The halogen containing oxidiser may be selected from calcium hypochlorite, calcium hypobromite, sodium hypochlorite, sodium hypobromite, sodium bromated and barium hypochlorite. The gelling agent is ideally a super absorbent polymer such as polyacrylate or polyacrylate salts, a natural gum or organic starch. The formulation may include a taste deterrent, dye, activated carbon and desiccant. Ideally, the formulation is supplied as a powder which is combined with water. The formulation may form part of a drug denaturing kit. A method of use is also disclosed.

Description

Oxidative Formulation

Field of the Invention

The present invention relates to an oxidative formulation. The fornaulation may he used in the safe disposal of potentially hazardous waste.

Background to the Invention

There is Frequently a need to dispose safely of waste that may he contarninared by bodily fluids as well as waste medicine products, and in particular waste controlled drugs, in order to prevent accidental or abusive ingestion. Potentially contaminated medical waste naay include discarded blood products, sharps. or other supplies that may have been in contact with blood or other body fluids. This lype of medical waste may originate from many different sources, including hospitals. clinics, veterinary clinics, pharmacies, tattoo studios, and needle exchange programs.

Pharmaceuticals are used widely for medical and veterinary treatment and in research facilities. Many counties of the world control the use of certuin drugs. these medicines are called controlled medicines or controlled drugs. Classification of controlled drugs is based on their benefit when used in medical treatment and their harm if misused. this classification is into five schedules, where schedule 1 represents the highest category.

Schedule 1 drugs are typically not used in prescription medicines therefore for the purpose of the invention focus is directed to controlled drugs of interest in schedule 2 and below. Schedule 2 drugs, of which there are over one hundred, typically are opiates.

Examples of those that are classified into schedule 2 include morphine, pethidine and niothadone.

Stricter legal controls apply to controlled drugs, than to other drugs, to prevent them from being misused, obtained illegally and/or causing harm. these legal controls govern how controlled drugs may he produced, stored, supplied, prescribed and disposed Of.

in the LK the destruction of schedule I and schedule 2 drugs can only he in the presence of a person authorised under the _\tisuse of Drugs Act 1971 and the Misuses of Drug Regulations 2001 (and any subsequent amendments). This does not apply to prescription drugs once dispensed to a patient hut is typically applied as good practice.

Any unused controlled drugs prescribed and dispensed to a patient may he and are encouraged to he returned to pharmacies. doctors surgeries and health care professionals for destruction. Unused veterinary medicines are encouraged to and are typically returned to the dispensing veterinary practice for destruction.

The. Royal Pharmaceutical Society guidance. on the safe. destruction of controlled drugs (2007) indicates that patient returned controlled drugs must not be re-used or entered into the controlled drug register and should be destroyed as soon as possible in order to avoid storage problerns' and an increased security risk. burtherniore the Royal Pharmaceutical Society recommends that, "Pharmacists are strongly advised to denature controlled drugs and render them irretrievable as soon as possible." Some denaturing methods that have been nsed include addition of liquid dose fonnulations to be absorbed by an appropriate amount of cat litter, or similar product; crushing and placing solid dose formulations into a small amount of soapy water whilst ensuring the drug has fully dissolved or dispersed in the water; crushing with a pestle inside an empty plastic container of ampoules of parenteral formulations followed by addition of a small qu2mtity of hot soapy water or cat litter; rendering active ingredients in patches irretrievable by removing the backing and foUing the patch upon itself. In each case once the procedure had been carried out, the resultant mixture was added to the general pharmaceutical waste. In many of the above methodok)gies there is no clear evidence that the technique employed denatures the controlled drug and renders it irretrievable.

the current con tnon means of carrying out the Royal Pharmaceutical Society recommendation is to use a controlled drug denaturing kit. there are a number of controlled drug denaturing kits commercially available fbr denaturing controlled drugs. It has been reported in the literature, for controlled drugs in tablet and capsule form, that these kits do not actually denature the controlled drug, rather they simply denature the drug delivery form, that is the tablet or capsule. and encapsuhte the drug in a gel substance. Current guidelines require controlled drug denaturing kits to he securely stored for only 48 hours, after which they can he disposed of as pharmaceutical waste.

Therefore if the drug has only been encapsulated and not deconstructed there is a potential abuse opportunity and an opportunity for accidental digestion.

Some of the commercial drug denaturing kits also include a taste deterrent so that even if a drug denaturing kit were to fall into the wrong hands, using the drug contained within the gel substance would be unpleasant. This would hopefully prevent accidental digestion of potentially harmful drugs. It is recognised that this would not deter, for example, a determined drug dealer and/or addict.

Aside from the denaturing of controlled drugs that have been prescribed there are illicit drugs (contraband) that must be disposed of when seized by law enforcement officers.

At present it is common for such seized drugs to be disposed of in the public sewerage system. there is no clear evidence that the technique employed deconstructs the controlled drug and renders it irretrievable.

Also to be considered are laboratory controlled drug specimens which may have been udlised in research progranunes and need to be denatured and disposed of.

Used sharps. such as used needles, are typically disposed of using a designated sharps container. This is a container into which needles are dropped immediately after a single use. Sharps containers generally have a lid which can he secured. Problems can occur when transporting sharps containers and there is a serious risk of needle stick injury if the lids become unsecured, causing spillage of potentially contaminated needles.

Tattoo studios are another setting in which both sharps and potentially contaminated waste in the form of used tattoo inks require safe disposal. Used tattoo needles and leftover tattoo ink are potential sources of Hepatitis B or C contamination, amongst other potential contaminants. these clinical waste products must be disposed of via hazardous waste collections. Leftover ink is also difficult to safely dispose of due to i liquid nature.

It would he desirable to provide an improved method for disposing of potentially hazardous waste.

Summary of the Invention

Accordingly the invention provides a formulation which comprises a halogen-containing oxidiser, and a gelling agent.

Preferred halogens of the invention include chlorine. bromine and iodine with chlnnne and bromine being especially preferred. In the halogen-containing oxidiser the oxidising halogen may be supplied by any source that can ino1de free and/or combined halogen.

Examples of such halogen-containing oxidiser include calcium hypochlorite, calcium hypobromite, sodium hypochiorite, sodium hypobromite, sodium bromate and barium hypochiorite and mixtures thereof Especially preferred is calcium hypochiorite.

the gelling agent may include a super absorbent polymer, such as polyacrylate and polyactylate salts, polyacrylamide copolymer. ethylene maleic anhydride copolymer, crosslinked carboxymethyl cellulose, crosslinked polyethylene oxide; a natural gum, for example xanthurn gum; or an organic starch such as modified potato starch.

The formulation preferably Eirther comprises a taste deterrent. The taste deterrent is preferably odourless, non-toxic and non-carcinogenic. Examples of suitable taste deterren include pungent materials such as capsaicinoids and bitterants such as denatonium saccharide and denatonium benzoate.

\X'here the taste deterrent is a capsaicinoid, the pungency of the taste deterrent may he in excess of 1000 Scoville heat units.

Preferably. the formulation further comprises activated carbon.

Preferably, the formulation further comprises a desiccant. A suitable example of a desiccant is silica dioxide.

the fonnulaflon may further comprise a dye, such as the colour black.

A preferred embodiment of the formulation comprises in weight percentages: Super absorbent polymer -30-70% Activated carbon -20-50% Calcium hypochiorite -1-1 % Black dye -<5% Fused silica dioxide -<3'Vo (:apsiuicin -<3% An especially preferred embodiment of the formulation comprises in weight percettages: Super absorbent polymer -50.51% Activated carbon -39.5% Citicium hypochiorite -7.9% Black dye -0.5% Fused silica dioxide. -1.58% Capsaicin -0.01% The formulation of the invention may he used as a dmg denaturing fbrmulation.

The present invention further provides a drug denaturing kit comprising a formulation which comprises a halogen-containing oxidiser, and a gelling agent.

The formulation will typically be provided in the kit in a dry solid, for example powdered, state, with instnictions for use. Tn such a kit the dry components may he supplied premixed in the correct ratio ready to be dissolved in \vater for use.

the kit itself is typically in the form of a container comprising the formulation wherein the volume of the container is such that both the dmg and sufficient water can he added to the fonnulation to enable dissolving and interaction in situ.

According to the present invention there is provided a method of deconstructing the active ingredient in a controlled drug formulation comprising: a) addition of controlled drug to-'i drug denaturing kit comprising a formulation which comprises a halogen-containing oxidiser, and a gelling agent; h) addition of sufficient amount of water to dissolve the mixed ingredients of a) in; c) shaking vigorously to enable interaction between active ingredient of controlled drug and the formulation d) disposal of uscd drug denaturing kit comprising deactivated controlled drug.

The controlled drug can exist in many forms. For example solid drugs present in tablet form, capsule, antpoules; liquid drugs present in anapoules. syringes; patches as carriers for the drugs.

in one embodiment one or more tablets or capsules of controlled drug is placed into the dry solid formulation in the container, an amount of water is' £LILIec, for exanaple approximately 200ml, although it is not essential that this exact quantity is used. The container is then closed and shaken well.

it is preferable that the controlled drug tablets or capsules are added to the dry solid formulation before addition of water because there may be difficulty in mixing the drugs into a prefR)rmed gel. Typically the controlled drugs or tablets are ground up, nailled or othetwise crushed befire addition to the dry solid formulation. Alternatively the tablets can he added whole to the fornaulation. However it should he recognised that in certain circuntstarices the controlled dnig can he added to the formulation that has already been mixed with water. For exantple one or both components of the drug denaturing formulation may he provided in a dissolved fornt (in tvater, either ready for mixing together or as a concentrated stock solution ready to he diluted for use.

it is believed that the following interactions take place in the drug denaturing kit. The gelling agent absorbs the added water rapidly, within 60 seconds. then the halogen-containing oxidiser reacts with the controlled drug, breaking down its structure to render it inactive. When present, the function of the activated carbon is to hold on to molecules of high molecular weight.

Liquid controlled drugs can he added to the dry solld formulation before or after addition of water. Patches may need to he cut into small pieces prior to addition to the fornaulation.

Preferably the controlled drug is held within the drug denaturing kit for between 24 to 48 hours to ensure the active ingredient of the controlled drug has been rendered irretrievable prior to disposal.

The formulation of the invenhon may he used in the decontamination of hiohazardous waste. The hiohazardous waste may he sharps.

The present invention further provides a sharps disposal kit comprising a formulation which comprises a halogen-containing oxidiser, and a ge]ling agent.

The. formulation will typically be provided in the. kit in a dry solid, for example powdered state, with insiructions for use. In such a kit the dry components may he supplied prenaixed in the correct ratio ready to he dissolved in water for use.

The kit itself is typically in the form of a container comprising the formulation wherein the volume of the container is such that the container can he filled with sharps and then sufficient water added to the formulation to enable dissolving of the formulation and interacton with any contaminants in situ, typically the container would be filled with water after filling with sharps. Once filled with water the halogen-containing oxidiser reacts with any contaminants. The gelling agent absorbs the added water rapidly, within seconds. By encasing the sharps in gel the container can he transported much more safely, without risk of spillage of sharps. The risk of theft of used needles or syringes from a sharps container is also likely to he much reduced.

The hiohazardous waste may he contaminated hquids or potentially contaminated liquids. Leftover tattoo ink is an example of a potentially contaminated liquid that requires safe disposal and preferably decontamination. T3iohazardous liquid waste may he decontaminated through the addition of the formulation of the invention directly to the liquid waste.

The present invention further provides a hiohazardous liquid waste disposal kit comprising a formulation which comprises a halogen-contuining oxidiser, and a gelling :igent.

The formulation will typically he provided in the kit in a dry solid, for example powdered state, with instructions fur use. In such a kit the dry components may he supphed 1rmixed in the correct ratio ready to be added to liquid \vaste. The formulation may provided in the kit within one or more water soluble sachets.

Depending on the nature of the liquid waste, further water may or may not need to he mixed with the formulation.

Tf the liquid waste contains water then further water is not required to be added and the po\vdered formulation may be added directly to the liquid waste. The haogcn-containing oxidiser then reacts with any contaminants in the. waste, rendering it safe. In addition, the gelling agent present in the fornmlation absorbs the water present in the waste rapidly, within 60 seconds, solidifying the waste. Using the. fornmlation of the invention the liquid waste is decontaminated and also the risk of spillage is much reduced.

For liquid waste containing less water, the waste i-nay he diluted with water prior to the addition of the fonnulation.

The. present invenion will nov be described with reference to the Examples described below, it should be noted that the Examples are. provided by way of illustra6on only.

Examples

the effectiveness of the formulaion of the invenfion to deacvatc the active ingredient of conuollcd drugs is illustrated using thin layer chronatography (ftC).

Example 1

An aqueous ethanolic solution of Oramnorph (active ingredient morphine sulphate) was selected as a typical e.xamnple of a controlled drug. to 0.ig of Oramorph mixed with water (lOrnl) solid calcium hypochiorite (1g was added. The mixture was stirred well and left overnight. A sample of this mixture, alongside a sample of ()ramorph itself was subjected to TLC over a 24hr period on a silica gd plate (F254) run in a 1:1 mixture of ethyl acetate and tc)uene. The Oramorph contro' showed a major component remaining on the TLC baseline having a UV absorbance at 254nm whilst for the mixture there was no such component. this is indicative of reaction of the controlled drug with the calcium hyperchlorite which is synonymous with rendering the controlled drug inactive.

Further development of the ThC plate by the addition of 10% phosphomolybdic acid foUowed by healing showed a blue/green spot at the baseline for the control corresponding to the untreated Orarnorph. The treated Orarnorph showed otfly a faint ellow, almost white baseline spot.

Example 2

Example 1 was repeated except ()ramorph was firstly converted to its sulphate free base, i.e. Morphine. To O.lg of Oramorph mixed with water (Smi) sodium carbonate was added until pTTI 0 was reached and stirred for 5 mins to form a basic mixture. The basic mixture was extracte.d with a 1:1 mixture. of ethyl acetate and toluene and the organic phase separated and stripped to iow volume (-0.5ml), prior to the addition of ethanol (in-il) and water (in-il). To this morphine solution was added solid calcium hypochlorite (0.25g). the mixture was stirred well and left for 48 hours.

A sample of this mixture, alongside a sample of Morphine itself, was subjected to 1LC on a silica gel plate run in toluene. the Morphine control showed a major component remaining on the TLC baseline whilst for the mixture there was no such component.

Further development pf the TLC plate by the addition of 10% phosphomolybdic acid followed by heating showed strong colouring at the baseline for the control corresponding to the untreated Morphine. The treated Morphine showed effectively a clear baseline.

Claims

(:lthms 1. A formulation comprising a halogen-containing oxidiser, and a gelling agent.
2.Aforrnulation according to claim I wherein the halogen is chosen from chlorine, bromine and iodine.
3. A formulation according to claim 2 wherein the halogen is chlorine.
4. A formulation according to any previous claims wherein in the halogen-containing oxidiser the oxidising halogen may he supplied by any source that can provide free and/or combined halogen.
5.Aforrnulation according to any of claims 1,2 and 4 wherein the halogen-containing oxidiser is selected from calcium hypochlorite, calcium hypobromite, sodium hypochlorite, sodium hypobromite, sodiuni hronaate and barium hypochlorite.
6. A formulation according to claini 5 wherein the halogen-contuining oxidiser is calciuna hypochlorite.
7.Aforrnulation according to any previous claims wherein the gelling agent is chosen from a super absorbent polymer, a natural gum or an organic starch.
8. A formulation according to claim 7 wherein the gelling agent is a supc.r absorbent polymer.
9. A formulation according to any previous clainas further comprising a taste deterrent.
1O.A formulation according to any previous claims further comprising activated carbon.
ii. A formulation according to any previous claims further comprising a desiccant
12.Aforrnulation iccording to any previous claims further comprising a dye.
13. A formulation according to claim I which comprises in weight percentages: Super absorbent polymer -30-70% Activated carbon -20-30% Calcium hypochiorite -1-13% Black dye -<5% bused silica dioxide. -<5% Capsaicin -<5%
14. A fonulation according to claim 13 which comprises in weight percentages: Super absorbent polymer -50.51% Activated carbon -39.5% Calcium hypochlorite -7.9% Black dye -0.5% bused silica dioxide -1.58% Capsaicin -0.01%
15. A formulation according to any of claims I to 14 for use as a drug denaturing formulation.
16. A dnig denaturing kit comprising a formulation according to any of claims 1 to 14.
17. A drug denaturing kit according to claim 16 wherein the formulation is provided in the kit in a dry solid state.
18. A drug denaturing kit according to either of claims 16 or 17 wherein the kit is in the form of a container comprising the formulation wherein the volume of the container is such that the drug and sufficient water can he added to the formulation to enable dissolving and interaction in situ.
19. A method of deconstructing the active ingredient in a controlled drug Formulation comprising: a) addition of controlled drug to a dmg denaturing kit comprising a formulation according to any of claims ito 14; b) addition of sufficient amount of water tc dissolve the mixed ingredients of a) in; c) shaking vigorously to enable interaction betveen active ingredient of controlled drug and the formulation; d) disposal of used drug destruction kit comprising deactivated controlled drug.
20. A method according to claim i9 wherein disposal of used drug destruction kit comprising deactivated controlled drug is betveen 24 to 48 hours after interaction between active ingredient of controlled drug and the formulation.
21. A method according to either of claims 19 and 20 wherein the controlled drug is chosen from a solid drug in tablet, capsule, and/or ampoule form; a liquid drug in an ampou]e and/or syringe; as p of a p2ttth.
22. A method according to claim 21 wherein the controlled drug is solid in tahle.t and/or capsule form.
23. A formulation according to any of claims i to i4 for use. in the disposal of hiohazardous was te.
24. A formulation according to clam 23, wherein the biohazardous waste is tattoo ink.
25. A formulation according to claim 23, wherein the hiohazardous waste is sharps waste..
26. A kit for the disposal of biohazardous waste comprising a formulation according to any of claims 1 to 14.
27. A kit according to claim 26, wherein the formulation is provided in the kit in a dry solid state.
28. A kit according to claim 26 or 27 wherein the waste is tattoo ink.
29. A kit according to daim 26 or 27 wherein the waste is sharps waste.